aapm 2014 annual meeting abstracts

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AAPM 2014 ANNUAL MEETING ABSTRACTS Epidemiology/Health Policy/Education 100 An Analgesic Challenge: Major Spine Surgery in a Patient on Buprenorphine/Naloxone Martin Jacobson, [email protected] 1 , Stephen Lucas, MD 1 , Brittany Adams, MD 1 , (1) University of Florida, Gainesville, FL Introduction: Buprenorphine/Naloxone is becoming more frequently used in the setting of outpatient narcotic dependence. It is a partial mu receptor agonist and weak kappa antagonist with a long duration of action. It is approximately 25–40 times more potent than morphine and may be safer than methadone for outpatient manage- ment of opioid addiction and detoxification. (Auria- combe, 2001; Ducharme, 2012). Due to its partial agonist/antagonist nature, buprenorphine exerts its effects by avidly binding to opioid receptors, thus antago- nizing any subsequently administered opioids (Huxtable, 2011). This can make the peri-operative management of acute surgical pain quite challenging. Case: An 18-year- old female with chronic pain presented for anterior inter- body fusion for correction of lumbar spondylolisthesis. Upon reviewing her medical history, it was discovered that she is managed outpatient with a buprenorphine / naloxone transdermal patch (5 mcg/hr) for her chronic back pain. After careful discussion of pain management options with the patient and family, a lumbar epidural catheter was placed preoperatively and dosed with 0.5% ropivacaine. The epidural along with a ketamine infusion were used peri-operatively to provide analgesia. The epi- dural was removed 4 days postoperatively. The patient reported adequate pain scores throughout her hospital- ization. References: 1) Auriacombe M., Franques P., Tignol J., Deaths Attributable to methadone vs buprenorphine in France [Letter]. JAMA. 2001; 285: 45. 2) Ducharme S., Fraser R., Gill K., Update on the clinical use of buprenorphine in opioid-related disorders. Cana- dian Family Physician. 2012; 58(1): 37–41, 3) Huxtable C., Roberts L., Somogyi A., Macintyre, P., Acute Pain management in opioid-tolerant patients: a growing chal- lenge. Anesthesia Intensive Care. 2011; 39: 804–823. Funding: None 101 Impacting Opioids Prescribing Practices of Primary Care Providers Through Innovative Use of Tele-Health Technology Ali S Mchaourab, MD, [email protected] 1 , Scott K Ober, MD MBA 2 , Sherry Ball, PhD 3 , Katharine E Harpley, MMS PA-C 4 , Christopher Lacey, PharmD 5 , (1) Louis Stokes VAMC, Cleveland, OH, (2) Associate Professor, Cleveland, OH, (3) Louis Stokes Cleveland Department of Vet, Cleveland, OH, (4) Cleveland Veterans Affairs Med Center, Cleveland, OH, (5) Cleveland Veterans Affairs Medical Center, Cleveland, OH Introduction: In its 2nd year of running a specialty care access network (SCAN-ECHO), the Cleveland VA SCAN-ECHO project is assessing the impact of this training on provider’s opioids prescribing practices. Methods: A core group of primary care providers (PCPs) from 13 remote outpatient clinics participated in a year-long pilot whereby they dialed into a video- teleconference session with the pain specialty team at the main campus. The sessions included both a didactic pre- sentation given by a member of the specialty team and case discussions of patients the PCPs would have other- wise referred to the specialty clinic at the main campus. The specialists provided recommendations to the PCP that the PCP could then employ during their next appointment with the patient. Success of the program was assessed by quantifying the number of opioid anal- gesics prescriptions at each site before intervention and during the first 6 months of years 1 and 2 post interven- tion. A significant reduction in opioids prescription indi- cates improved knowledge of multi-disciplinary pain management skills versus a problematic passive pattern of opioids prescribing that is a common practice in the US. Results: Preliminary data shows that the number opioid analgesic prescriptions significantly (p < 0.05) declined in clinics impacted by the SCAN-ECHO project. Conclu- sions: This pilot study reveals positive outcomes in terms of opioids prescribing practices. We suggest involving PCPs in a 1-year academic project such as this. It can not only improve their knowledge and skills but can impact their opioids prescribing practices. References: 1) Arora Sanjeev et al. Outcomes of Treatment for Hepatitis C Virus Infection by Primary Care Providers. N ENGL J MED 364;23 June 9, 2011. 2) Arora Sanjeev et al. Project ECHO: Linking University Specialists with rural and Prison-Based Clinicians to Improve Care for People with Chronic Hepatitis C in New Mexico. Public Health Reports; 2007 supplement 2; vol 122. 3) Arora Sanjeev PAIN MEDICINE Volume 15 Number 3 2014 © American Academy of Pain Medicine 1526-2375/15/$15.00/485 485–537 doi:10.1111/pme.12399

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Page 1: AAPM 2014 Annual Meeting Abstracts

AAPM 2014 ANNUAL MEETING ABSTRACTS

Epidemiology/Health Policy/Education

100An Analgesic Challenge: Major Spine Surgery in aPatient on Buprenorphine/NaloxoneMartin Jacobson, [email protected],Stephen Lucas, MD1, Brittany Adams, MD1,(1) University of Florida, Gainesville, FLIntroduction: Buprenorphine/Naloxone is becomingmore frequently used in the setting of outpatient narcoticdependence. It is a partial mu receptor agonist and weakkappa antagonist with a long duration of action. It isapproximately 25–40 times more potent than morphineand may be safer than methadone for outpatient manage-ment of opioid addiction and detoxification. (Auria-combe, 2001; Ducharme, 2012). Due to its partialagonist/antagonist nature, buprenorphine exerts itseffects by avidly binding to opioid receptors, thus antago-nizing any subsequently administered opioids (Huxtable,2011). This can make the peri-operative management ofacute surgical pain quite challenging. Case: An 18-year-old female with chronic pain presented for anterior inter-body fusion for correction of lumbar spondylolisthesis.Upon reviewing her medical history, it was discoveredthat she is managed outpatient with a buprenorphine /naloxone transdermal patch (5 mcg/hr) for her chronicback pain. After careful discussion of pain managementoptions with the patient and family, a lumbar epiduralcatheter was placed preoperatively and dosed with 0.5%ropivacaine. The epidural along with a ketamine infusionwere used peri-operatively to provide analgesia. The epi-dural was removed 4 days postoperatively. The patientreported adequate pain scores throughout her hospital-ization. References: 1) Auriacombe M., Franques P.,Tignol J., Deaths Attributable to methadone vsbuprenorphine in France [Letter]. JAMA. 2001; 285: 45.2) Ducharme S., Fraser R., Gill K., Update on the clinicaluse of buprenorphine in opioid-related disorders. Cana-dian Family Physician. 2012; 58(1): 37–41, 3) HuxtableC., Roberts L., Somogyi A., Macintyre, P., Acute Painmanagement in opioid-tolerant patients: a growing chal-lenge. Anesthesia Intensive Care. 2011; 39: 804–823.Funding: None

101Impacting Opioids Prescribing Practices ofPrimary Care Providers Through Innovative Use ofTele-Health TechnologyAli S Mchaourab, MD, [email protected],Scott K Ober, MD MBA2, Sherry Ball, PhD3,Katharine E Harpley, MMS PA-C4, Christopher Lacey,PharmD5, (1) Louis Stokes VAMC, Cleveland, OH,(2) Associate Professor, Cleveland, OH, (3) Louis StokesCleveland Department of Vet, Cleveland, OH, (4) ClevelandVeterans Affairs Med Center, Cleveland, OH, (5) ClevelandVeterans Affairs Medical Center, Cleveland, OHIntroduction: In its 2nd year of running a specialty careaccess network (SCAN-ECHO), the Cleveland VASCAN-ECHO project is assessing the impact of thistraining on provider’s opioids prescribing practices.Methods: A core group of primary care providers (PCPs)from 13 remote outpatient clinics participated in ayear-long pilot whereby they dialed into a video-teleconference session with the pain specialty team at themain campus. The sessions included both a didactic pre-sentation given by a member of the specialty team andcase discussions of patients the PCPs would have other-wise referred to the specialty clinic at the main campus.The specialists provided recommendations to the PCPthat the PCP could then employ during their nextappointment with the patient. Success of the programwas assessed by quantifying the number of opioid anal-gesics prescriptions at each site before intervention andduring the first 6 months of years 1 and 2 post interven-tion. A significant reduction in opioids prescription indi-cates improved knowledge of multi-disciplinary painmanagement skills versus a problematic passive pattern ofopioids prescribing that is a common practice in the US.Results: Preliminary data shows that the number opioidanalgesic prescriptions significantly (p < 0.05) declined inclinics impacted by the SCAN-ECHO project. Conclu-sions: This pilot study reveals positive outcomes in termsof opioids prescribing practices. We suggest involvingPCPs in a 1-year academic project such as this. It can notonly improve their knowledge and skills but can impacttheir opioids prescribing practices. References: 1) AroraSanjeev et al. Outcomes of Treatment for Hepatitis CVirus Infection by Primary Care Providers. N ENGL JMED 364;23 June 9, 2011. 2) Arora Sanjeev et al. ProjectECHO: Linking University Specialists with rural andPrison-Based Clinicians to Improve Care for People withChronic Hepatitis C in New Mexico. Public HealthReports; 2007 supplement 2; vol 122. 3) Arora Sanjeev

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PAIN MEDICINEVolume 15 • Number 3 • 2014

© American Academy of Pain Medicine 1526-2375/15/$15.00/485 485–537 doi:10.1111/pme.12399

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et al. Academic Health Center Management ofChronic Disease through Knowledge Networks: ProjectECHO.Funding: Office of Specialty Care Transformation; VeteransAffairs Central Office

102Measurement-Based Pain Management in MilitaryHealthCare Settings: A Feasibility Study IdentifyingExisting Barriers and Charting a Course forSuccessful AdoptionLori Belford, RN, [email protected],Brian R Theodore, PhD2, Susan Chambers, BSN RN3,Gregory Bull, BS3, Teresa S Collins, CMA CCRC3,Kristin H Joltes, PA-C CCRP1, Diane M Flynn, MDCOL (Ret) MC USA4, Chester C Buckenmaier, MD5,(1) DVCIPM/Henry M Jackson Foundation, Rockville,MD, (2) University of Washington, Seattle, WA, (3) HenryM. Jackson Foundation, Dupont, WA, (4) Madigan HealthSystem, DuPont, WA, (5) Defense and Veterans Center forIntegrative Pain Management, Rockville, MDIntroduction: Pain management has been prioritized bythe Army Surgeon General’s 2010 Pain ManagementTask Force (PMTF). One of PMTF’s recommendationsis to implement a pain assessment tool and outcomesregistry. This study documents the feasibility in imple-menting a web-based patient-reported outcomes (PRO)tool in two US Military Warrior Transition Clinics(WTCs). Methods: Military IRB-approved, pre-versus-post cohort study conducted at two WTCs at Walter-Reed National Military Medical Center and MadiganHealthcare System. The study was conducted in two6-month phases, the first utilizing paper-based assess-ment of standard pain-related outcomes (Cohort 1; 445patients; 8 providers) and the second implementing aweb-based PRO tool with comprehensive outcomes rec-ommended by PMTF (Cohort 2; 246 patients; 9 provid-ers). Outcomes Included: provider satisfaction ratingswith the outcomes tool, barriers to implementation, andrecommendations for successful implementation forwider use. Results: Common themes for barriersincluded (1) institutional information technology/security considerations, (2) lack of integration with exist-ing electronic health record, (3) provider/staffcommitments to outcomes program, (4) sustainmentwithin existing clinical workflow. Each of these domainsis further detailed in Table 1, with recommendations tomitigate barriers in practice-based settings. Providerratings for satisfaction are scheduled when research iscompleted on December 2013. Conclusion: The presentstudy is a critical first step in realizing the goals of thePMTF. Identifying barriers and opportunities to imple-mentation of PRO collection as standard-of-care iscrucial in formulating a plan for future patient and pro-

vider buy-in and compliance with outcomes assessmentat every clinical encounter for pain management.Funding: Department of Defense

103Impact of Measurement-Based Care for PainManagement in Military Health Care Settings:Preliminary Results on Patient’s Perceptionof CareLori Belford, RN, [email protected], Brian R Theodore,PhD2, Susan Chambers, BSN RN3, Gregory Bull, BS4,Teresa S Collins, CMA CCRC4, Kristin H Joltes,PA-C CCRP1, Diane M Flynn, MD COL (Ret) MC USA4,Chester C Buckenmaier, MD5, (1) DVCIPM/Henry MJackson Foundation, Rockville, MD, (2) University ofWashington, Seattle, WA, (3) Madigan Health System,Dupont, WA, (4) Madigan Army Medical Center, DuPont,WA, (5) Defense and Veterans Center for Integrative PainManagement, Rockville, MDIntroduction: The Army Surgeon General’s 2010 PainManagement Task Force (PMTF) Report mandatesimplementation of a comprehensive pain outcomes assess-ment tool. This study documents patient’s satisfactionwith a web-based patient-reported outcomes (PRO) toolin two Military Warrior Transition Clinics (WTCs).Methods: Military IRB-approved, pre-versus-post studyat two WTCs at Walter-Reed National Military MedicalCenter (WR) and Madigan Healthcare System (MHS), intwo 6-month phases; the first utilizing paper-based assess-ment of standard pain-related outcomes (Cohort 1; 291WR patients; 154 MHS patients) and the secondimplementing web-based PRO’s with comprehensivepain-related outcomes recommended by PMTF (Cohort2; 166 WR patients; 80 MHS patients). OutcomesIncluded: 10-pt numeric rating scales for domains ofpatient-reported satisfaction with treatment (involve-ment, provider engagement, and overall satisfaction).Results: At post-implementation, patients at MHS per-ceived that providers better understood their concernsabout pain (p = .011), and that providers believed their“pain is real” (p = .011). In WR, following implementation,patients were less likely to perceive that providers believedtheir “pain is real” (p = .011), less likely to perceive thatproviders understood their concerns about pain (p = .005),and were less satisfied with treatment (p < .001). Explana-tory factors for these differences included demographics,deployment status, and current treatment plan. Conclu-sion: Trends in patients’ perception of value of outcomesassessment at every clinical encounter are importantmetrics in implementing PMTF recommendations. Themixed results help identify potential patient barriers toadherence, and indicate the need for strategies to mitigatethese issues before implementation as standard of care.Funding: Department of Defense

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103ARegional Anesthesia Catheters Reduce theSeverity of Neuropathic Post-Amputation Pain:Initial Results from the VIPER-80 Discovery Cohortof Injured Military PersonnelHung-Lun Hsia, [email protected],Thomas E Buchheit, MD1, Thomas Van de Ven, MD/PhD1,David Macleod, MB FRCA1, Mary McDuffie, RN BSNCCRP2, Chester C. Buckenmaier, MD2, William D White,MPH1, Andy Shaw, MB FRCA1, (1) Duke UniversityHealth System, Durham, NC, (2) Defense and VeteransCenter for Integrative Pain Management, Rockville, MDIntroduction: Post-amputation pain (PAP) is present inmore than 50% of injured military service members afteramputation and has largely been categorized as eitherphantom limb pain or residual limb pain with littledifferentiation beyond that point. In this collaborativestudy (Veterans Integrated Pain Evaluation Research(VIPER)), we further assess and explore more descriptivephenotypic classifications of PAP in the first 80 patientsenrolled in VIPER. Methods: After IRB approval, theVIPER-80 clinical cohort was assessed using well vali-dated questionnaire instruments. These questionnaireinstruments were then systematically applied as part ofthe Duke Post-Amputation Pain Algorithm (Duke-PAPA) to discriminate between distinct pain phenotypes.Using this algorithm, phantom pain was distinguished,residual limb pain (RLP) was further sub-categorizedinto: Somatic, Neuroma/Neuritis, CRPS and MosaicNeuralgia. Results: All analysis was performed by theSAS statistical analysis program. We were able to dis-criminate between multiple categories of post-amputation pain in this VIPER-80 cohort and also foundthat the overall incidence of PAP was 66% (53/80patients). S-LANSS and PTSD scores were significantlylower in subjects who received catheters versus those thatdid not. Conclusions: The incidence of chronic post-amputation pain was greater than 50% and there is sig-nificant overlap between phantom and residual limbpain. Analysis demonstrated significant differencesbetween S-LANSS and PTSD scores between groupsreceiving regional catheters for pain control versus thosethat did not. A trend towards a decreased overall inci-dence of pain in patients receiving regional catheters alsoexists. References: 1) Reiber GE, McFarland LV,Hubbard S, et al. Servicemembers and veterans withmajor traumatic limb loss from Vietnam War and OIF/OEF conflicts: survey methods, participants, andsummary findings. J Rehabil Res Dev. 2010;47(4):275–297. 2) Ephraim PL, Wegener ST, MacKenzie EJ, Dill-ingham TR, Pezzin LE. Phantom pain, residual limbpain, and back pain in amputees: results of a nationalsurvey. Arch Phys Med Rehabil. Oct 2005;86(10):1910–

1919. 3) Lindsay DR, Pyati S, Buchheit TE, Shaw A.Residual limb pain: more than a single entity? Anesthe-siology. Jan 2012;116(1):224.Funding: DOD Grant: W81XWH-11-2-0003

105Urine Drug Testing and Prescription MonitoringProgram Identify Significantly more Aberrant DrugTaking Behavior than Patients Report: Resultsfrom a Primary Care Practice Serving a LowIncome PopulationKyle Evatt, MD, [email protected],Bill McCarberg, MD2, Sarah Rosquist, MD1,Robin J Hamill-Ruth, MD3, (1) University of Virginia,Charlottesville, VA, (2) Kaiser Permanente, San Diego,CA, (1) University of Virginia, Charlottesville, VA,(3) University of Virginia Health System, Charlottesville, VAIntroduction: Primary care physicians are often reluctantto treat chronic pain patients due to the demands ofappropriate monitoring. Yet, patient report is notoriouslyinaccurate.1–7 This quality improvement project was toevaluate the utility of incorporating urine drug testing(UDT) and the prescription monitoring program report(PMP) to identify aberrant behavior. Materials andMethods: 68 community family medicine patientsagreed to participate in an IRB-approved anonymous andvoluntary QI project. The patient population was pre-dominantly low income and on Medicaid. A medicationand drug questionnaire (PQ), UDT, PMP, and medicalrecord (MR) medication list, were all de-identified andlinked by study number. Discrepancies were evaluatedbetween the data sets. Results: The average age was47.7 yr; 53% were male. The PMP showed an average of17.6 prescription (range 2–56), and 5.2 (range 1–14) pre-scribers per 12 months. Only 20% of the UDT matchedthe PMP. 30.3% of the time the UDT was positive for anillicit drug. 46.2% of those samples were adulterated vs25.4% of those with normal validity testing. PQ v UDTmatched 18.2% of the time, yet PQ matched PMP 48.4%of the time. Conclusions: UDT was the most effectiveidentifier of noncompliance. Evidence of adulteration ofthe urine sample doubles the likelihood of illicit sub-stance use. The PMP was more likely to be consistentwith patient report but was still inadequate without thecorroborating UDT results. Use of UDT and the PMPidentifies significantly more patients with aberrantdrug taking behaviors than either alone. References: 1)Webster L, Cochella S, Dasgupta N, et al. An analysis ofthe root causes for opioid-related overdose deaths in theUnited States. Pain Med 2011;12:S26–35. 2) Ready LB,Sarkis E, Turner JA. Self-reported vs. actual use of medi-cations in chronic pain patient. Pain 1982;12:285–94. 3)Fishbain DA, Cutler RB, Rosomoff HL, et al. Validity of

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self-reported drug use in chronic pain patients. Clin JPain 1999;15:184–91.Funding: None

106A New Tool for Prediction of Opioid MisuseMark L Gostine, MD, [email protected],Fred N Davis, MD1, Rebecca J Risko, BSN RN2,David Gostine, BS3, Ajay D Wasan, MD MSc4,(1) Michigan Pain Consultants, Grand Rapids, MI,(2) ProCare Systems, Grand Haven, MI,(3) Georgetown University School of Medicine, Washington,DC, (4) University of Pittsburg, Pittsburgh, PAIntroduction: We previously presented data from ourinterdisciplinary community-based pain practice on thecorrelation of the ORT with documented narcoticmisuse1. We observed the ORT sensitivity for identifyingpatients who misused opioids as 35%; therefore the goalof this project was to identify factors that would improvesensitivity and specificity. Methods: Data for 5,940patients receiving opioids who completed a pain healthassessment using IRB approved language in the consentforms were studied. Opioid misuse was defined as havingabnormal urine drug screens, problems managing opioidprescriptions, and/or poor behavior with clinic staffregarding opioid prescriptions. Using logistic regression,created a model predictive of opioid misuse in ourPRISMTM Care Management system. Results: Approxi-mately 7% of our opioid population misused their medi-cations. Identified risk characteristics included: beingmale, African American, a smoker, younger in age,insured by Medicaid, having a history of substance abuseand having multiple psychiatric diagnoses. Application ofthese factors through estimation of absolute risk usingthe logistic regression equation or risk classificationaccording to the number of risk factors present yieldedtwo scales both with sensitivities of approximately 65%.Conclusions: Our analyses have yielded two risk mea-sures with substantially higher sensitivities than weobserved with the ORT. However, the measures do notyet have clinically optimal sensitivities. Identification ofadditional risk factors is needed. Given our large patientpopulation and the high quality data of our data, furtheranalyses to identify these factors will be possible. Refer-ences: 1) Correlation of Misuse of Narcotics with thePain Health Assessment and the Opioid Risk Tool: AnAnalysis of 13,986 Patients, Gostine M, Lubinski G,Davis F, et al. 2013 AAPM annual meeting posterpresentation.Funding: None

107Outcomes Associated with Opioid UseMark L Gostine, MD, [email protected],Fred N Davis, MD1, Rebecca J Risko, BSN RN2,David Gostine, BS3, Ajay D Wasan, MD MSc4,(1) Michigan Pain Consultants, Grand Rapids, MI,(2) ProCare Systems, Grand Haven, MI,(3) Georgetown University School of Medicine, Washington,DC, (4) University of Pittsburg, Pittsburgh, PAIntroduction: The CDC has declared an epidemic ofprescription drug overdoses1. The Institute of Medicineissued a blueprint for transforming pain care in theUnited States2. To reconcile these mandates we examinedour practice outcomes to determine the impact opioidshave on chronic pain relief. Methods: Data for 2,187patients receiving opioids who completed a pain healthassessment within the PRISM Care Management Systemwere studied. IRB-approved language was in the consentforms. Opioids were delineated by schedule and then bydosage levels of no, low, moderate, high, or very highlevels of opioids. Using an ANCOVA, the following werecontrolled for: initial average pain, PAM advisor, gender,age, and length of treatment. A Tukey HSD adjustmentcontrolled for multiple comparisons. Results: Patientson opioids had significantly lower pain relief and highermean average pain levels than patients not on opioids. Inaddition, patients on opioids had significantly lowerlevels of improvement for activity, work-related activity,walking tolerance, sleep, and enjoyment of life than thosenot taking opioids. There was not a dose response curveamong opioid users. Conclusions: Our analysis showedpatients on opioids had poorer outcomes, for our selectedmeasures, when compared to patients not on opioids. Inaddition, there was no dose response curve in anymeasure for patients on opioids. Given our large patientpopulation and the high quality of our data, furtheranalyses are needed to corroborate these initial findings.References: 1) http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm. 2) http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx.Funding: None

109Trends in Benzodiazepine Prescription andCo-Prescription with Opioids in the United States,2002–2009Ming-Chih Kao, MD, [email protected],Patricia Zheng, MD2, Sean Mackey, MD PhD2,(1) Stanford University, Cupertino, CA, (2) StanfordHospital and Clinics, Palo Alto, CAIntroduction: Escalating opioid prescriptions andprescription-related deaths have drawn increasing alarm.

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However, opioids are often not the sole culprit, as morethan one type of drug is often specified as contributing tothese deaths, with benzodiazepines (BZD) as the mostfrequently cited medication. BZD prescriptions are asso-ciated with hospitalization, elderly falls, and developmentof physical and psychological dependence. Methods: Weanalyzed the National Ambulatory Medical CenterSurvey (NAMCS) to characterize the national trend ofBZD prescription by primary care physicians between2002 and 2009. We highlighted the co-prescription ratesof BZD and opioids. Variables adjusted for includeddemographics, race, ethnicity, age, gender, and payertype. Opioid and benzodiazepine coding were based ondrug class codes provided, coupled with manual review.Results: Of 3.1 billion primary care visits represented bythe survey, 12.6% involved BZD or opioid prescriptions.The BZD prescription rates increased by 12.5% per year(95% CI 9.4%–15.7%) with co-prescription increasingby 12.0% per year (95% CI 5.0%–19.4%). Opioid pre-scriptions were associated with an adjusted BZD pre-scription OR of 4.2. Conclusions: In this nationallyrepresentative study of BZD prescription, we discovereda concerning trend of increasing BZD prescriptions inprimary care offices. There was also an increase in theprevalence of co-prescription of BZD with opioids,which may be a factor contributing to rising prescriptionmedication-related deaths. Increasing rates of BZD pre-scription and co-prescriptions with opioids is an under-appreciated issue that needs to be further addressed on anational level.Funding: Redlich Pain Endowment

110Pharmacist’s Role in Human AbuseLiability StudiesJordan King, [email protected],Matthew Smollin, PharmD2, John Evans, CPhT2,Michael Smith, BS2, Lynn R Webster, MD2, (1) Sandy, UT,(2) CRI Lifetree, Salt Lake City, UTIntroduction: Human abuse liability (HAL) studiesevaluate the relative abuse potential of a medication bycomparing it with a medication that is known to beabused within the same pharmacologic class.1 The aim ofthis review is to identify and list the key responsibilities ofthe pharmacist in a HAL study. Methods: Protocols andpharmacy manuals from 6 selected HAL studies con-ducted at CRI Lifetree between September 2012 andSeptember 2013 were reviewed. Studies were selected fortheir diversity relative to route of administration, prepa-ration requirements, and depth of pharmacy involvementin pre-study feasibility work. In addition, four pharmacypersonnel were interviewed to obtain their list of keyresponsibilities for research pharmacists for a HAL study.

Results: Number of studies and routes of administrationwere 3 oral, 2 nasal, and 1 intravenous. Preparation variedby route of administration, but all studies required at leastone tampered formulation with associated blinding,documentation, and preparation procedures. Pre-studyfeasibility included 3 primary responsibility, 2 significantcontribution, and 1 minimal involvement. Feasibilitywork typically entails a blinding assessment, preparationmethodology, and pharmacy manual development. Eachroute of delivery provides unique feasibility challengesfor pharmacists. The key responsibilities outlined by thepharmacists were 1) drug labeling, storage, and account-ability; 2) blinding techniques; 3) medication preparationand, when appropriate; 4) medication administration.Conclusions: New tampering and blinding techniquesare needed to scientifically evaluate the abuse potential ofabuse-deterrent technologies in development. This willrequire increasing expertise by pharmacists knowledge-able in the objectives and conduct of HAL studies. Ref-erences: 1) U.S. Food and Drug Administration (FDA).Guidance for Industry Abuse-Deterrent Opioids-Evaluation and Labeling [draft guidance]. U.S. Depart-ment of Health and Human Services Food and DrugAdministration Center for Drug Evaluation andResearch (CDER); January 2013. 2) Vosburg SK, JonesJD, Manubay JM, et al. Assessment of a formulationdesigned to be crush-resistant in prescription opioidabusers. Drug Alcohol Depend. 2012 Nov 1;126(1-2):206–15. 3) Mastropietro DJ, Omidian H. CommercialAbuse-Deterrent Dosage Forms: Clinical Status. JDevelop Drugs. 2013 Jun 10;2(1):103.Funding: None

111Is the Constipation Problem Adequately Addressedin Patients Using Opioid and Non-OpioidMedications for Chronic Noncancer Pain?N Nick Knezevic, MD PhD, [email protected],Kenneth D Candido, MD1, Ruben Sauer, MD1,(1) Advocate Illinois Masonic Medical Center, Chicago, ILIntroduction: The purpose of this study was to analyzethe necessity of using specific questionnaires to identifyconstipation problem in chronic noncancer pain patients.Methods: After IRB approval, we included three groupsof subjects: patients regularly taking opioid medications(>30 days), patients regularly taking non-opioid medica-tions, and the general population (subjects not talkingany pain medication regularly). Results: We assessed1,661 subjects in this preliminary study and found nodifference between these groups with respect to gender,age, race, or type of pain. One hundred sixty nine out of538 patients who were taking opioids (31.4%) and only95 out of 559 patients who were taking non-opioid medi-

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cations for their chronic pain (17%) had constipation. Inthe general population, 57 out of 564 subjects (10.1%)had constipation (Figure-1). The difference in prevalenceof constipation was highly statistically significant (p <0.001), as well as the patient assessment of constipation.Patients who experienced constipation used twice asmany opioids as did patients from the same study groupwho had regular bowel movements (51.57 vs. 26.35)(Figure-2). There was a negative correlation between thenumber of bowel movements and dosage of opioids (mor-phine equivalents) (ρ = −0.288; p = 0.01). Furthermore,chart review of the same patients showed that only 32%of patients had self-reported constipation problems.Conclusion: This preliminary data showed a muchhigher prevalence of constipation in patients using opioidmedications for the treatment of chronic noncancer painthan what was self-reported, requiring us to spend moretime and use more specific targeted questions with thesepatients.Funding: None

112The Importance of Utilizing Quantitative UrineToxicology Analysis to Assist in PatientCompliance, Opioid Dose Adjustment, andUltimately Improve Pain ControlN Nick Knezevic, MD PhD, [email protected],Kenneth D Candido, MD1, Ruben Sauer, MD1,Joseph Chiweshe, MD1, (1) Advocate Illinois MasonicMedical Center, Chicago, ILIntroduction: The purpose of this study was to assesspatients’ compliance and evaluate whether repeatedquantitative urine analyses can be used as a tool toadequately control pain and adjust opioid dosage.Methods: After IRB approval, 153 patients taking opioidmedications were asked to provide supervised urinespecimens, and samples were then analyzed by Ameritox®

labs. The results were cross-referenced with the patient’smedical chart for prescribed medications and with theIllinois Prescription Monitoring Program (IPMP)seeking compliance. Results: The most common reasonfor clinic visits was low back pain (79%). Sixty-ninepercent of patients (105) were completely compliant forprescribed medications, 7 patients (4%) received con-trolled substances from another physician, 12 (8%)patients tested positive for medications that were notprescribed in clinic and that could not be verified by theIPMP, and 29 patients (19%) tested positive for illicitdrugs. Six patients tested positive for cocaine and 1 forheroin, resulting in immediate discharge, as per ouropioid agreement contingency. Most patients who testedpositive for marijuana (18) had disclosed use of marijuanafor medicinal purposes. Repeated quantitative urine toxi-

cology analyses and opioid urine concentration monitor-ing allowed enhanced adjustment of doses in 22 out of 32patients (69%), which improved pain control and com-pliance in 9 out of 12 patients (75%). Conclu-sion: Results of this pilot study demonstrated thatrepeated quantitative urine toxicology analyses could be arelevant tool to accurately adjust the dosing of opioidmedication, enhance proper management of pain, andimprove patient compliance.Funding: None

113Treating Specialty and Wait-Times DictateLong-Term Success of Spinal CordStimulation TherapyKrishna Kumar, MD, [email protected],Syed A Rizvi, MD2, (1) Regina General Hospital, Regina,SK, CAN, (2) University of Saskatchewan, Regina,Saskatchewan, CANIntroduction: Presently, the long-term success rate forspinal cord stimulation (SCS) in the treatment of chronicpain is <50%. Our data suggest that if wait-times are lessthan 2 years, the success rate of SCS soars to 75% andconversely declines to 15% if implantation delay is 20years from pain onset. SCS efficacy is inversely propor-tional to treatment delay. This study identifies barriers toimplantation and offers suggestions for improvement.Materials/Methods: A retrospective review of 443patients who received SCS was conducted. Points ofdelay from initial diagnosis and primary care and special-ist referral to implantation were examined. A two-wayANOVA was conducted that examined the effect ofgender, age, referring specialty, and their interactions onpatient pain duration. Huber’s M-estimator was used toidentify outliers. A parsimonious multiple linear regres-sion model (MLRM) using hierarchical forward searchwith switching was developed to predict pain duration atthe time of implantation. Results: From time ofsymptom onset to implantation, patients endured a meanimplantation delay of 5.12 ± 0.17 years. Initial physiciancontact occurred at a mean of 3.4 ± 0.12 months afterdevelopment of pain syndrome. Family physiciansmanaged cases for 11.9 ± 0.45 months and specialists foran additional 39.8 ± 1.22 months. Neurosurgeons werequickest to refer to a neuromodulator, whereas non-implanting anesthetists were most likely to delay implan-tation. Referral to an SCS implanter took 2.15 ± 0.35years longer if the patient was referred by a non-implanting anesthetist versus a neurosurgeon (p =0.0000). Conclusions: SCS wait-times remain a signifi-cant issue that reduces the long-term success of therapy.References: 1) Kumar K, Wilson JR. Factors affectingspinal cord stimulation outcome in chronic benign pain

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with suggestions to improve success rate. Acta NeurochirSuppl 2007;97(1):91–99. 2) Kumar K, Hunter G,Demeria D. Spinal cord stimulation in treatment ofchronic benign pain: challenges in treatment planningand present status, a 22-year experience. Neurosurgery2006;58:481–496. 3) Kumar K, Taylor RS, Jacques L,et al. Spinal cord stimulation versus conventional medicalmanagement for neuropathic pain: a multicentre ran-domised controlled trial in patients with failed backsurgery syndrome. Pain 2007;132(1-2):179–188.Funding: None

114Risk Mitigation of Prescription Opioid Misuse andActive Duty Military Personnel SuicidesSteven H Linder, MD, [email protected],Benjamin Khoo, LVN1, (1) VA Hospital, Palo Alto, CAIntroduction: Active duty military personnel (ADMP)suicides are a growing problem. Prescription opioidmisuse (POM) by ADMP is also increasing. Thesetroubles appear to be interrelated. Method: The litera-ture concerning POM and suicidal actions amongDepartment of Defense (DOD) ADMP is reviewed. Rec-ommendations to healthcare providers to improve paincare involving opioids and suicide prevention for return-ing combat veterans are summarized. Discussion: In2008, Department of Defense Suicide Event Report(DoDSER) began investigating ADMP suicides andsuicide attempts. The information indicates an associa-tion with POM. Eleven ADMP used drugs for suicide in2011. For 2011, approximately 25% of ADMP suicideshad a history of substance use disorder (SUD). A total of915 ADMP attempted suicide in 2011. Greater than halfof the suicide attempts involved prescription medication.Drug overdose was the most frequent method for suicideattempt (n = 559, 59.79%). More than 24% had a historyof SUD. In 2013, Tricare reported analgesic abuse byADMP increased sixfold from 1998 to 2003. Receipt ofpain reliever prescription was a strong predictor ofmisuse for all drugs. Absence of a drug testing programincreased risk of drug misuse. Conclusion: These find-ings suggest education is needed to identify ADMP withSUD so that providers take precautions when prescribingopioids. Means restriction activities include secure opioidstorage along with providing medication in blister pack-ages. Community-based naloxone distribution programshave the potential to reduce POM-related suicides.Suicide data are needed to make informed decisionsregarding prevention priorities. References: 1) VA/DoDClinical Practice Guidelines Assessment and Manage-ment of Patients at Risk for Suicide (Version 1.0), Assess-ment and Management of Risk for Suicide WorkingGroup, Office of Quality Safety and Value, VA, Wash-

ington, DC & Quality Management Division, UnitedStates Army MEDCOM, June 2013. 2) Gahm GA, RegerMA, Kinn JT, Luxton DD, Skopp NA, Bush NE.Addressing the surveillance goal in the National Strategyfor Suicide Prevention: the Department of DefenseSuicide Event Report. Am J Public Health. 2012 Mar;102Suppl 1:S24–8. 3) Trofimovich L, Skopp NA, LuxtonDD, Reger MA. Health care experiences prior to suicideand self-inflicted injury, active component, U.S. ArmedForces, 2001–2010. MSMR. 2012 Feb;19(2):2–6.Funding: None

115Post-Operative PACU Pain Score is Related to PostDischarge HCAHPS Scores: A RetrospectiveAnalysis of 2933 Surgical PatientsDermot Maher, MD, [email protected],Vijay Babu, MD1, Debbra Mullen, BS1, Kazu Shimasaki,MIS1, Bahman Shamloo, MD1, Charles Louy, PhD, MD1,(1) Cedars Sinai Medical Center, Los Angeles, CAHospital Consumer Assessment of Healthcare Providersand Systems (HCAHPS) is a standardized, publiclyreported survey of 27 questions of patients’ perspectivesof hospital care that are answered at the time of dis-charge1. The Affordable Care Act of 2010 includesHCAHPS as a factor in value-based incentive paymentsin the Hospital Value-Based Purchasing program. Weattempt to clarify the relationship between post-surgicalpain scores and overall patient satisfaction. Data from2933 surgical patients who were hospitalized at a singleacademic level one trauma center between March 2012and February 2013 were analyzed. The patient responsesto two questions addressing in-hospital pain managementand two questions addressing general satisfaction wereretrospectively compared to the PACU visual analogscale (VAS) pain scores. Patients were then stratifiedbased on type of surgery. For all patients undergoingsurgery, a statistically robust relationship betweenHCAHPS responses and PACU pain scores wasobserved. Subgroup analyses suggest that spine, non-spine orthopedics, and OB-GYN patients’ PACU painscores were more significantly related to HCAHPSresponses than other surgical patients’. These datasuggest that preadmission, preoperative, and intraopera-tive interventions, as well as changes in PACU patientcare, could strongly influence HACHPS scores. Refer-ences: 1) Gupta A, Daigle S, Mojica J, Hurley RW.Patient perception of pain care in hospitals in the UnitedStates. J Pain Res 2009;2:157–64.Funding: None

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116Understanding and Attitudes of Pain Medicine inThird-Year Medical Students: A Pilot Study on PainEducation CurriculumRajiv K Shah, MD, [email protected] , Neel Mehta, MD1,Dana L Gurvitch, MD1, Angela X Li, BA2, (1) WeillCornell Medical Center, Cornell University, New York, NY,(2) Weill Cornell Medical College, New York, NYIntroduction: A recent survey showed that only 3% ofmedical schools have a separate course in pain manage-ment, leaving many physicians without formal pain man-agement training.1 Formal education has been shown todecrease pain intensity among patients 35% and decreaseprescription opioid doses 3% in a large institution.2 Ourgoal was to determine the change from baseline percep-tions, attitudes, and knowledge of third-year medical stu-dents before and after a pilot course in clinical painmedicine. Material and Methods: A pilot curriculum andan evaluation were created. A 10-question pre- and post-test survey was administered. Results: In total, 108 third-year medical students participated in a 45-minuteinteractive, introductory pain medicine lecture. Seventy =two percent of students completed the pre-course surveyand 39% completed the post-course survey. Prior to thecourse, 71% of students expressed lack of confidenceprescribing pain medications including type of medica-tion and dosing, while post-test indicated 60% of stu-dents felt they “have a clear understanding of painmedication prescribing and use for [their] patients.”There was a significant increase in knowledge betweenpre- and post-tests; however, pain medication use andprescribing attitudes showed slight change. Discus-sion: The goal of the 10-question survey was to developa pain medicine curriculum for third-year medical stu-dents prior to their clinical rotations. We report anincrease in knowledge base but little change in medica-tion use and prescribing attitudes potentially showingbiases, which may be damaging to effective treatment.Formal training in pain medicine is important, yetlacking in current medical education. Further curriculumdevelopment and education projects are necessary.References: 1) Mitka M. Virtual textbook on paindeveloped: Effort seeks to remedy gap in medicaleducation. JAMA. 2003;290:2395. 2) https://www.aamc.org/newsroom/reporter/june2012/285316/pain-management.html. 3) Brennan F, Carr D, Cousins M.Pain management: A fundamental human right. AnesthAnalg. 2007;105:205–221.Funding: None

118A Call to Ears: Patient Perspectives RegardingIssues Related to Opioid PrescribingWally R Smith, MD, [email protected],Abdulkhaliq J Alsalman, MS1, Suzanne Ameringer, PhD,RN1, Jennifer K Li Wong, BS1, Maryum Ijaz, BScandidate1, (1) Virginia Commonwealth University,Richmond, VAIntroduction: Opioid prescription requires providervigilance to ensure appropriate prescription, patient vigi-lance to ensure proper use, and bilateral trust and coop-eration between prescribers and users. However, fewstudies address patients’ perspectives on how best toimprove opioid prescribing and opioid-taking behavior.The aim of this study was to determine opioid users’priorities concerning opioid prescribing and use.Methods: As part of a multiphase, mixed-methods studyusing a naturalistic, inductive reasoning approach to dis-cover resultant themes, we conducted semi-structuredinterviews of 24 patients with sickle cell disease (SCD)from various demographic backgrounds who frequentlyused opioids. We conducted multiple levels of thematicanalysis using open coding. IRB approval was obtained.Results: Patients readily offered advice for both opioidprescribers and users. Most prescriber advice targeted theemergency department, including increased sympathy,sensitivity, and trust of patients, especially patients’ painreports, when making opioid prescribing decisions.Advice to other prescribers included ensuring trust fromtheir patients, listening to pain reports; avoiding stereo-typing patients as uneducated, providing emotionalcounsel; obtaining further education about SCD, treatingpatients with respect, and helping protect patients fromthe pressure to divert medication. Advice to fellowpatients included more education about opioids, follow-ing directions, self-management, avoiding misuse, andtrusting physicians. Patients also advised increasedfederal investment in sickle cell research. Conclu-sions: Major themes of interviewed opioid users regard-ing opioid prescribing and use included trust, protection,listening, sympathy, and education. These themes offerguidance towards shaping future interventions toimprove opioid prescribing and use.Funding: None

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119National Analysis of Opioid Use Among VeteransMark Sullivan, MD PhD, [email protected],Teresa Hudson, PharmD2, Bradley C Martin, PharmDPhD2, Mark Edlund, MD PhD3, John Fortney, PhD3,Reid Landes, PhD2, Mark Austen, MS2, James S Williams,BS2, (1) University of Washington, Seattle, WA,(2) University of Arkansas Medical Sciences, Little Rock,AR, (3) Research Triangle Institute, North Little Rock, ARIntroduction: Veterans have high rates of painful condi-tions and are at risk for high rates of opioid use. Under-standing the epidemiology of opioid use is essential tominimizing risks for opioid abuse and dependence amongthis population. Methods: All veterans who received atleast two outpatient visits at a Veterans HealthcareAdministration (VHA) facility in FY 2009 and at least oneopioid prescription from the VHA were identified usingnational VHA data. Veterans who resided in a VHAnursing home or domiciliary, had a cancer diagnosis, orwho were not alive during FY 2009 and 2010 wereexcluded. We calculated rates of chronic opioid use(>90 d/yr), substance abuse disorders, and average dailydose and days’ supply for chronic and non-chronic opioidusers. Results: A total of 959,226 veterans met our inclu-sion criteria; 52.4% of opioid users use opioids chroni-cally. The average days covered among chronic opioidusers was 242.08 days compared with 29.22 days amongnon-chronic users. The mean daily dose among chronicusers was 38 mg morphine equivalent dose (MED) com-pared with 22 mg among non-chronic users. Only 5% ofpatients had a mean daily dose >90 mg MED. Substanceuse disorders were diagnosed in 23% of chronic users and20% of non-chronic users. Among non-chronic users inFY 2009, 16.6% used opioids chronically in FY 2010.Conclusions: Chronic opioid use is very common amongveterans, but mean doses are modest. In contrast to othersamples, no increase in rates of chronic opioid use werefound in those with diagnosed substance use disorders.References: 1) Edlund MJ, Fan MY, DeVries A, BradenJB, Martin BC Sullivan MD. Trends in use of opioids forchronic non-cancer pain among individuals with mentalhealth and substance use disorders: the TROUP study.Clin J Pain 2010; 26:1–8. 2) Weisner C, Campbell CI,Ray GT, Saunders K, Boudreau D, Sullivan MD, MerrillJO, Silverberg MJ, Banta-Green C, Von Korff M, Trendsin prescribed opioid therapy for non-cancer pain for indi-viduals with prior substance use disorders. Pain, 2009;145:287–93. 3) Edlund MJ, Fan MY, DeVries A, BradenJB, Martin BC Sullivan MD, An analysis of heavy utiliz-ers of opioids for chronic non-cancer pain in theTROUP Study. J Pain Sympt Mgmt, 2010, 40:279–89.Funding: National Institute on Drug Abuse

120National Study of Discontinuation of ChronicOpioid Therapy Among VeteransMark Sullivan, MD PhD, [email protected],Erik Vanderlip, MD1, Teresa Hudson, PharmD2,Mark Edlund, MD PhD3, Bradley C Martin, PharmDPhD2, John Fortney, PhD3, Reid Landes, PhD2,Mark Austen, MS2, James S Williams, BS2,(1) University of Washington, Seattle, WA, (2) Universityof Arkansas Medical Sciences, Little Rock, AR,(3) Research Triangle InstituteIntroduction: Veterans have high rates of painful con-ditions and show high rates of chronic opioid use(>90 d/yr). In past studies, chronic opioid discontinua-tion was less likely in those receiving high daily opioiddose and in those showing evidence of opioid misuse.Understanding rates and predictors of discontinuationwill clarify the risks for opioid abuse and dependenceamong this population. Methods: All veterans whoreceived at least two outpatient visits at a VeteransHealthcare Administration (VHA) facility in FY2009and at least 90 days of opioid use within a 180-dayperiod were identified using national VHA data. Veter-ans who resided in a VHA nursing home or domiciliary,had a cancer diagnosis, or who were not alive during FY2009 and 2010 were excluded. Opioid discontinuationwas defined as 6 months with no opioid prescriptions.We utilized Cox proportional hazards analysis to calcu-late rates opioid discontinuation and determine risks foropioid discontinuation. Results: A total of 959,226 Vet-erans received an opioid prescription. 52.4% of these(502,634) used opioids chronically. We will examinedemographic, clinical (pain characteristics, medical,mental health, substance abuse diagnoses), and treat-ment (opioid and non-opioid analgesics, other psycho-tropics, non-medication pain treatments) characteristicsas predictors of opioid discontinuation. Conclu-sions: Discontinuation of chronic opioid use is animportant determinant of the overall prevalence ofopioid use. Complete survival analyses providing detailson rates and predictors will be presented at the meeting.References: 1) Martin BC, Fan MY, Edlund MJ,DeVries A, Braden JB, Sullivan MD, Long TermChronic Opioid Therapy Discontinuation Rates FromThe TROUP Study, J Gen Intern Med, 2011;26:1450–7. 2) Gore M, Sadosky A, Leslie D, Tai KS,Seleznick M. Patterns of therapy witching, augmenta-tion, and discontinuation after initiation of treatmentwith select medications in patients with osteoarthritis.Clin Ther. 2011Dec;33(12):1914–31. 3) Noble M,Treadwell JR, Tregear SJ, Coates VH, Wiffen PJ,Akafomo C, Schoelles KM. Long-term opioid manage-ment for chronic noncancer pain. Cochrane Database

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Syst Rev. 2010 Jan 20;(1):CD006605. doi: 10.1002/14651858.CD006605.pub2.Funding: National Institute on Drug Abuse

121OMERACT-Based Fibromyalgia SymptomSubgroups: An Exploratory Cluster AnalysisAnn Vincent, MBBS MD, [email protected],Tanya Hoskin, MS1, Dan Clauw, MD2, Debra Barton,PhD RN2, Roberto Benzo, MD2, David A Williams, PhD2,(1) Mayo Clinic, Rochester, MN, (2) University ofMichigan, Ann Arbor, MIIntroduction: Fibromyalgia’s heterogeneous clinicalpresentation makes uniform treatment recommendationschallenging. No previous study has identified subgroupsof patients based on core symptom domains recom-mended by the Outcome Measures in Rheumatology(OMERACT) fibromyalgia working group. We identi-fied subsets of patients with fibromyalgia with similarsymptom profiles using core OMERACT symptomdomains. Methods: Female patients with a diagnosisof fibromyalgia meeting Fibromyalgia Research SurveyCriteria completed the Brief Pain Inventory, 30-itemProfile of Mood States, Medical Outcomes SleepScale, Multidimensional Fatigue Inventory, MultipleAbility Self-Report Questionnaire, Fibromyalgia ImpactQuestionnaire-Revised, and Medical Outcomes ShortForm-36. Hierarchical agglomerative clustering was usedto identify subgroups of patients with similar symptomprofiles. This study was approved by the Mayo ClinicIRB. Results: 581 females with a mean age of 55.1 (range20.1–90.2) years were included. A four-cluster solutionbest fit the data, and each clustering variable differedsignificantly (p < 0.0001) among the four clusters. Thefour clusters divided the sample into severity levels:Cluster 1 reflects the lowest average levels across allsymptoms, Cluster 4 reflects the highest average levels,and Clusters 2 and 3 capture moderate symptoms levels.Clusters 2 and 3 differed mainly on profiles of the mentalaspects of the disease, with Cluster 2 having lower levelsof depression, anxiety, and dyscognition and somewhathigher levels of pain, stiffness, dysfunction, sleep distur-bance, and fatigue than Cluster 3. Conclusions: Ourstudy is the first cluster analysis to incorporate coreOMERACT symptom domains. This approach could beuseful in directing individualized therapy for patientswith fibromyalgia.Funding: This study was supported in part by the Center forTranslational Science Activities (CTSA) at Mayo Clinic.This center is funded in part by a grant from the NationalCenter for Research Resources (NCRR), a component of theNational Institutes of Health (NIH) (RR024150). Its con-tents are solely the responsibility of the authors and do not

necessarily represent the official view of CTSA, NCRR, orNIH.

122Insurance Prior-Authorization Processfor Interventional Pain Procedures:A Community-Teaching Hospital ExperienceTonhu Vu, MD, [email protected], Suzanne Bock, BA2,Lari L Dean, POA1, Alison Liu2, Rod Grim, MA3,(1) Wellspan Interventional Pain Management, York, PA,(2) York Hospital, York, PA, (3) Wellspan Health, York, PABackground: Insurance prior-authorization for interven-tional pain procedures is a time-consuming, costlyprocess that lacks standard, transparent regulations. TheAMA has estimated that 10%–14% of practice revenue isconsumed by claims management administration. Studyobjectives were to assess average prior-authorization timeand determine if diagnostic procedures and/or treatmentregimens were required by insurers before seeking priorauthorization. Methods: Data on 167 consecutive prior-authorizations were collected from 5/20/13 to 6/14/13.Prior-authorization time in minutes included phone con-versations, document verification and form completion.Patient data included demographics, insurance provider,procedure CPT, diagnostic ICD codes, outcome painscores, and additional services received. Results: Patientswere predominantly women (61.4%), white (92.2%),married (59.0%), and employed (43.4%). Of the seveninsurance plans represented, five accounted for 93.3% ofthe cases. The average prior-authorization time across allplans was 14.9 minutes (SD = 18.9) with individual planaverage times ranging from 3.3 to 25.6 minutes. Byprocedure, average prior-authorization times rangedfrom 5.6 minutes (cervical facet) to 35.9 (spinal cordstimulator). The specific diagnostic/treatment regimensrequired before seeking prior-authorization were: medi-cation, imaging, physical therapy, and durable medicalequipment. However, these were not standardized acrossinsurers; two insurers required 3 tests/ treatments,while 1 insurer had no requirements. Conclusions: Theaverage 15 minutes spent on prior authorization for eachinterventional pain procedure translates to 41.75 staffhours for 167 patients; this may reduce patient care timewhile increasing costs. The lack of standardizationrequirements across insurers may delay patients fromreceiving optimal care. References: 1) AmericanMedical Association. (2011). Standardization of priorauthorization process for medical services white paper.Available online: http://www.amaassn.org/resources/doc/psa/standardization-prior-auth-whitepaper.pdf.Funding: None

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124Estimating the Need for Magnetic ResonanceImaging (MRI) in Patients with Spinal CordStimulation (SCS)Mehul J Desai, MD MPH, [email protected],Michael Ryan, MS2, Liesl M Hargens, MPH3,Alissa H Doth, BS3, (1) George Washington University,Washington, DC, (2) Statistical Solutions, Cincinnati, OH,(3) Medtronic, Minneapolis, MNIntroduction: Patients with conventional SCS systemshave not traditionally had access to needed MRIs. Thisanalysis estimates MRI need in the SCS-implanted popu-lation. Methods: The Truven Health MarketScan Com-mercial Claims and Medicare Supplemental databaseswere used to identify patients with a diagnosis code froman inpatient or outpatient claim in 2008–2011 designat-ing chronic back and leg pain (n = 5,751,174). Patientswith a claim for a cardiac implant and, therefore, contra-indicated for MRI were excluded (N = 117,366). Remain-ing patients were separated into two groups: those havinga claim with a procedure code for SCS (SCS-implanted, n= 13,995) and those who did not (SCS-indicated, n =5,619,813). SCS-indicated patients continuously enrolledfor 4 years were matched by age, gender, and a comorbidconditions propensity score to SCS-implanted patients (n= 3,414). A Kaplan Meier survival curve of time to firstMRI was computed and extrapolated to 5 years.Results: There were 3,414 matched SCS-indicatedpatients tracked for 4 years. The survival curve estimatedthe proportion of patients needing MRI after 1 year(52%), 2 years (64%), 3 years (72%), or 4 years (78%).Conservatively assuming an average SCS device life withrechargeable and primary cell batteries of 5 years, theestimated need for MRI over the life of a device is 89%.Conclusions: Using a propensity-matched populationcohort to the SCS-implanted patients, approximately89% of patients were estimated to need at least one MRIduring the life of an SCS device. This analysis highlightsa need for MRI-conditional SCS devices that will grantSCS patients access to this imaging modality.Funding: This study is supported by Medtronic Inc.

Procedures

125Patient Preference of Manufacturer Features forSpinal Cord StimulationMohammed A Issa, MD, [email protected],Chong H Kim, MD1, Christina Julian, MD1, (1) WestVirginia University, Morgantown, WVObjective: Currently, three manufacturer devices arecommercially available for patients to consider for SpinalCord Stimulation. Each device manufacturer offers spe-cific features unique to each company. The three most

common features were remote control capability, MRIcompatibility, and position-adaptive sensor control. Thisstudy evaluates and compares the subject preferences ofthe available features. Design: Simple cohort designstudy. Setting: The study was performed at an academicuniversity pain management center. Subjects: A total of37 subjects were provided information regarding theavailable SCS devices from January until December 2012.21 subjects were females and 16 were males. Basic demo-graphic characteristics are shown in table 1. Interven-tions: After agreeing to receive a Spinal Cord Stimulator(SCS), all subjects reviewed the three manufacturer-provided DVDs in the same order and questions wereaddressed by the treating physician. After selecting anSCS, they were asked to convey their reasons for theirchoice. Results: 11 subjects selected remote capability,10 selected MRI safety, and 7 selected the position-adaptive sensor control feature. The remaining 9 subjectsgave other reasons for their SCS selection. Mean age forthe sensor control group was 52 as compared to 69 forremote capability and 66 for MRI safety (differences werestatistically significant). Female subjects preferred MRIcompatibility and sensor control features. Conclu-sion: Remote control capability and MRI safety were themost common preferred features. Younger subjects’ pref-erence for sensor control feature maybe related to theirincreased activity and thus, their preference for an auto-matically responsive device. References: 1) Kumar K,Abbas M, Rizvi S. The use of spinal cord stimulation inpain management. Pain Management 2012; 2(2): 125–134. 2) Williams KA, McLeod JC, Reinhardt G. Howprocess analysis could improve the implementation ofspinal cord stimulation treatment for chronic pain. PainManagement 2012; 2(3): 251–258. 3) Mailis-Gagnon A,Furlan AD, Sandoval JA, Taylor R. Spinal cord stimula-tion for chronic pain. Cochrane Database Syst Rev. 2004;(3): CD003783.Funding: None

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126Comparison of Two Ultrasound-Guided Techniquesfor Administration of Steroids Around the GreaterOccipital Nerve Injection for Treatment ofRefractory Primary Headache SyndromeHusni Alakkad, MD, [email protected],Anuj Bhatia, MBBS MD DNB FRCA MNAMS FIPPFRCPC2, Philip WH Peng, MD1, Allan Gordon, MBBSMD FRCPC3, (1) University of Toronto, Toronto, Ontario,CAN, (2) University of Toronto and University HealthNetwork-TWH, Toronto, ON, CAN, (3) Mt. SinaiHospital - Wasser Pain Management Center, Toronto, ON,CANIntroduction: Two ultrasound (US)-guided techniquesfor greater occipital nerve (GON) block have beendescribed for the management of refractory headachesyndromes1: a proximal technique performed at the levelof the second cervical vertebra2 and a distal techniqueperformed at the level of the superior nuchal line3. Weconducted a double-blinded, randomized control trial tocompare accuracy, efficacy, and safety of these two tech-niques in patients with refractory headache syndromes.Materials and Methods: Following REB approval, 40patients with moderate or severe refractory headaches(intensity score >4/10) have been randomized to the“proximal” or “distal” groups with a 1:1 allocation. Eachpatient receives an injection of 2 ml of 0.5% bupivacainewith 40 mg of methylprednisolone. The null hypothesisis that there is no difference in intensity scores for head-ache at 1 month after the interventions. Outcomesrelated to efficacy (numbness immediately after the injec-tion, reduction in episodes of severe headache, sleepquality), performance (time taken for and discomfortduring procedure), and safety (incidence of hematoma,intravascular injection) are measured. Results: Data arebeing tabulated and analyzed. Final results and conclu-sions will be presented during the conference. Refer-ences: 1) Afridi SK, Shields KG, Bhola R, Goadsby PJ.Greater occipital nerve injection in primary headachesyndromes - prolonged effects from a single injection.Pain. 2006; 122: 126–9. 2) Greher M, Moriggl B, Cura-tolo M, Kirchmair L, Eichenberger U. Sonographic visu-alization and ultrasound-guided blockade of the greateroccipital nerve: a comparison of two selective techniquesconfirmed by anatomical dissection. Br J Anaesth 2010;104: 637–42. 3) Shim JH, Ko SY, Bang MR, Jeon WJ,Cho SY, Yeom JH, Shin WJ, Kim KH, Shim JC.Ultrasound-guided greater occipital nerve block forpatients with occipital headache and short term followup. Korean J Anesthesiol. 2011 Jul;61(1):50–4. doi:10.4097/kjae.2011.61.1.50. Epub 2011 Jul 21.Funding: None

127Endocrine Dysfunction with Intrathecal OpioidsChong H Kim, MD, [email protected],Monica Ata, DO1, (1) West Virginia University,Morgantown, WVIntroduction: Intrathecal drug delivery is an effectiveand efficient alternative in administration of opioids.1–2

Initially used for intractable cancer pain, intrathecalopioid administration of opioids has been increasinglyutilized more recently for nonmalignant chronic pain inpatients who failed conventional treatment or could nottolerate traditional therapy due to side effects.3–4 Withthe ability to deliver analgesia into the cerebral spinalfluid within close proximity to the receptors within thespinal cord, analgesia can be obtained with sufficientcomparable pain control with minimal side effects causedby systemic opioids at significant lower doses.5–9 Mor-phine is the only FDA-approved opioid for intrathecaladministration. However, opioids, independently or incombination with local anesthetics, are now used. IDD iseffective, inexpensive, and well-tolerated overall.However, side effects do exist.10 One such possible area ofconcern is endocrine dysfunction. Methods: Twentyconsecutive patients, 10 male and 10 female, werescreened via questionnaire. Patients complaining ofdecreased libido, mood, and fatigue were screened forendocrine dysfunction, including serum testosterone andfree testosterone. Results: Of the twenty patientsscreened, 17 patients showed endocrine dysfunction.Three patients had normal blood work. Sixteen patientswere on a single opioid regimen, 3 with opioid and anes-thetic and 1 with opioid and clonidine. All 3 patients withnormal blood work were males and were on opioid withanesthetic intrathecal regimen. Conclusion: In intrathe-cal opioid administration, anesthetics when used in con-junction with opioids may serve a potential protectiverole. References: 1) Payne R. Role of epidural and intra-thecal narcotics and peptide in the management of cancerpain. 1987; 71:313–327. 2) Portenoy RK, Seddon RS.Clinical realities and economic considerations: specialtherapeutic issues in intrathecal therapy–tolerance andaddiction. J Pain Symptom Manage. 1997; 14:S27–S35.3) Shug SA, Zech D, Ground S. Adverse effects of sys-temic opioid analgesic. Drug Safety. 1992; 7:200–213.Funding: None

128A Prospective Randomized Double-Blind Trial onthe Efficacy of TAP Block in Post C-SectionPatients when Compared to PlaceboPradeep Balasubramaniam, MD, [email protected],(1) New York Methodist Hospital, Brooklyn, NYIntroduction: The aim of our study was to investigatewhether a transversus abdominis plane (TAP) block using

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either 0.25% or 0.5% bupivacaine confers additionalanalgesia for post c-section patients when compared toplacebo. Materials and Method: Sixty patients undergo-ing elective C-section under combined spinal epiduralanesthesia were enrolled and randomized into 3 groups.All groups received 3 mg epidural morphine after deliv-ery and on-demand only IV PCA morphine postopera-tively. A TAP block was performed postoperatively using15 ml of 0.5% bupivacaine (group 1), 15 ml of 0.25%bupivacaine (group 2), or 15 ml of normal saline (group3). Pain and other associated scores were assessed at 0, 3,6, 24, and 48 hours postoperatively. Results: The painscores at 3, 6, 24, and 48 hours were significantly lower inboth bupivacaine groups compared to the placebo group(p-value ranging from 0.0011 to 0.0409). The number ofPCA boluses used within 3, 6, 24, and 48 hours weresignificantly lower in both bupivacaine groups comparedto the placebo group (p-value ranging from 0.0054 to0.0382). Satisfaction after 24 and 48 hours was signifi-cantly higher between the bupivacaine groups comparedto the placebo group (p-values ranging from 0.008 to0.023). There were no significant differences between thebupivacaine groups. Also, no significant differences werenoted in nausea, itching, ability to walk, ability to toleratefood, and discharge criteria between the three groups.Conclusion: In this trial, supplementary TAP block wasassociated with reduced pain scores, decreased IV PCArequirements, and greater satisfaction than placebo. Ref-erences: 1) Baaj JM, Alsatli RA, et al, Efficacy ofultrasound-guided transversus abdominis plane (TAP)block for postcesarean section delivery analgesia- adouble blind, placebo-controlled, randomized study.Middle East Journal of Anesthesiology 2010, 20(6):821–826. 2) D. Belavy, P.J. Cowlishaw et al. Ultrasound-guided transversus abdominis plane block for analgesiaafter Cesarean delivery. Br.J. Anaesth 2009; 103(5): 726–730. 3) John G McDonnell, Brian O Donnell, et al. Theanalgesic efficacy of transversus abdominis plane blockafter abdominal surgery: A prospective randomized con-trolled trial. Anesth Analg 2007; 104:193–7.Funding: None

130Transforaminal Versus Interlaminar Approaches toEpidural Steroid Injections: A Systematic Reviewof Comparative Studies for LumbosacralRadicular PainGeorge Chang Chien, DO, [email protected],Zack McCormick, MD1, Samuel K Chu, MD1,Andrea M Trescot, MD2, Kenneth D Candido, MD3,(1) Rehabilitation Institute of Chicago, Chicago, IL,(2) Pain and Headache Center, St Augustine, FL,(3) Advocate Illinois Masonic Medical Center, Chicago, ILBackground: The superiority of transforaminal epiduralsteroid injections (TFESI) vs. interlaminar epiduralsteroid injections (ILESI) for treating unilateral lumbo-sacral radicular pain (ULSRP) is unproven. Objec-tive: To assess studies comparing TFESI to ILESI forULSRP for pain relief and functional improvement.Methods: A systematic literature search was conductedusing the Cochrane Central Register of ControlledTrials, PubMed, and Scopus databases for trials reportedin English. Studies meeting the Cochrane Review criteriafor randomized trials and the AHCQ criteria for obser-vational studies were included. Evidence was gradedusing the USPSTF classification. Clinical significancewas defined as pain reduction ≥20% and functional scoreimprovements ≥10%. Statistical analysis was performedon prospective studies. Results: Five (prospective) andthree (retrospective) studies were included assessing 506patients. Approximately 49% (249) were followed-up anaverage of 3.2 months. For short-term (2 weeks) painrelief, there was a 15% difference favoring TFESI vs.ILESI. There was no efficacy difference at 1 or 6 months.Combined pain improvements in all five prospectivestudies revealed <20% difference between TFESI andILESI (54.1% vs. 42.7%). There was slightly better func-tional improvement in ILESI groups (56.4%) vs. TFESIgroups (49.4%) at 2 weeks. Combined data showed slightdifferences (TFESI 40.1% and ILESI 44.8%). Conclu-sions: The findings show that both TFESI and ILESIare effective in reducing pain and improving functionalscores in ULSRP. TFESI demonstrated nonclinically sig-nificant superiority to ILESI for short-term (2 weeks)pain relief. Based on 2 studies, ILESI demonstrated non-clinically significant superiority to TFESI in functionalimprovement. References: 1) Manchikanti L, Pampati V,Falco FJE, Hirsch JA. Assessment of the growth of epi-dural injections in the Medicare population from 2000 to2011. Pain Physician 2013; 16:E349–64. 2) Chang ChienGC, Candido KD, Knezevic NN. Digital subtractionangiography does not reliably prevent paraplegia associ-ated with lumbar transforaminal epidural steroid injec-tion. Pain Physician 2012; 15: 515–23. 3) Candido KD,Raghavendra MS, Chinthagada M, Badiee S, Trepashko

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DW. A prospective evaluation of iodinated contrast flowpatterns with fluoroscopically guided lumbar epiduralsteroid injections: the lateral parasagittal interlaminarepidural approach versus the transforaminal epiduralapproach. Anesth Analg 2008; 106: 638–44.Funding: None

131Ultrasound Guidance for Intrathecal Pump RefillGeorge Chang Chien, DO, [email protected],Prin Amorapanth, MD PhD1, Christopher D Reger, MD1,(1) Rehabilitation Institute of Chicago, Chicago, ILIntroduction: Many factors can increase the difficulty ofrefilling intrathecal drug pumps. Excess subcutaneous fat,spasticity, sub-optimal positioning, pump rotation, andscar formation over the reservoir filling port (RFP) cancreate challenges during pump refill. As a result, multipleunsuccessful attempts at accessing the RFP can bepainful, increase spasticity, and increase the risk of infec-tion. Here we investigate the use of ultrasound guidanceduring baclofen pump refill. Methods: We report a caseseries of eight ITB pump refills utilizing ultrasound guid-ance. Patients were enrolled during routine intervalrefills. A Biosound ultrasound machine was utilized toidentify the RFP. The site was marked under direct visu-alization with a retracted pen. This site was comparedwith the estimated location according to the manufactur-ers refill template. Results: The RFP is distinctly visual-ized on ultrasound. Seven of eight ultrasound-guidedmarkings showed concordance with the refill template,and these pumps were accessed on one attempt. Mis-match was found for one pump that was greatly rotated.Although the RFP was easily identified in this case, weattribute failure to access on one attempt to changes inthe positioning of the pump between localization andport access. Conclusions: Localization of the RFP byultrasonography is feasible and easy. Ultrasound affordsthe advantages of portability, lack of radiation, anddynamic real-time imaging. In lieu of locating the RFPprior to needle insertion, direct visualization and accessof the RFP under ultrasound should greatly increase therate of success. References: 1) Gofeld M, McQueen CK.Ultrasound-guided intrathecal pump access and preven-tion of the pocket fill. Pain Med. 2011 Apr;12(4):607–11.2) Shankar H. Ultrasound-Guided Localization ofDifficult-to-Access Refill Port of the Intrathecal PumpReservoir. Neuromodulation. 2009 Jul;12(3):215–8.Funding: None

132Spinal Anesthesia for Placement of Surgical SpinalCord Stimulation Paddle Electrodes: A Case SeriesConnor Clark, [email protected],William S Rosenberg, MD2, (1) Parkville, MO,(2) Midwest Neurosurgical Associates, Kansas City, MOIntroduction: The optimal technique for placement ofspinal cord stimulation (SCS) paddle electrodes has yet tobe determined, although precise patient reporting of par-esthetic coverage, if achievable, is most reliable. Local/MAC anesthesia and EMG monitoring under generalanesthesia have both been suggested but have theirrespective drawbacks. The authors present anotheroption–a completely awake patient under spinalanesthesia–for the accurate and efficient placement ofpaddle electrodes. Methods: Retrospective analysis wasperformed on 128 consecutive cases of surgical paddleleads placed in awake patients under spinal anesthesiafrom June 2010 to March 2013. The paddle leads wereplaced via laminotomy and paresthetic coverage opti-mized using patient report intraoperatively. Confirma-tion of paresthesia overlaying the entire painful regionwas received before closure. Results: In one case (0.8%),no paresthesia could be felt, secondary to nerve rootrather than SCS. In another case, the patient was unableto report stimulation because of oversedation, althoughimplantation was successful. In 125 cases (97.7%), intra-operative feedback was used successfully in implantationand in an additional case was used to exclude placementbased on neurophysiology. In one case, postoperativestimulation varied from intraoperative sensation, requir-ing repositioning of the paddle. In the remaining 124cases, postoperative stimulation was identical, althoughoften requiring slightly less power. There were noinstances of cardiopulmonary or other complicationrelated to spinal anesthesia. Conclusions: Spinal anes-thesia is safe and effective for placement of SCS paddleelectrodes, with an advantage of the precise reporting ofa completely awake patient. References: 1) Falowski,S M, Celii, A, Sestokas, A K, Schwartz, D M, Matsumoto,C, & Sharan, A. (2011). Awake vs. asleep placement ofspinal cord stimulators: a cohort analysis of complicationsassociated with placement. Neuromodulation, 14(2),130–4; discussion 134. 2) Garcia-Perez, ML, Badenes, R,Garcia-March, G, Bordes, V, & Belda, FJ (2007). Epi-dural anesthesia for laminectomy lead placement in spinalcord stimulation. Anesth Analg, 105(5), 1458–61. 3)Lind, G, Meyerson, BA, Winter, J, & Linderoth, B.(2003). Implantation of laminotomy electrodes for spinalcord stimulation in spinal anesthesia with intraoperativedorsal column activation. Neurosurgery, 53(5), 1150–3;discussion 1153.Funding: None

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133Is the Lateral Jack-Knife Position Responsible forCases of Transient Neuropraxia?Timothy T Davis, MD, [email protected],Daniel Fung, MD2, Diana M Molinares, MD2,(1) Center For Spine & Joint Restoration, Santa Monica,CA, (2) Los Angeles, CAIntroduction: Nerve root and/or peripheral nervestretching in the lateral jack-knife position could contrib-ute to the postoperative neurologic deficits. Objec-tive: The objective of this study is to assess what impactthe lateral jack-knife surgical position has in the develop-ment of postoperative transient neuropraxia. Materialsand Methods: Twenty volunteers were randomlyassigned to one of two study groups: right lateral decu-bitus (RLD) position and 25 degree right lateral jack-knife (RLJK) position. Prepositioning hip flexion andknee extension strength and sensory testing was per-formed. Subjects were placed in the assigned surgicalposition for 60 minutes. The same strength tests wereperformed immediately after positioning and 60 minutesafter, and sensory testing was performed every 15 minutesfor 1 hour. Results: Left-sided neurologic deficits wereobserved in all RLJK subjects and not in the RLD group.Statistically significant differences (p-value < 0.05) werefound with strength testing. Abnormal left lower extrem-ity sensory scores were observed in all subjects inthe RLJK group, with L1 and L2 being the mostaffected dermatomes (pinprick p = 0.00001, light touchp = 0.0007). Conclusion: Transient neuropraxia wasobserved in 100% of the subjects in the 25 degrees RLJKposition group. No neurologic deficits were observed inany of the subjects in the right lateral decubitus positiongroup. Our results lead to the conclusion that the lateraljack-knife position alone can contribute to some of thepostoperative neurologic symptoms observed in patientspositioned in this position. References: 1) Shen FH,Samartizis D, Khanna AJ, Anderson DG. Minimallyinvasive techniques for lumbar interbody fusions. OrthopClin N Am 2007; 38:373–386. 2) Moller DJ, Slimack NP,Acosta FL, Koski TR, Fessler RG, Liu JC. Minimallyinvasive lateral lumbar interbody fusion and transpsoasapproach-related morbidity. Neurosurg Focus 2011;31(4):E4 1–5. 3) TT. Davis, MD.; HW. Bae, MD.; MAJJM. Mok, MD.; MC, USA, A. Rasouli, MD.; R.B.Delamarter, MD. Lumbar Plexus Anatomy within thePsoas Muscle: Implications for the Transpsoas LateralApproach to the L4-L5 Disc.Funding: None

134Safety and Efficacy Outcomes of StimRouter™—a Novel New Neuromodulation SystemTina Garten, [email protected], Timothy R Deer, MD1,(1) Center for Pain Relief, Charleston, WVIntroduction: Chronic neuropathic pain attributed tosingle peripheral nerve trauma occurs in a subgroup ofthe overall neuropathic pain population, estimated atapproximately 10% of adults. For patients refractive topharmacotherapy, both non-invasive and invasive neuro-modulation are viable treatment options. Although nervestimulation choices vary, peripheral nerve stimulation(PNS) provides a more targeted alternative when treatingpain associated with a single nerve. Study Materials andMethods: Ninety patients implanted with StimRouter™,randomized to PNS (treatment) or placebo stimulation(control) were followed for 90 days. Patient and observerwere blinded to treatment assignment. Average proce-dure time was approximately 30 minutes, requiring onlylocal anesthesia. Wound closure was achieved primarilyusing sterile adhesive strips. All implants were outpatientprocedures. Pain was measured at baseline and 90 dayspost-randomization using Pain Inventory Short Form(BPI SF #5). Patients were enrolled under an IRB-approved protocol (ClinicalTrials.gov Identifier:NCT01592344). Results: After 3 months of StimRouterimplantation with no increase in pain medications, thetreatment group achieved significantly greater painreduction, having three times more responders (>30%pain reduction) than the control group. No seriousadverse events were reported. Minor complicationsincluded rash and/or itching at stimulation site andwound site soreness. Conclusions: Patients with severeintractable chronic pain of single peripheral nerve originassociated with post-traumatic/post-surgical neuralgiacan benefit from StimRouter implantation. In this study,the procedure proved safe, only minor complicationsreported. Furthermore, the majority of patients werecompletely satisfied with StimRouter treatment. Refer-ences: 1) B. Yawn, P. Wollan, T. Weingarten, J. Watson,WM Hooten, L. Melton. The prevalence of neuropathicpain: Clinical evaluation compared with screeningtools in a community population. Pain Med 2009:10(3):586–93.Funding: None

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135Pain After Total Knee Arthroplasty and SpinalFusion: A Comparison of Two AnestheticParadigms via a Social Network Analysis ofPerioperative TeamsPatrick J Tighe, MD, [email protected],Catherine Dietrich, 2nd Year Medical Student1,Russell Bernard, PhD1, Roger Fillingim, PhD1,(1) University of Florida, Gainesville, FLTo study the relationship between postoperative painoutcomes and perioperative teams under varied anes-thetic paradigms, we utilized social network analysis tovisualize and quantify links (connections) between nodes(subjects). We hypothesized that spinal fusions would bemore sensitive to intraoperative decisions due to theabsence of preoperative anesthetic procedures like anerve block, which precedes total knee arthroplasties. Inthis study, we constructed a separate network for eachprocedure, which included the surgeons, anesthesiolo-gists, and circulating nurses as nodes linked by the casesthey worked together. We normalized the links toaccount for the variation in the proportion of cases withsevere pain outcomes among different teams. We calcu-lated the degree centrality values (measures of how con-nected a node is) of the team members, correlated themwith the cases, and then examined correlations betweenteam member descriptors and pain outcomes. Severe painevents after spinal fusion cases correlated more stronglyto the degree centrality values of the surgeons and anes-thesiologists than to total knee arthroplasty procedures,where the centrality values of the surgeons showed astronger correlation than those of the anesthesiologists.The more connected the individual, the lower the likeli-hood of an associated severe pain event. The difference inthe strength of correlation between the centralities andidentities of the surgeons and anesthesiologists in thetotal knee arthroplasty network versus the spinal fusiongroup may be due to the difference in anestheticapproaches used for these types of surgery.Funding: None

136Blood Patching for Post Dural Puncture Headacheafter Intrathecal Drug Delivery SystemImplantation: A Technical Report andRetrospective Case SeriesEugerie Douge, MD, [email protected],Rebecca Adair, MD2, Bryan C Hoelzer, MD2, Wenchun Qu,MD PhD2, Jason S Eldrige, MD2, Stephanie A Neuman,MD3, Susan Moeschler, MD3, (1) Mayo Clinic, Rochester,MN, (2) Mayo Clinic Rochester, Rochester, MN,(3) Gundersen Health System, La Crosse, WIIntroduction: Post Dural Puncture headache (PDPH) is aknown complication of intrathecal drug delivery system

(IDDS) implantation. A recent study indicated the rate ofPDPH may be as high as 23%. Conservative treatment istypically adequate for symptom resolution. However, forresistant PDPH there is some controversy on the besttreatment course. Epidural blood patches (EBP) may berisky in the post-implant period secondary to chance ofinfection, wound complications, and catheter displace-ment. We present a case series of 14 patients describingour method for blood patching after failed conservativetherapy. Materials and Methods: With IRB approval, aretrospective chart review was performed of all IDDSplaced in our institution over the past 20 years. Patientswith PDPH were identified and treatments wererecorded. Of 73 patients that developed PDPH, 15 failedconservative management options, resulting in the needfor EBP. In 13 patients, the epidural space was accessed1–4 levels below the catheter entry site. One EBP wasdone at the catheter entry level. Details of one procedurewere not recorded. An average of 20cc of blood was used.Results: In each patient, the PDPH resolved with EBP;however, two patients required a repeat blood patch forresolution. No complications were noted. Conclu-sions: EBP after IDDS is often avoided due to concern forsignificant problems. We have observed, however, thatpatients tolerate this procedure well without short- orlong term complications. This is a reasonable interventionfor patient with PDPH and should be considered whenconservative treatments fail. References: 1) Neuman, SAet al. Post Dural Puncture Headache Following Intrathe-cal Drug Delivery System Placement. Pain Physician.2019 16:101–107. 2) Riley, CA, et al. Complications fol-lowing large volume epidural blood patches for postduralpuncture headache. Lumbar subdural hematoma andarachnoiditis: initial effect or final cause? Journal of Clini-cal Anesthesia. 2009 21:355–359. 3) Hardy, PA. ExtraduralBlood Patch of a Cerebrospinal Fluid Cutaneous Fistula inthe Presence of an Intrathecal Drug Delivery System: ACase Report. Anesthesiology. 1994 81:1299–1300.Funding: None

138Cervical Interlaminar Epidural Catheter-GuidedSteroid Injection as an Alternative to BilateralCervical Transforaminal InjectionsWilliam Grief, [email protected],Justin Boge, DO1, John Vogel, MD1, (1) San AntonioMilitary Medical Center, San Antonio, TXTransforaminal cervical epidural steroid injections areeffective for treating radicular neck pain, however theyentail risks not encountered by interlaminar cervical injec-tions. Most notably transforaminal injections haveincreased risk of brain and spinal cord infarct from injec-tion of intravascular particulate steroid into the vertebral

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artery. Interlaminar cervical injections carry less risk butare not considered as effective at localizing medicationdelivery. We describe utilization of interlaminar-placedepidural catheter guided injection of steroid as an alterna-tive to bilateral cervical transforaminal injections. Thecase involves a 47-year-old male with chronic constantneck pain radiating to his arms in a C6 distribution exac-erbated by neck extension. MRI revealed uncovertebraljoint degenerative changes and disc protrusion impingingupon the C6 nerve roots bilaterally. EMG/NCS con-firmed bilateral C6 radiculopathy. In lieu of bilateral cer-vical transforaminal injections, we utilized a radio-opaquecatheter for medication delivery. At the level of C7-T1, an18-gauge 9 cm Coude needle was inserted under fluoro-scopic guidance into the epidural space using the loss ofresistance technique. A 21-gauge spring-guided radio-opaque epidural catheter was inserted through the Coudeneedle to the level of C5-C6 on the left side, placementwas confirmed with contrast and dexamethasone wasinjected. The same was repeated on the right side, tran-siently stimulating the patient’s right-sided radicular pain.Post-procedure, the patient noted a 25% relief of his pain.Conclusion: Catheter guided cervical interlaminar epi-dural steroid injection as an alternative to transforaminalinjection warrants further study of efficacy and safety.References: 1) Scanlon GC, Moeller-Bertram T,Romanowsky SM, Wallace MS. Cervical transforaminalepidural steroid injections: more dangerous than wethink? Spine. 2007;32(11):1249–1256. 2) Furman MB,Giovanniello MT, O’Brien EM. Incidence of intravascularpenetration in transforaminal cervical epidural steroidinjections. Spine. 2003;28(1):21–25. 3) Larkin TM, Car-ragee E, Cohen S.: A novel technique for delivery ofepidural steroids and diagnosing the level of nerve rootpathology. J Spinal Disorders Tech 2003;16:186–192.Funding: None

139Interspinous Process Spacer for Moderate LumbarSpinal Stenosis: 2-year Results of a RandomizedControlled TrialThomas Haley, DO, [email protected],Jon Block, PhD2, Larry Miller, PhD2, (1) PerformanceSpine & Sports Physicians, East Norriton, PA, (2) The JonBlock Group, San Francisco, CAIntroduction: Treatment options for lumbar spinal ste-nosis (LSS) range from conservative care for mildsymptoms to open spinal decompression surgery forsevere and chronic symptoms. This study reports 2-yearclinical outcomes in patients with moderate LSS treatedwith an investigational (Superion) or an FDA-approved(X-STOP) control interspinous process spacer.Methods: This prospective, randomized, controlled IDE

trial (NCT00692276) received Institutional ReviewBoard approval and enrolled 250 patients (mean age:67 yr, 60% male) with radiographically confirmed mod-erate LSS unresponsive to at least 6 months conservativecare. Patients were treated randomly with the investiga-tional (n = 123) or control (n = 127) interspinous processspacer and followed through a minimum of 2 years.Results: Zurich Claudication Questionnaire (ZCQ)Symptom Severity and Physical Function scoresimproved 34% to 36% in both groups through 2 years.Patient Satisfaction scores at 2 years were 1.8 ± 0.9 withthe investigational spacer and 1.6 ± 0.8 with control. Axialpain decreased 64% with the investigational spacer and62% with control (both p < 0.001). Extremity paindecreased 79% and 71% with investigational and controlspacers (both p < 0.001). Back function assessed with theOswestry Disability Index similarly improved from base-line with investigational and control spacers (51% vs.49%; both p < 0.001). Freedom from reoperation at theindex level was 84% for the investigational spacer and83% for the control spacer at 2 years. Conclusions: Mid-term results suggest that the investigational interspinousprocess spacer provides similar benefit as the FDA-approved spacer in alleviating pain and improving backfunction in patients with moderate LSS who are unre-sponsive to conservative care.Funding: Funded by Vertiflex Inc.

140Epidural Lysis of Adhesions for Failed BackSurgery and Spinal Stenosis: Factors Associatedwith Treatment OutcomeEugene Hsu, MD, [email protected], Levan Atanelov, MDMS1, Anthony Plunkett, MD2, Nu Cindy Chai, MD3,Yian Chen, MD3, Steven P Cohen, MD3, (1) JohnsHopkins, Baltimore, MD, (2) Womack Army MedicalCenter, Fort Bragg, Southern Pines, NC, (3) Johns HopkinsSchool of Medicine, Baltimore, MDIntroduction: Failed back surgery syndrome (FBSS) andspinal stenosis (SS) represent challenging problems forpain physicians. One treatment for FBSS and SS is epi-dural lysis of adhesions (LOA). None of the studies exam-ining LOA for FBSS and SS to date have sought toidentify factors associated with outcomes. Materials andMethods: This was a multicenter, retrospective studyperformed in 115 patients who underwent LOA for failedback surgery syndrome (n = 104) or spinal stenosis (n =11) between 2004 and 2007. Twenty-seven demographic,clinical, and procedural variables were correlated with thepositive outcome, defined as ≥50% pain relief lasting ≥1month. Demographic and clinical characteristics werereported using descriptive statistics. Univariable andmultivariable logistic regression analyses were per-

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formed. Results: Overall, 48.7% experienced a positiveoutcome. In univariable analysis, those who had a positiveoutcome were older (64.1 years vs. 57.2; p = 0.02), whileuse of a reinforced catheter was associated with a negativeoutcome (47.2% vs. 52.8% success rate; p = 0.04). Inmultivariable analysis, age ≥81 years (OR 14.4, 95% CI2.3–117.8), baseline NRS score ≤ 9 (OR 6.5, 95% CI1.8–29.9) and patients on or seeking disability or Work-er’s compensation (OR 5.6, 95% CI 1.4–27.5) were sig-nificantly more likely to experience a positive outcome.Conclusions: Selecting patients for epidural LOA basedon demographic and clinical factors, may improve treat-ment outcomes. Procedural factors such as the use ofhyaluronidase and a navigable catheter that increasecosts and risks did not improve outcomes, so furtherresearch is needed before these become standard practice.References: 1) Friedly J, Chan L, Deyo R. Increases inlumbosacral injections in the Medicare population:1994to 2001. Spine 2007;32:1754–1760. 2) CherkinDC, Deyo RA, Loeser JD, Bush T, Waddell G. An inter-national comparison of back surgery rates. Spine1994;19(11):1201–6. 3) Chan CW, Peng P. Failed backsurgery syndrome. Pain Med 2011;12:577–606.Funding: None

141Trainees’ Attitudes and Perceptions Towards Useof Antero-Posterior/Lateral Versus PredominantlyContra-Lateral Oblique Fluoroscopic Views forProper Needle Placement in the InterlaminarCervical Epidural InjectionGaurav Jain, MD, [email protected],Haibin Wang, MD PhD1, (1) University of PittsburghMedical Center, Wexford, PAIncidence of dural puncture with interlaminar cervicalepidural injection (CEI) ranges from 0.25% to 2%.Higher risk may be because of narrow distance betweenthe ligamentum flavum and the spinal cord and absenceof the interspinous ligament in the cervical spine alongwith deficient ligamentum favum in the midline in manycases. Therefore, fluoroscopy (mainly antero-posteriorand lateral views) is now widely used for accurate needleplacement. However, commonly used loss of resistance orhanging drop techniques may still carry high rate of falsepositivity. Due to these technical challenges and potentialserious complications following CEI, trainees’ learningcurves for CEI may be slow and many may not be con-fident to perform it independently. However, using con-tralateral oblique view (40–50 degrees) combined withintermittent contrast medium injection can help the per-former to precisely estimate the epidural space andperform CEI with ease. By means of a survey based studyauthors intended to explore differences in trainees’ atti-tudes and perceptions about the use of above two fluoro-

scopic methods. An IRB-approved survey with tenquestions and likert-type responses was sent to 18 currentand former pain fellows from our institution. All fellowshad an opportunity to perform CEI with the use of bothfluoroscopic techniques. The central tendencies ofresponses will be calculated. Chi square test will be uti-lized to calculate any differences between two techniques.Authors also reviewed the details of contra-lateraloblique fluoroscopic views for proper needle placementin the interlaminar cervical epidural injection.Funding: None

142Electroacupuncture as an Adjuvant Therapy WillAccelerate Pain Reduction in Patients withLumbosacral Radiculopathy: A RandomizedControlled TrialAli Jalali, [email protected], Farhad Adelmanesh,MD2, (1) Iran University of Medical Sciences, Tehran, IRN,(2) Kasra Hospital, Toronto, ON, CANIntroduction: The effectiveness of adding electroacu-puncture (Eac) on gluteal trigger point (GTrP) as anadjuvant to conservative treatment was compared withconservative treatment in patients with lumbosacralradiculopathy (LSR) and positive GTrP. Material andMethods: Patients with LSR and GTrP were included ina controlled clinical trial. Patients were randomly allo-cated in two treatment groups (A/B). Group A had con-servative treatment plus five sessions Eac on GTrP, everyother day; whereas, group B had only conservative treat-ment. Conservative treatment comprised; relative bedrest, naproxen and Lyrica. Each Eac session lasted 20minutes. Persian version of Short Form McGill PainQuestionnaire 2 (P-SFMPQ2) was used to assess patientsbefore treatment and at the end of follow up period.Moreover, Visual Analogue Scale (VAS) was used atinclusion time and every other day for 5 times and twotimes in follow up periods, every week. The study wasapproved by local research committee and informedconsent was taken. Results: From 100 included patients93 cases completed the treatment. Study included 46patients in group A and 47 patients in group B. VAS scoredecreased 24.7 in group A and 49.2 in group B (P < 0.01).P-SFMPQ2 score decreased 41.3 in group A and 79.5 ingroup B (P < 0.01). Repeated measurement analysisrevealed significant difference (P < 0.04) in VAS scoresbetween two groups during treatment and follow upperiod. Conclusion: Including five sessions Eac in glutealregion of patients with LSR and positive GTrP, comparedwith only conservative treatment, will accelerate painreduction. References: 1) Adelmanesh F, Jalali A, Attar-ian H, Farahani B, Ketabchi SM, Arvantaj A, Raissi GR.Reliability, validity, and sensitivity measures of expandedand revised version of the short-form McGill Pain Ques-

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tionnaire (SF-MPQ-2) in Iranian patients with neuro-pathic and non-neuropathic pain. Pain Med. 2012Dec;13(12):1631–6.Funding: None

144Percutaneous Rupture of a Facet JointSynovial Cyst Using a Two-Needle Technique:A Case ReportAli Malik, [email protected], Kevin D Cairns,MD MPH2, (1) Larkin Community Hospital, MiamiBeach, FL, (2) Nova Southeastern University, FortLauderdale, FLIntroduction: Facet joint synovial cysts may be associ-ated with axial pain, radiculopathy, neurogenic claudica-tion, or even cauda equina syndrome.1–6 Percutaneousrupture of facet joint synovial cyst has been correlatedwith avoiding surgery, and has long-term outcomessimilar to surgical excision.7 Percutaneous rupture using asingle-needle technique has been described; however,attempts were not successful in all cases.7–10 CaseDescription: 60-year-old female presented with low backpain, right lower extremity pain, and paresthesias. MRIrevealed a right L5-S1 facet joint cyst, which displacedthe right L5 nerve root. Prior to presentation, the patientfailed an attempted single-needle percutaneous rupture.The decision was made to proceed with percutaneousrupture using a two-needle technique. A 22-guage needlewas inserted into the right L5-S1 facet joint, and a Tuohyneedle was inserted directly into the cyst through aninterlaminar approach. A solution of 20 mg Depo-Medrol and 2 cc hyaluronidase was simultaneouslyinjected through both needles, and the cyst was overpres-surized until loss of resistance was noted. Rupture wasconfirmed by injecting contrast into the facet joint, andvisualizing a normal epidurogram. The patient reportedsignificant pain relief immediately post-procedure. At4-month follow-up, the patient reported continued painrelief and denied any radicular symptoms. Conclu-sions: Percutaneous rupture of facet joint synovial cysthas been validated as an efficacious form of management.7

This case illustrates that a two-needle technique may bemore effective than a single-needle technique for percu-taneous rupture of facet joint synovial cysts. Refer-ences: 1) Braza, D. W., & Peterson, B. (2005). Lumbarsynovial cyst. American journal of physical medicine &rehabilitation, 84(11), 911–912. 2) Barbero, M., & Bos-cherini, D. (2011). Lumbar synovial cyst. The Journal oforthopaedic and sports physical therapy, 41(7), 533–533.3) Muir, J. J., Pingree, M. J., & Moeschler, S. M. (2012).Acute Cauda Equina Syndrome Secondary to a LumbarSynovial Cyst. Pain Physician, 15, 435–440.Funding: None

145Thermal Risk Assessment of NeurostimulationLeads due to MRI RF HeatingSteve Manker, BSME, [email protected],Jim Olsen1, Bryan Stem, BSE1, Jamu K Alford, PhD1,Heather Orser, PHD1, John Welter, MSEE1, (1) Medtronic,Minneapolis, MNIntroduction: Magnetic resonance imaging (MRI) is thepreferred imaging modality for the central nervoussystem and other soft tissues. The most important MRI-related hazard for neurostimulation patients is radiofre-quency (RF)-induced heating that has the potential tocause thermal damage to the epidural space and spinalcord.1 Materials/Methods: Studies were performed tocharacterize the RF heating risk of conventional leads aswell as new shielded, MR-conditional leads. Method-ological approaches included 1) comparative infraredimaging of SCS systems in gel phantoms after exposureto 64 MHz RF energy; 2) ISO/TS 10974 compliant mod-eling calibrated with animal studies and combined withMonte Carlo analyses to predict temperatures andnumber of thermal injuries; and 3) analysis of clinicalthermal dose exposures based on clinical scan dataprovided by major MR scanner manufacturers.Results: Infrared imaging confirms the bulk of energydissipation for conventional, unshielded leads occurs atthe electrodes, whereas energy dissipation is distributedalong the length of the lead for shielded, MR-conditionalleads. In modeling studies, conventional leads heat totemperatures exceeding 50°C in 10% of simulated30-minute MRI scans, while shielded, MR-conditionalleads stay below 43°C. Conclusions: MRI-related RFheating of conventional leads can exceed irreversiblethermal damage thresholds under clinical MRI condi-tions. MRI-related RF heating of shielded, MR-conditional leads stays consistently low across the rangeof clinical MRI conditions. A probabilistic, Monte Carloanalysis is required to assess the risk of thermal injury tofully account for thermal dose experienced by patientsand the range of parameters that affect MR-device inter-actions. References: 1) Coffey et al, MRI ConditionallySafe Neurostimulation Leads: Investigation of theMaximum Safe Lead Tip Temperature. 2013 manuscriptin submission.Funding: None

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147Predicting MRI Radiofrequency (RF) Heating Risksin Spinal Cord Stimulation (SCS) PatientsHeather Orser, PhD, [email protected],John Welter, MSEE1, Steve Manker, BSME1,Jamu K Alford, PhD1, Jim Olsen1, Bryan Stem, BSE1,Wanzhan Liu, PhD1, Michael L Kalm, MSEE1,(1) Medtronic, Minneapolis, MNIntroduction: Determining MRI RF heating safety is acomplex process that requires complete understanding ofthe potential interactions between the MRI system, leadbehavior, and individual patient characteristics.1 A com-prehensive analysis was performed to evaluate a newMR-compatible SCS lead. Materials and Methods: Anes-thetized porcine (Sus scroffa; n = 5) were implanted withleads and temperature probes in the spinal canal (Figure 1)and scanned in a 1.5T MRI system at multiple landmarks.MRI RF heating predictions from animal model simula-tions were compared to in vivo electrode temperaturemeasurement to confirm model accuracy. Multiple humanmodels were combined with several MRI coils to simulatethe electromagnetic effects due to variations in humanmorphology. Simulations were performed for hundreds ofclinical lead paths in each human model and combinedwith lead characterization analyses to predict the tempera-ture rise at the electrodes in the spinal cord for each patientsituation. Results: A comparison of in vivo tissue tem-peratures during actual MRI with predicted temperaturesfrom animal models (Figure 2) depicts model accuracy andprovides confidence in predicting patient RF electrodeheating across the range of clinical scenarios.3 Calculationof electrode temperatures across 10,000 different patient/device/MRI scenarios shows highly variable temperaturerise. The resulting temperature predictions demonstratedthat a lead designed for reduced RF heating producedtemperatures below 43C for the full range of implantscenarios. Conclusion: Safety of an MRI compatible SCSlead was demonstrated with in vivo-validated models thataccount for the full complexity of MRI environment andvariables. References: 1) ISO. 2012. ISO TS 10974:Assessment of the safety of magnetic resonance imagingfor patients with an active implantable medical device.Geneva, Switzerland: International Organization forStandardization. 2) Park, Sung-Min; Kamondetdacha,Rungkiet; Nyenhuis, John A. “Calculation of MRI-induced heating of an implanted medical lead wire with anelectric field transfer function”, Journal of Magnetic Reso-nance Imaging, Volume.26, Issue.5, pp.1278, 2007. 3)Orser, et al “Analysis and In-Vivo Results of MRI Radiof-requency Heating Due to Neuromodulation Systems,”International Neuromodulation Society 11th WorldCongress. June, 2013.Funding: Medtronic, Inc.

148Effects of Type of Surgery on PostoperativePain TrajectoryPatrick J Tighe, MD, [email protected], Ameet Patel,MD1, Roger Fillingim, PhD1, (1) University of Florida,Gainesville, FLAcute postoperative pain (POP) afflicts up to 60% ofsurgical patients. Prior work by Chapman et al. suggeststhat more than one-third of patients experience non-negative POP trajectories. Although factors such asgender, age, and surgery type can affect pain, little isknown about how pain changes over time with respect tothese factors. We compared how various surgical proce-dures impacted POP resolution in a retrospective cohortstudy. With over 300,000 pain observations (NRS scores)obtained from electronic medical records, we plottedpain scores during a period of five postoperative days bysurgical category and specific procedures for comparison.Regression lines were fitted using a high-performancemixed-models approach given the size and complexity ofthe dataset. The rate of POP resolution was measured inNRS units per day and was compared using two methodsof organizing type of surgery. With the 141 proceduresexamined, pain trajectories varied across a spectrum, witha mean change of −0.389 NRS units/day (99%CI, −0.166,−0.619; p < 0.01). However, patients undergoing inguinaland femoral hernia repair and semilunar cartilage exci-sion had increasing pain (0.2 units, p < 0.01), whereasthose undergoing lumpectomies and esophageal dilata-tion procedures had the highest rate of pain resolution.(−5.34 units/day; p < 0.01). Overall, patient populationsin most procedures possessed very similar low rates ofpain resolution. Further work is necessary to bettermodel POP trajectories and to determine sources of vari-ance in explaining the observed differences in time-basedcorrelates of POP experiences.Funding: None

149Occipital Neuromodulation: A Mayo ClinicRetrospective Analysis and Procedural PerspectiveThomas Pittelkow, DO, MPH,[email protected], Bradford Landry, DO1,Matthew J Pingree, MD1, Jason S Eldrige, MD2, (1) MayoClinic, Rochester, MN (2) ISIS, ASIPP, Rochester, MNIntroduction/Statement of the Problem: Attempts totreat refractory primary headache with neuromodulationcontinue to show promising results.1,2 However, leadmigration continues to be a prominent concern. Theprimary objective of our study was to identify surgicaltechniques, specifically anchoring of stimulator leadsdesigned to provide a tension-relief loop and use of ultra-sound for lead placement, which may minimize the risk ofmigration requiring surgical revision. In addition, we

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report postoperative complications. Materials andMethods: A retrospective chart analysis was completedafter Mayo Clinic IRB approval. Inclusion criteria weremet by 18 patients between 2004–2011 who had a trialand subsequent permanent occipital nerve stimulator(ONS) placement. Results: The group was comprised of9 males and 9 females, with a mean age of 47 years,ranging from 21 to 71 years. Documented tension-reliefloops placed via a 2-point anchoring technique waspresent in 14 of 18 patients. The use of ultrasound forinitial occipital lead placement was documented in 9 of 18cases. There was 1 clinically insignificant lead migrationnot requiring surgical revision, 1 battery malfunction, 1lead malfunction, and 2 post-implantation infections.Conclusions: The practice of occipital neuromodulationfor medically intractable primary headache disorderscontinues to show promising results. Utilization of a2-point anchoring technique per lead with a tension-relief loop, along with the use of ultrasound for leadplacement, appears to facilitate excellent paresthesia cov-erage and minimize the risk of lead migration. Refer-ences: 1) Natoli JL, A Manack, B Dean, et al. Globalprevalence of chronic migraine: a systematic review.Cephalalgia. 2010;30(5):599–609. 2) Saper JR, DWDodick, SD Silberstein, et al. Occipital nerve stimulationfor the treatment of intractable chronic migraine head-ache: ONSTIM feasibility study. Cephalalgia. 2011;31(3):271–285.Funding: None

150Retrospective Analysis of ConservativeTreatment Modalities for Lumbar Spinal Stenosis:A 2-Year ReviewSchuyler A Rogg, MD, [email protected],Fred N Davis, MD1, Rebecca J Risko, BSN RN2,Josh Peterson2, Payal Attawal, MD3, (1) Michigan PainConsultants, Sarasota, FL, (2) Michigan Pain Consultants,Grand Haven, MI, (3) Michigan State University,East Lansing, MIIntroduction/Statement of the Problem: Lumbar spinalstenosis is a common disorder of the spine that primarilyaffects middle aged and elderly patients.1,2 The goal ofthis study is to determine which conservative treatmentoptions obtain the best therapeutic results with optimumresource utilization. Materials and Methods: A retro-spective study was conducted at MPC, an interdisciplin-ary community based pain medicine practice in WestMichigan. The data was collected using the Pain HealthAssessment (PHA) within the PRISM™ Care Manage-ment System. PHA data is routinely gathered fromchronic pain patients in the practice using IRB-approvedlanguage in the consent forms. The PHA includes ques-

tions assessing pain scores, physical function, and psycho-social health. A retrospective study of 2157 patientsdiagnosed with lumbar spinal stenosis was conductedfrom 1/1/2011 to 3/31/2013, comparing various conser-vative treatment modalities to determine their efficacy intreatment of this condition. Percent relief and improve-ments in Objective Lower Body Functional Impairment(LBI) over 2 years were determined comparing meanscores using analysis of covariance (ANCOVA).Results: Both the Lumbar Epidural Steroid Injection(LESI) and Selective Nerve Root Block (SNRB) groupsshowed highest pain relief; 62% and 62.9%. LBIimprovement was the highest with the combination ofLESI and PT, showing an average improvement of19.6%. LESI and PT provided the largest benefit forclimbing a flight of stairs, bending/kneeling, and walking.Conclusions: Conservative care for lumbar spinal steno-sis, particularly LESI with PT, showed both significantpain control and improvement in physical function over a2-year period. References: 1) Alvarez JA, Hardy RH.Lumbar Spinal Stenosis: A common cause of back and legpain. American Family Physician. 1998 Apr 15;57(8):1825–1834. 2) Spivak JM: Degenerative Lumbar SpinalStenosis. J Bone Joint Surg Am 1998; 80 (7); 1053–1066.Funding: None

151Thermal Injury During Cooled RadiofrequencyAblation for Thoracic Facet SyndromeChristiana Roussis, [email protected],David Walega, MD1, (1) Northwestern Memorial Hospital,Chicago, ILIntroduction: Radiofrequency ablation (RFA) of medialbranch nerves (MBN) is a safe and effective treatment forchronic facet joint pain. Cooled radiofrequency ablation(C-RFA) is gaining popularity in pain management withtheoretical advantages of superior lesion size over con-ventional RFA. We present the first report of full-thickness skin burn resulting from C-RFA for thetreatment of thoracic facet syndrome. Case Report: A61-year-old female (BMI of 21.8 kg/m2) with thoracicfacet syndrome underwent C-RFA of the T2-5 medialbranch nerves (17 g 75 mm electrode, Thoracool, Baylis).Lesioning (60 degrees C x 120 sec) at the superior-lateralaspect of the thoracic transverse processes at each levelwas done. During lesioning of the T3 MBN, skin blanch-ing 15 mm in diameter was noted around the introducerneedle with sloughing of the superficial dermis andpatient complaints of pain and was aborted. Post-procedurally the skin injury here worsened in appearanceand took nearly 5 months to heal, despite fastidiouswound care (Figure 1,2,3). Discussion: C-RFA is amodality gaining popularity in pain management. Inter-

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nally cooled electrodes are capable of creating largevolume spherical lesions, a size advantage over conven-tional RFA. Though C-RFA lesion size may overcomethe anatomic variability of MBN location and improvepain outcomes, thin patients with little subcutaneous fator muscle may be at increased risk of skin burns duringC-RFA MBN. Skin burns at the site of the electrode is apotential risk of thermal neurolytic procedures. Refer-ences: 1) Mekhail N et al. Temperature Mapping ofCooled Radiofrequency Lesion of Human Cadaver Tho-racic Facet Medial Branches. Clin J Pain, 2011. 2) Baereet al. Adverse Events During Radiofequency Treatmentof 582 Hepatic Tumors. American Journal of Roentgen-ology, 2003. Vol 181: 695–700. 3) Huffman et al. Radiof-requency Ablation Complicated by Skin Burn. Seminarsin Interventional Radiology 2011 June; Vol 28(2): 179–182.Funding: None

153The Role of Neuromodulation in the Treatment ofRefractory Occipital NeuralgiaDaniel C Roth, DO MBA MS, [email protected],Thomas A. Straub, PA-C2, (1) Centers for Pain Relief, FortWayne, IN, (2) Summit Pain Management, Fort Wayne,INIntroduction: Approximately 23% of all adults and5%–10% of children complain of chronic recurringheadaches. This study aims to determine whether occipi-tal nerve stimulation is efficacious in improving headachefrequency and severity while maintaining equal efficacyin males and females. Methods: A retrospective chartreview was conducted on 17 patients who had previouslyfailed multiple medication regimens and, consequently,underwent placement of an occipital nerve stimulator.Statistical analysis of headache frequency and severity bygender at baseline and post-implantation was performedusing median testing and Independent-Samples Mann-Whitney U testing. Statistical analysis of pre- and post-stimulator headache severity and frequencies were thenperformed using Related Samples Friedman’s Two-WayAnalysis of Variance by Ranks testing. Finally, post-hoctesting was completed using Related Samples Friedman’sTwo-Way Analysis of Variance by Ranks testing toanalyze the 1-, 3-, and 6-month follow-up data.Results: When baseline headache frequency was com-pared to post-implantation headache frequency, therewas a reduction from a mean of 18.71 days ± 2.47 to 6.06Â ± 3.07 days on a 30-day scale. There was also a decreasein headache severity from a baseline mean of 9.00 ± 2.46on a 10-point scale down to a mean of 3.29 ± 1.64 on a10-point scale at 6-months post-implantation. Discussionand Conclusion: This study suggests that occipital nerve

stimulation could reduce headache severity and fre-quency in both male and female patients who suffer fromchronic headaches.Funding: None

154A Retrospective Review of Role of PerineuralSteroids for Ilioinguinal and Iliohypogastric NerveBlocks in Management of Chronic LowerAbdominal and Pelvic PainRajinikanth Sundara Rajan, [email protected],Anuj Bhatia, MBBS MD DNB FRCA MNAMS FIPPFRCPC2, Philip WH Peng, MD2, Allan Gordon, MBBSMD FRCPC3, (1) University Health Network,University of Toronto, Toronto, ON, CAN, (2) UniversityHealth Network, Toronto, ON, CAN, (3) Mount SinaiHospital, University of Toronto, Toronto, ON, CANIntroduction: The incidence of neuropathic pain inpatients with chronic postsurgical pain (CPSP) is high(around 50%). Steroids are often administered aroundsomatic nerves innervating lower abdomen and pelvicwall to relieve pain. The rationale for using steroids is toreduce peri-neural inflammation and edema, but there isa lack of information about factors related to success ofthis intervention. We present here data from patientswho were administered steroids around ilioinguinal (II)or iliohypogastric (IH) nerves under ultrasound (US)guidance to treat chronic lower abdomen and pelvic wallpain. Materials and Methods: Research ethics boardapproval was obtained prior to commencing the study.Data from 75 patients who received US-guided injectionsof steroids around II and IH nerves at our hospital fromJanuary 1, 2009, to July 31, 2013, was included. Dataabout demographics, clinical presentation, features ofneuropathic pain, details of surgery including complica-tions, psychological co-morbidities, present or past treat-ment, and analgesic response to perineural steroids wereextracted. Results and Conclusion: Multivariate logisticregression is being used to analyze factors associated withanalgesic response to II and IH perineural steroids. Finalresults and conclusions will be presented at the confer-ence. The results of this study will help in appropriate useof perineural steroids by identifying factors related tosuccess or failure of this intervention. References: 1)Haroutiunian, et al. The neuropathic component in per-sistent postsurgical pain: A systematic literature review.Pain 2013;154:95–102. 2) Devor, et al. Corticosteriodssuppress ectopic neural discharge originating in experi-mental neuromas. Pain 1985;22:127–37. 3) Thomassen,et al. Ultrasound- guided ilioinguinal/iliohypogastricnerve blocks for chronic pain after inguinal hernia repair.Hernia 2013;17:329–32.Funding: None

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155Spinal Cord Stimulator—Trial Lead MigrationStudy, Part IIJordan Tate, [email protected], Michael Osborne,MD2, (1) Mayo Clinic, Jacksonville, FL, (2) Mayo ClinicFlorida, Jacksonville, FLIntroduction/Statement of the Problem: To investigatepercutaneous spinal cord stimulator (SCS) trial leadmigration in the immediate post-operative setting. Wehave previously published trial lead migration at the endof a 3-day trial period. Results demonstrated averagemigration of 8.72 mm (SD 5.77) inferiorly for leadsanchored with tape in a manner to minimize downwardlead tension during flexion of the spine. In this study, weaim to determine the amount of lead migration immedi-ately following discharge of patients from the recoveryroom. Materials and Methods: This is a prospectiveobservational study with patients undergoing a routinepercutaneous SCS trial. Informed consent was obtained,and our protocol received IRB approval. Lead anchoringtechnique was standardized according to our previouslypublished taping protocol. A single physician using thesame lead type for all patients performed the procedures.A standardized x-ray protocol of lead position wasobtained intra-operatively and again immediately afterdischarge from the recovery room. Using our establishedmethod, SCS lead position was measured and movementwas calculated. We aim to enroll sufficient patients toachieve measurements on 20 leads. Results: Preliminaryfindings from 6 patients (9 leads) indicate the average leadmigration in the immediate post-operative period is3.6 mm (SD 3.9) inferiorly. Conclusions: This prelimi-nary data indicates that the immediate post-operativerecovery period contributes approximately 40% to thetotal amount of lead migration during a 3-day trial.Overall, the amount of movement in the immediate post-operative period is relatively small when using our pre-viously published taping technique. References: 1)Osborne MD, Ghazi SM, Palmer SC, Boone KM,Sletten CD, Nottmeier EW. Spinal cord stimulator–triallead migration study. Pain Med. 2011.Funding: None

156Objective Measurement of Pain Levels inPatients with Radicular Pain Treated bySpinal Cord StimulationNir Ben Israel, [email protected], Yariv Amos, MSc1,Mark Kliger, PhD1, Galit Zuckerman1, Erica Suzan, MSc2,Roi Treister, PhD3, Elon Eisenberg3, (1) MedasenseBiometrics Ltd, Ramat Yishai, ISR, (2) Rambam HealthCare Campus, Haifa, Israel, Haifa, Israel, ISR,(3) Massachusetts General Hospital, Harvard MedicalSchool, Boston, MABackground: Although pain induces changes in auto-nomic parameters, the extent to which these changescorrelate with the experience of pain remains underdebate. In a recent study1, we have shown that a combi-nation of multiple autonomic parameters, rather thaneach parameter by itself, successfully differentiatedbetween four categories of experimental pain intensity inhealthy subjects. The present study tests the ability ofsimilar combinations of autonomic parameters to differ-entiate between intensities of clinical pain in patientswith chronic pain. Methods: Twelve patients withchronic radicular (neuropatic) pain in one lower extrem-ity and permanent spinal cord stimulator (SCS) weretested twice in a random order: 30 min after turning theSCS on and 2 hours after turning it off. Patients ratedtheir present pain intensity on a numerical pain scale(0–100) at the beginning of each test. Photoplethysmo-gram (PPG) and skin conductance (SC) waveforms wererecorded for 120 s, using the PMD-100TM (Medasense,Israel), and the following autonomic parameters wereextracted: PPG amplitude, PPG amplitude variation,pulse rate (PR) interval, PR variability and SC fluctua-tions. The parameters were combined using a linearregression. Paired t-test was used for statistical analyses. p< 0.008 was considered significant due to multiple com-parisons (Bonferroni correction). Results: SCS activa-tion reduced average present pain intensity from 67 ± 20to 38 ± 18. In concordance, the combination of theparameters, but not each parameter alone, showed sig-nificant difference (p < 0.001) between the SCS states(Table I). Conclusions: These preliminary findingssuggest that autonomic-based multiparameter objectiveassessment can reliably differentiate intensities of clinicalpain. References: 1) Treister R, Kliger M, Zuckerman G,Goor-Aryeh I, Eisenberg E. Differentiating between heatpain intensities: the combined effect of multiple auto-nomic parameters. Pain. 2012 Sep;153(9):1807–14.Funding: This study was partially funded by Medasense bio-metrics ltd.

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157Treatment of CRPS II by Blockade/Ablation of theCommon Peroneal NerveJohn Vogel, MD, [email protected],William J Goff, MD1, Robert H Overbaugh, MD1,Karl A Lautenschlager, MD1, (1) San AntonioMilitary Medical Center, San Antonio, TXIntroduction/Statement/Problem: CRPS is a poorlyunderstood and often treatment-refractory conditionwith no FDA-approved treatment. A 42 year-old retiredsailor with a left talar fracture in 2010 and subsequentdevelopment of CRPS II by Budapest Criteria (pain,edema, skin color changes, allodynia, hyperpathia) wasevaluated after failure of lidocaine, gabapentin, and pre-gabalin to relieve his pain symptoms. His treatmentoptions were severely limited by the presence of an undi-agnosed coagulopathy requiring life-long Coumadin use.Materials and Methods: As his pain was predominantlyin a left common peroneal nerve distribution, he initiallyreceived a diagnostic nerve block using 40 mg Depome-drol and 1 0 mg bupivicaine, then 7 weeks later receivedultrasound-guided cryoablation of the nerve with an 18ga. cryoprobe with three cycles of 2 minutes freezing.Results: The nerve block drastically reduced his pain(8/10 to 0–2/10) as well his other CRPS symptoms for 3weeks. While he had gradual recrudescence of his painand edema, his allodynia, hyperpathia, and skin colorchanges did not return. Following cryoablation, he had 6months relief of all CRPS symptoms, and only his painsymptoms returned at the end of this period. Conclu-sions: We describe the successful treatment of CRPS IIby inhibition of a primary sensory nerve to the area ofpain. This observation suggests that successful regionalanesthesia may globally affect sympathetic function andalter abnormal nociceptive pain. Nerve ablation may rep-resent a treatment option in select patients with CRPS.References: 1) Trescot, Andrea M. Cryoanalgesia inInterventional Pain Management. Pain Physician2003;6:345–360. 2) Fanelli, RD et al. Cryoanalgesia abla-tion for the treatment of chronic post-herniorraphyneuropathic pain. Surgical Endoscopy 2003 Feb;17(2):196–200. 3) Krzyzek, M et al. Saphenous NerveCryoablation. Abstract presented at the Annual Meetingof the American Society of Regional Anesthesia, 2012.Funding: None

158Successful Treatment of SpontaneousLow-Pressure Headache Due to Prominent CervicalCSF Leak with Cervical Epidural Blood PatchEugene Wang, MD, [email protected],Dajie Wang, MD2, (1) Pain Fellow, Jefferson Pain Center,Thomas Jefferson University Hospitals, Philadelphia, PA,(2) Jefferson Pain Center, Thomas Jefferson UniversityHospitals, Philadelphia, PAIntroduction: Spontaneous low pressure headache(SLPH) is a vexing neurological ailment that oftentimescannot be treated with conservative therapy. We presenta case of successful treatment of a 48-year-old gentlemanwith SLPH who has radiographic evidence of prominentCSF leak with fluid collection at the C1-2 level. He didnot have lasting relief with lumbar epidural blood patchesbut had significant relief of postural headache with cer-vical epidural blood patch. Methods: Fluoroscopic-guided placement of 18 gauge epidural needle intoC7-T1 interlaminar space was performed. An epiduralcatheter (Braun Perifix 20G) was advanced to C2 level(1st patch) and C3 level (2nd patch). Epidurogram withOminipaque injections confirmed contrast in the poste-rior and lateral epidural space. Autologous venous bloodwas then administered. Results: This patient receivedtwo lumbar epidural blood patches without lasting relief.Given the radiographic evidence of CSF leak at C1-2level, the patient was then treated with a cervical epiduralblood patch, of which headache pain relief lasted 6months. A repeated cervical blood patch was performed,and the patient has been headache-free for nearly 1 yearto date. Conclusion: Based on the successful treatment ofthis patient’s SLPH, we advocate patients undergo cer-vical epidural blood patches to target the site of dural leakidentified by imaging studies to improve the efficacy ofthis intervention. This case demonstrated that placementof cervical epidural blood patch, despite its inherent risks,may be more effective than lumbar epidural blood patchin treatment of cervical CSF leak. References: 1) BenzonHT, Nemickas R, Molloy RE, et al: Lumbar and thoracicepidural blood injections to treat spontaneous intracra-nial hypotension. Anesthesiology 1996; 85:920–922.2) Rando TA, Fishman RA: Spontaneous intracranialhypotension. Report of two cases and review of the lit-eratureNeurology 1992; 42:481–487. 3) Benzon et al.Essentials of Pain Medicine, 3rd Edition. “PostmeningealPuncture Headache and Spontaneous Intracranial Hypo-tension”. 2011, 40:275–276.Funding: None

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159Ultrasound Guided Pudendal Nerve Block:A Cadaveric StudyYuexiang Wang, [email protected],Naveen Murthy, MD1, Wenchun Qu, MD PhD1,Matthew J Pingree, MD1, (1) Mayo Clinic,Rochester, Rochester, MNIntroduction: Pudendal neuralgia is a common cause ofchronic pelvic pain. Ultrasound-guided pudendal nerveblock (PNB) has been shown to be an effective option oftreatment.1–2 However, the spread of injectate post-injection has not been well described. The purpose of thisstudy is to evaluate the spread of contrast followingultrasound-guided PNB using coned beam computedtomography. Materials and Methods: Ultrasound-guided PNB was performed bilaterally in 2 cadavers witha 5 MHz curvilinear transducer. The target site was thespace between the sacrotuberous ligament and sacrospi-nous ligament, just medial to the ischial spine. Four mil-liliters of iodine-based contrast was injected in the targetlocation. Coned beam CT was then performed to evalu-ate the contrast spread. The Institutional Review Boardruled that no formal review of this study was required.Results: Coned beam CT confirmed accurate needleplacement in the interligamentous space in all four injec-tions (100%). Contrast was found in the perirectal fat inthree injections, Alcock’s canal in two injections andgluteus maximus and piriformis in one injection. Onlyapproximately 20% of the injected contrast was found inthe interligamentous space while the remaining contrastwas seen above mentioned surrounding soft tissues.There was no vascular spread of contrast. Conclu-sion: Ultrasound-guided PNB in the inter-ligamentousspace is accurate. However, approximately 80% of the4 ml of injectate spread into the surrounding soft tissuesimplying that a reduced volume of injectate should beconsidered. References: 1) Bellingham GA, Bhatia A,Chan CW, Peng PW. Randomized controlled trialcomparing pudendal nerve block under ultrasound andfluoroscopic guidance. Reg Anesth Pain Med.2012;37(3):262–6. 2) Rofaeel A, Peng P, Louis I, ChanV.Feasibility of real-time ultrasound for pudendal nerveblock in patients with chronic perineal pain. Reg AnesthPain Med. 2008;33(2):139–45.Funding: None

160Comparison of Betamethasone Dosing forTransforaminal Epidural Steroid Injection inLumbar Radicular Pain ManagementWaylan Wong, MD MS, [email protected],Dermot Maher, MD1, Daniel Iyayi2, Howard L Rosner,MD2, Ronald Wender, MD2, Roya Yumul, MD PhD2,(1) Cedars Sinai Medical Center, Los Angeles, CA,(2) Cornell University, Ithaca, NYIntroduction: Although transforaminal epidural steroidinjections are commonly used to treat lumbar radicularpain, corticosteroid dose varies widely amongst practitio-ners.1 We determined if there was any difference in painoutcomes and narcotic requirements between two differ-ent dosing regimens of betamethasone. Materials andMethods: After obtaining IRB approval, we retrospec-tively reviewed de-identified patient charts from 2012 to2013 of those who received their first transforaminal epi-dural steroid injection at our pain clinic. Patients weredivided into two groups: 3–4.5 mg and 6 mg betametha-sone. Multiple injections were excluded. Narcotic use andverbal rating pain scores (VRS) up to 4 weeks after theprocedure were collected. Results: 171 patients wereanalyzed. The change in VRS pain score after the proce-dure was not significantly different between the 3–4.5 mgand 6 mg groups (−1.21 ± 2.49 vs. −0.592 ± 2.68 respec-tively, p = 0.79). Similarly, the difference in pre- to post-procedure narcotic use did not reach statisticalsignificance (3–4.5 mg group: −2.52 ± 15.2 mg vs. 6 mggroup: −2.69 ± 13.9 mg in oral morphine equivalents, p =0.93). Conclusions: Reduction in VRS pain scores andnarcotic usage were not significantly different betweenthe 3–4.5 mg vs. 6 mg betamethasone groups, suggestingthat a lower steroid dose can yield similar pain efficacyand opiate-sparing effects. Our results concur with otherprospective epidural steroid injection studies utilizingdifferent yet equipotent corticosteroids.2,3 References: 1)Cluff R et al. The technical aspects of epidural steroidinjections: a national survey. Anesth Analg 2002;95:403–8, table of contents. Comment in: Anesth Analg2003; 96:907–8; author reply 908. 2) Ahadian FM,McGreevy K, Schulteis G. Lumbar transforaminal epi-dural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Reg Anesth Pain Med. 2011Nov-Dec;36(6):572–8. 3) Kang SS et al. The Dosages ofCorticosteroid in Transforaminal Epidural Steroid Injec-tions for Lumbar Radicular Pain Due to A HerniatedDisc. Pain Physician 2011;14:361–370.Funding: None

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161Radiofrequency Intradiscal Biacuplasty forTreatment of Discogenic Lower Back Pain:A 12-Month Follow-UpLeonardo Kapural, MD PhD, [email protected],Bruce Vrooman, MD2, Sheryar Sarwar, MD2,Ljiljana Krizanac-Bengez, MD PhD2, Richard Rauck,MD1, Christopher Gilmore, MD1, James North, MD1,Nagy Mekhail, MD PhD2, (1) Carolinas Pain Institute andCenter for Clinical Research, Winston-Salem, NC,(2) Pain Management Department, Cleveland Clinic,Cleveland, OHIntroduction: Discogenic low back pain (LBP) accountsfor a great proportion of patients suffering from chronicLBP. More recently, growing interest has emerged inminimally invasive treatment options for discogenic LBP.Intradiscal biacuplasty (IDB), which uses cooled radiof-requency (RF) transdiscal electrodes to ablate sensoryfibers in the posterior aspect of the intervertebral disc, isone such percutaneous option. We previously presented6-month results of a double-blinded sham randomizedstudy, now we present data collected after unblinding,with up to 12 months follow up. Methods: Physical func-tion, pain, and disability were assessed using the SF-36,numerical rating scale (NRS), and Oswestry. Subjectswere unblended at 6 months and those randomized tosham procedure were offered IDB. Results: 22 out of 27subjects in the original active treatment group were fol-lowed until 12 months. Out of 30 in sham group, 24chose to cross-over after unblinding at 6-months follow-up. 20 cross-over patients completed follow up at 6months. No complications or adverse events related tothe study procedure were reported. Treatment patientshad a clinically significant improvements in physicalfunction measured by SF-36 (Δ = 22) and pain (Δ = −2.9).In cross-over subjects across all time-points post activeIDB treatment similar data were obtained. Conclu-sions: Clinically significant improvements after IDB ini-tially reported at 6 months, were maintained at 9 and 12months. In crossover patients improvements in physicalfunction and pain did not differ statistically from thoseof patients originally randomized to IDB treatment.References: 1) Carragee EJ. N Engl J Med 2005;352(18):1891–98; 2) Kapural L et al. Pain med2013;14(3):362–73.Funding: Baylis Medical Inc., Montreal, Canada

Pharmacological

162Relationship Between Pain Relief, SleepImprovement, and Overall Impression ofImprovement in Treatment of Patients withPostherpetic Neuralgia (PHN)Shay Bujanover, [email protected], Neel Mehta,MD2, Rajiv K Shah, MD2, Amitabh Gulati, MD FIPP3,(1) Depomed Inc, Newark, CA, (2) New York-PresbyterianHospital-Weill Cornell Medical College, New York, NY,(3) MSKCC, New York, NYIntroduction: For patients with PHN treated with gas-troretentive gabapentin (G-GR), characterization of rela-tionships between changes in pain, sleep, and Patients’Global Impression of Change (PGIC) may facilitateunderstanding about how these relationships affectpatients’ overall well-being. Methods: Data from twoPhase 3 [1–3] and one Phase 4 clinical trial of patientswith PHN who received G-GR 1800 mg once-daily (n =556) were integrated. Visual analog scale (VAS) and BriefPain Inventory (BPI) were completed at baseline and endof study (Week 10 for Phase 3 and Week 8 for Phase 4),and PGIC at end of study. Results: At end of study, therewere statistically significant, positive correlationsbetween the percent reductions from baseline in the VASand BPI Sleep Interference scores. Likewise, improve-ments on the PGIC were positively associated withpercent reductions from baseline in both VAS and BPISleep Interference scores. Percent change in the VASscore had greater influence on the probability of being“Much” or “Very Much” improved on the PGIC than didpercent change in the BPI Sleep Interference score (p <0.0001 vs. p = 0.0063), and was also a stronger, indepen-dent predictive factor (p < 0.0001 vs. p = 0.0026). Con-clusions: For PHN patients treated with G-GR(1800 mg once-daily), there was a significant correlationbetween reductions in pain on the VAS, reductions insleep interference on the BPI, and overall improvementson the PGIC. Compared with BPI Sleep Interference,percent changes in the VAS score had greater influenceon improvements on the PGIC. References: 1) WallaceMS, Irving G, Cowles VE. Gabapentin extended-releasetablets for the treatment of patients with postherpeticneuralgia: a randomized, double-blind, placebo-controlled, multicentre study. Clin Drug Investig2010;30(11):765–76. 2) Sang CN, Sathyanarayana R,Sweeney M; DM-1796 Study Investigators. Gastroreten-tive gabapentin (G-GR) formulation reduces intensity ofpain associated with postherpetic neuralgia (PHN). ClinJ Pain 2013;29(4):281–8. 3) Rauck RL, Irving GA,Wallace MS, Vanhove GF, Sweeney M. Once-daily gas-troretentive gabapentin for postherpetic neuralgia: inte-grated efficacy, time to onset of pain relief and safety

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analyses of data from two phase 3, multicenter, random-ized, double-blind, placebo-controlled studies. J PainSymptom Manage 2013;46(2):219–28.Funding: None

164Are Repeat Outpatient Ketamine InfusionsAssociated with Cognitive Dysfunction?Ramon Go, [email protected], May L Chin, MD1,Richard Amdur, PhD, (1) George Washington UniversityMedical Center, Washington, DCKetamine, an NMDA antagonist can be effective inrelieving severe neuropathic pain. The NMDA receptoris involved in learning and memory. The objective of thisstudy is to investigate whether repeat outpatient ket-amine infusions are associated with cognitive dysfunctionas measured by the Manos 10-point clock test, a validatedscreening tool for cognitive dysfunction. With IRBapproval, patients undergoing repeat outpatient ketamineinfusions were asked to complete a Manos 10 point clocktest before and after each ketamine infusion and on thefollow-up clinic visit 2 to 4 weeks after the last infusion.Numerical rating scores for pain were also obtained pre-and post-infusion and on follow-up visit. Each patientwas given ketamine infusions on 3 consecutive days.These infusions were repeated 4 to 16 weeks apart. Ninepatients underwent 81 ketamine infusions. We examinedthe association of pre- and post-infusion clock scoreswith a set of predictors including the number of repeatketamine infusions and the dose of ketamine adminis-tered. A multivariate model was tested using a repeated-measures generalized estimating equation with the SASGenmod procedure and p-values for the z-test are pre-sented. In our study, patients with neuropathic painreceiving multiple repeat outpatient ketamine infusionsdid not demonstrate cognitive dysfunction as tested withthe Manos10-point clock scale. References: 1) Tang,W.K., Liang, H.J., Lau, C.G., Tang, A., Gabor, S. Rela-tionship Between Cognitive Impairment and DepressiveSymptoms in Current Ketamine Users. J. Stud. AlcoholDrugs.2013 (74):460–8. 2) Morgan, C.J., Muetzelfeldt,L., Curran, H.V., Ketamine use, cognition and psycho-logical wellbeing: a comparison of frequent, infrequentand ex-users with polydrug and non-using controls.Addition. 2009. Jan;104(1):77–87. 3) Manos, P.J., Wu, R.The ten point clock test: a quick screen and gradingmethod for cognitive impairment in medical and surgicalpatients. Int J Psychiatry Med. 1994;24(3):229–44.Funding: None

165Opioid Dose Reduction Does Not Worsen PainScores, Perceived Functional Abilities or AberrantDrug Behaviors in Patients on High-Dose OpioidsDavid J DiBenedetto, MD, [email protected], Rachel Porter, RN-BC1, Mary Jane Estrada-Lyder,APN-BC1, Kathleen Conroy, RN1, Alka Mehta,PharmD Candidate2, Alyssa Goldberg, Medical Assistant2,Zahid H Bajwa, MD3, (1) Boston PainCare, Waltham,MA, (2) MCPHS University, Gilbert, AZ, (3) BostonHeadache Institute at Boston PainCare, Waltham, MAPurpose: High-dose opioid use is associated with hyper-algesia, mood disorders, and endocrine dysfunction.1

Efficacy of high-dose opioids has been questioned.2 Weexamined the impact of dose reduction in patients onhigh-dose treatment on selfreported pain scores and inci-dence of aberrant drug behaviors (ADB). Methods: AHigh-Dose Reduction Group (HDRG) with a startingopioid dose ≥200 mg in morphine equivalents (MEQ)undergoing dose reduction and a randomly selectedcontrol group not undergoing reduction were identifiedbetween September 2012 and August 2013. Functionalpain scores (Matheson Functional Pain Scale) andperceived functional ability (Roland Morris DisabilityIndex-RMDI) were examined at study inceptionand completion. Urine drug test results (confirmed viaGC/MS testing) were examined to determine the inci-dence of ADBs. Results: HDRG (60 subjects) averagestarting and ending opioid dose were 508 MEQ and 305MEQ (40% reduction) vs. 105 MEQ and 203 MEQ inthe control (49 subjects). HDRG starting and endingFunctional Pain Scores were 6/10 and 5.4/10 vs. 6/10 and5.3/10 in Control. HDRG RMDI scores starting andending were 9.7 and 9.8 vs. 12 and 12.6 in Control.Comparing the 10 highest starting dose (HDRG 1258MEQ vs. Control 239 MEQ) and highest pain subjects(pain scores ≥7/10) showed no differences in ending painscores or RMDI values. HDGR ADB was 5/60 (8%) vs.7/49 (14%) for control. Conclusion: Opioid dose reduc-tion does not affect functional pain scores or functionalabilities compared to patients on higher opioid doses.Both groups exhibited similar rates of ADBs. Refer-ences: 1) Beth Darnall, PhD, Brett Stacey, MD, andRoger Chou, MD. Medical and Psychological Risks andConsequences of Long-Term Opioid Therapy inWomen. Pain Medicine 2012; 13: 1181–1211. 2) JørgenEriksen, Per Sjøgren, Eduardo Bruera, Ola Ekholm,Niels Rasmussen. Critical issues on opioids in chronicnon-cancer pain: An epidemiological study. Pain 2006,125, 172–179.Funding: None

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166Effect of Diclofenac Sodium Topical Solution onCoagulation Parameters in Patients with KneeOsteoarthritis Taking Anticoagulants andAntithromboticsTheresa Gillis, PA-C, [email protected],Nathan Wei, MD1, (1) Arthritis Treatment Center,Frederick, MDIntroduction: Nonsteroidal anti-inflammatory drugs(NSAIDs) decrease platelet adhesiveness and aggrega-tion and may interact with coadministered anticoagulantand antithrombotic medications.1 Studies evaluating theeffect of topical NSAIDs on this process are lacking.This study evaluated whether diclofenac sodium topicalsolution 1.5% in dimethyl sulfoxide interferes withcoagulation parameters in older patients receiving anti-coagulant therapy. Materials and Methods: This open-label, single-center study enrolled male or femalepatients ≥55 years with moderate-severe knee osteoar-thritis on stable doses of anticoagulation and antithrom-botic medications, including aspirin, clopidogrel,dabigatran, or warfarin. Coagulation parameters weremonitored at baseline through 4 weeks of treatment forpatients beginning study treatment with diclofenacsodium topical solution 1.5% administered as 40 dropsto both knees 4 times daily. Institutional review boardapproval and informed consent were obtained beforepatient enrollment. Results: Data available from 21patients aged 56 to 82 years (mean, 70 years). Increaseswere observed in median international normalized ratio(baseline, 1.5; final evaluation,1.9) and median pro-thrombin time (baseline, 16.7 seconds; final evaluation,21.1 seconds) among warfarin users (n = 9). Median acti-vated partial thromboplastin time was similar at baseline(53.4 seconds) and final evaluation (53.8 seconds) amongdabigatran users (n = 4). Median platelet aggregationtime decreased in aspirin and clopidogrel users (n = 10;baseline, 300 seconds; final evaluation, 232 seconds).Adverse events (all classified mild or moderate) wereobserved in 4 patients, and did not include bleeding.Conclusions: Diclofenac sodium topical solution 1.5%did not interfere with coagulation parameters to a clini-cally significant degree in patients with moderate-severeknee osteoarthritis receiving anticoagulant therapy. Ref-erences: 1) Lattuca B, Khoueiry Z, Malcles G, DavyJ-M, Leclercq F. Drug interactions between non-steroidal anti-inflammatory drugs and cardiovasculartreatments (except anti-agregant therapy). AntiinflammAntiallergy Agents Med Chem. 2013;12:36–46.Funding: Technical editorial and medical writing support forthe development of this abstract was provided by David Schro-eder, Synchrony Medical Communications, LLC, West Chester,PA. Funding for this support was provided by the Arthritis

Treatment Center, Frederick, MD and Mallinckrodt Pharma-ceuticals, Hazelwood, MO.

167Inadequate Pain Control with Oxycodone in aPatient Taking DilantinZhaodi Gong, MD PhD, [email protected],Donna-Ann Thomas, MD1, (1) Yale-New Haven Hospital,New Haven, CTIntroduction: Pharmacological management of cerebralpalsy (CP) patients with opioids requires careful titrationof the dose not only because respiratory depression ishard to detect in mentally retarded CP patients but alsobecause of the complex drug-drug interactions betweenopioids and anti-seizure medication that CP patientsoften take for seizure prophylaxis or treatment. Materialand Methods: We report on a 25–year-old male with CPadmitted to Yale-New Haven hospital for club foot cor-rection. Pre-op patient received right femoral and popli-teal peripheral nerve blocks with good pain relief with0.2% Ropivacaine post-operatively. However, on thenight of the surgery, patient accidentally pulled out hisright femoral catheter. Oral Oxycodone 5/10/15 mgQ4hr prn sliding scale was initiated. However, patientappeared very uncomfortable after getting 10 mg oxyco-done every 4 hours for three doses without any relief ofpain. Parents were contacted to confirm that this patientis opioid-naïve, and his only home medication is Dilantinfor seizure that he has been taking for over 10 years.Results: Because of the concern of interaction betweenoxycodone and Dilantin (induces liver P-450 metabo-lism), we changed oxycodone to morphine. Patient hadadequate pain control after first dose of morphine andwas discharged home on the next day with satisfactorypain control. Conclusion: Dilantin might affect oxyco-done metabolism via induction of P-450 enzymes. Switchto alternative opioids (morphine or hydromorphone)should be considered if oxycodone is ineffective for paincontrol in patients on Dilantin. References: 1) ThornCF, Whirl-Carrillo M, Leeder JS, Klein TE, Altman RB.PharmGKB summary: phenytoin pathway” Pharmacoge-netics and genomics. 2) Lynch T, Price A. The Effect ofCytochrome P450 Metabolism on Drug Response, Inter-actions, and Adverse Effects. Am Fam Physician. 2007;76(3):391–396. 3) Inducers-cytochrome P450 enzymedrug table. Pharmacology Weekly Inc.Funding: None

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168Gender Differences in the Placebo AnalgesicResponse: Results in the Chronic Low BackPain ModelSara Connolly, [email protected], Elias Abousaad, MD1,Maxine M Kuroda, PhD MPH1, Amy Kirsling, MPA1,R Norman Harden, MD1, (1) Rehabilitation Instituteof Chicago, Chicago, ILIntroduction: Many trials use a single blind placebolead-in (SBPL) period to control for the placeboresponse. However, reports show differences in theplacebo analgesic response by gender.1 We aim tocompare the pain and psychometric responses of femalesand males with chronic low back pain (LBP) during aSBPL period. Materials and Methods: We analyzed datafrom 18 subjects (8 Females & 10 Males) with CLBPenrolled in an IRB approved, double-blind, placebo-controlled pharmaceutical trial for the efficacy of hydro-morphone ER. Prior to randomization, subjectscompleted a 2-week SBPL phase. Pain metrics (McGillPain Questionnaire Short Form (MPQ-SF) and VisualAnalogue Scale (VAS)), and psychometric measures (PainDisability Index (PDI), Pain Anxiety Symptom Scale(PASS), Center for Epidemiologic Studies Depressionscale (CESD-10)) were collected at baseline and afterSBPL. Gender differences were evaluated by indepen-dent test. Results: MPQ-Total scores decreased more infemales than males after SBPL (p = 0.046). Similarly,change in VAS and MPQ-Sensory subscores were lowerfor females than for males, with differences approachingsignificance (p = 0.104, p = 0.074, respectively). However,males showed insignificantly lower PDI scores afterSBPL than females. Other psychometric measures(PASS, CESD-10) showed no significant difference basedon gender. Males and females did not differ significantlyin age, pain duration, or education. Conclusion: Femalesreported a larger placebo analgesic effect than males aftera SBPL period. References: 1) Franconi F, Campesi I,Occhioni S, Antonini P, Murphy MF. Sex and gender inadverse drug events, addiction, and placebo. Handb ExpPharmacol. 2012;(214):107–26.Funding: Supported by a grant from Covidien, Inc./Mallinckrodt Pharmaceuticals.

169Management of Post Bariatric Surgery NeuropathicPain (PBSNP): Review of Available EvidenceVasanth Kattalai-Kailasam, [email protected],Claricio Decastro, MD1, (1) Harlem Hospital/ColumbiaUniversity, New York, NYIntroduction: Following any type of bariatric surgery,neurologic complications are reported to occur in 5 to16% of all patients.1 Among neurologic complications,54% are peripheral neuropathy. Pain precedes other

manifestations of neuropathy in most occasions. Objec-tive: Review the literature and summarize the currentevidence for the management of PBSNP. Materials &Method: We searched Pubmed, MEDLINE, Googlescholar, EMBASE, and Cochrane Database of Reviewsfor available studies published since 1990. Results: Threehigh quality retrospective cohort studies with focus onPBSNP were identified. Search with the keywordsreturned with the following number of citations: Neuro-pathic pain management post obesity surgery: 0; Neu-ropathy Post Bariatric Surgery: 30; Bariatric beriberi: 9;Post Bariatric Surgery complication: 33; Acute postgastricreduction surgery (APGARS) neuropathy: 1 Pharmacoki-netics PBS: 21. Discussion: Micronutrient absorptiondeficiency has been proposed as a possible mechanism,but despite structured nutritional counselling and followup, neuropathic pain appears to be an unavoidable com-plication.2 To our knowledge, evidence-based workingprotocol for management of PBSNP has not yet beencreated. Higher prevalence of psychiatric illness3 and Dia-betes Mellitus, which, per se, could play a role in pathol-ogy and/or perception of pain. Bariatric surgery groupwas exposed to only 57.7% of duloxetine in a trial.44Reduced bioavailability of SSRI PBS reported in a study.5

Conclusion: Identification of pathology of PBSNP andoptimal dosage for adequate pain control with knowledgeregarding analgesic absorption following bariatricprocedures are the need of the hour. Alternate routeof drug administration/interventions/Psychotherapeuticmethods are venues for future research. References: 1)Koffman BM, Greenfield LJ, Ali II, Pirzada NA. Neuro-logic complications after surgery for obesity. MuscleNerve. 2006 Feb; 33.(2):166–76. 2) Juhasz-Pocsine K,Rudnicki SA, Archer RL, Harik SI. Neurologic compli-cations of gastric bypass surgery for morbid obesity. Neu-rology. 2007 May 22;68(21):1843–50. 3) David B. Sarwer,PhD; Naomi I. Cohn, BA et al., Psychiatric Diagnosesand Psychiatric Treatment Among Bariatric Surgery Can-didates. Obesity Surgery, 14, 1148–1156.Funding: None

171Prostaglandin E1 FacilitatesHyperpolarization-Activated CyclicNucleotide-Gated (HCN) Channel via Activation ofProstaglandin E Receptors of the EP2 Subtype inSomatosensory NeuronsJeeyoun Moon, [email protected], Yong-Chul Kim1,Jang Hyun Kim, Jee Youn Shin, (1) Seoul NationalUniversity Hospital, Seoul, KORHyperpolarization-activated cyclic nucleotide-gated(HCN) ion channels and their current, Ih, have beenreported to play an important role in neuropathic pain.The present study investigated the cellular action of

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PGE1 on HCN ion channel in primary dissociatedneurons of trigeminal ganglia (TG) in rats. Medium-sized TG neurons were prepared and whole-cell record-ings were made using patch electrodes. The Ih currentwas identified and the effects of PGE1 on Ih current weredetermined. To investigate the intracellular effect ofPGE1 on Ih current, an adenylyl cyclase inhibitor (MDL-12,330A hydrochloride) and an analogue of cAMP (8-Br-cAMP) was applied. Then, the subtype(s) of EP receptorwas examined. Finally, the frequency of action potentialelicited by a current injection after exposure to PGE1 wasdetermined in Ih-expressing TG neurons. Ih was identi-fied in the medium-sized TG neurons isolated from ratsand increased about 130% by PGE1 (Figure1). PGE1facilitated Ih current in a dose-dependent manner (ED50= 29 nM) (Figure 2). Adenylyl cyclase inhibitor and 8-Br-cAMP inhibited Ih current by PGE1. EP2 receptorantagonist inhibited Ih current by PGE1. Exposure toPGE1 enhanced their excitability by increasing actionpotential frequency in Ih-expressing TG neurons(Figure 3). PGE1 facilitated Ih current in medium-sized TG neurons in rats, which was mediated by EP2receptor by transmitting a signal to adenylyl cyclase andincreasing the intracellular concentration of cAMP.Exposure to PGE1 would control the firing of actionpotential by enhancing their excitability in Ih-expressingTG neurons.Funding: Seoul National University Hospital Grant

172An Inflammatory PlexopathyMimicking RadiculopathyNarayan R Kissoon, MD, [email protected],James C Watson, MD1, (1) Mayo Clinic, Rochester, MNIntroduction/Statement of the Problem: Inflammatoryplexopathy often mimics spondylotic radiculopathy buthas a distinct treatment algorithm. We present a case ofdiabetic lumbosacral radiculoplexus neuropathy(DLRPN) to stress key features that may have allowedearlier distinction from lumbar radiculopathy.Methods: Case report. Results/Case Report: A 65-year-old type two diabetic presented with an eight monthhistory of presumptive lumbar radiculopathy aftermoving a table. Initial complaints included mild low backpain, dysesthetic left thigh pain, and left foot numbness.Six weeks later she noticed a left foot drop and weaknesstraversing stairs. Lumbar MRI and CT myelogramshowed mild left L5 lateral recess stenosis. Multi-leveltransforaminal epidural steroid injections provided norelief. Surgical review felt the lateral recess stenosis insuf-ficient to explain symptoms. Four months prior to pre-sentation, she developed severe right groin/thigh painrequiring hospitalizations for pain control. Further

imaging, epidurals, and surgical consultations failed toalleviate or explain the symptoms. On presentation,physical examination showed multifocal bilateral lowerlimb weakness and sensory deficits with absent lowerextremity reflexes. On review of systems, she had an asso-ciated 50 pound weight loss. Conclusions: Key featurespointing to a diagnosis of DLRPN included multifocalityof signs and symptoms, step-wise progression, severelimb greater than back pain with subsequent weaknesstemporally and anatomically distinct from pain presenta-tion, significant weight loss, and uncertain imaging cor-relate. Identifying DLRPN as a cause of radicular painwith weakness can prevent unnecessary treatment ofasymptomatic degenerative spine disease and DLRPNresponds to high dose intravenous methylprednisolone.References: 1) Dyck, P.J. and J.E. Norell, Microvasculitisand ischemia in diabetic lumbosacral radiculoplexus neu-ropathy. Neurology, 1999. 53(9): p. 2113–21,Funding: None

173Direct Cytotoxic Effects of MethylprednisoloneAcetate with Preservatives on Rat’s Dorsal RootGanglion Sensory NeuronsN Nick Knezevic, MD PhD, [email protected],Kenneth D Candido, MD1, Aleksandar Krbanjevic, MDPhD2, (1) Advocate Illinois Masonic Medical Center,Chicago, IL, (2) University of Illinois, Chicago, ILIntroduction: Neuraxial injection of methylprednisoloneacetate (MPA) has been dogged by controversy, and thepresence of different additives in commercial glucocorti-coid preparations is one area of controversy. We previ-ously showed that MPA could be rendered 85% free ofpolyethylene glycol (PEG) by simple physical separationof elements in the suspension1. The objective of thepresent study was to explore possible cytotoxic effects ofMPA on rat sensory neurons. Methods: Dorsal rootganglia (DRG) neurons isolated from Sprague-Dawleyrats were exposed to PBS (vehicle); MPA from the origi-nal commercially prepared vial or to MPA with reducedconcentration of preservatives by using our previouslydescribed technique1 for 24 hours. Cells were stainedwith the TUNEL assay kit to detect a poptotic cells.Results: Our results showed that MPA with reduced pre-servatives caused 12.5% more apoptosis in DRG neuronsthan control cells (Figures 1 and 2); however, the differ-ence was not statistically significant (p = 0.060)(Figure 1A,B). Exposure of these neurons to MPA withintact preservatives caused almost 50% more TUNELstained apoptosis than in control cells (p < 0.0001). Fur-thermore, the difference between MPA with intact pre-servatives and MPA without preservatives also showedhigh statistical significance (p < 0.0001) (Figure 1C).

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Conclusions: Results of the present study identified adirect cytotoxic effect of MPA with preservatives on ratDRG sensory neurons. Nevertheless, the reduction ofconcentrations of preservatives from MPA may prove tobe an alternative to using compounding of MPA, at leastfor cases where the use of compounding is being under-taken to provide MPA without preservatives. Refer-ences: 1) Candido KD, Knezevic I, Mukalel J, KnezevicNN. Enhancing the relative safety of intentional or unin-tentional intrathecal methylprednisolone administrationby removing polyethylene glycol. Anesth Analg2011;113:1487–9.Funding: None

174A Pooled Analysis of Renal Safety in Placebo- andActive Comparator-Controlled Phase III Trials ofMultiple-Dose Injectable HPβCD-Diclofenac inSubjects with Acute Post-Operative PainStephen Daniels, [email protected],Tong Gan, MD2, Douglas Hamilton, MBA3,Peter G Lacouture, PhD4, Olufunmibi Taiwo, PharmD4,Lauren H Min4, Christian Russel Reyes, MS4,Daniel B Carr, MD5, (1) Premier Research Group,Austin, TX, (2) Duke University Medical Center,Durham, NC, (3) New Biology Ventures LLC,San Jose, CA, (4) Hospira, Inc., Lake Forest, IL,(5) Tufts Medical Center, Chestnut Hill, MAIntroduction: While injectable non-steroidal anti-inflammatory drugs are a key component of multi-modalanalgesia regimens, safety concerns related to renal func-tion may limit use in some patients. The objective of thispooled analysis was to examine the renal safety ofHPβCD-diclofenac, administered for ≤ 5 days followingorthopedic or abdominal/pelvic surgery. Methods: Datafrom two multicenter, double-blind clinical trials inves-tigating the efficacy and safety of HPβCD-diclofenacversus placebo and ketorolac were examined for inci-dences of renal adverse events (AEs) and shifts in serumcreatinine and blood urea nitrogen (BUN). The pooledpopulation included 608 patients who, following IRBapproval, were randomized to receive multiple-doseintravenous bolus injection of HPβCD-diclofenac (n =318), ketorolac (n = 142), or placebo (n = 148) every 6hours post-surgery. Results: Overall, 8 renal AEsoccurred during the study period (3 each in the HPβCD-diclofenac and placebo groups, 2 in the ketorolac group),and all were mild or moderate in severity. In theHPβCD-diclofenac group, there was one incidence eachof hematuria, oliguria, and acute renal failure. Shifts tohigh creatinine or BUN were uncommon, and incidencesof shifts in these measures did not differ across treatmentgroups. Similarly, no differences were observed when

shift frequency was examined in subgroups based on age,procedure, or baseline renal function. Overall, changes inlaboratory values did not differ between patients receiv-ing HPβCD-diclofenac and placebo. Conclusions: Inthe study population examined, renal AEs and shifts inrelevant laboratory values were uncommon across treat-ment groups, with no apparent increase in incidence inpatients receiving HPβCD-diclofenac versus placebo.Funding: Studies reported were funded by Javelin Pharma-ceuticals Inc. (a subsidiary of Hospira Inc., Lake Forest, IL,USA, since 2010)

175The Relationship of High Perioperative NarcoticConsumption and Increased Incidence ofRecurrence of Non-Small Cell Lung CancerDermot Maher, MD, [email protected],Waylan Wong, MD MS1, Robert McKenna, MD1,Roya Yumul, MD PhD1, Vida Zhang, MD1, (1) CedarsSinai Medical Center, Los Angeles, CAEvidence suggests that narcotic sparing perioperativepain management techniques can impact long term sur-gical outcomes such as cancer free survival.1,2 The phe-nomenon is potentially due to the suppressive effects ofnarcotics on cell mediated immunity, especially naturalkiller cells.3,4 After obtaining IRB approval, the records ofconsecutive patients of a single thoracic surgeon (R.M.)who underwent a unilateral VATS lobectomy for Stage Ior II biopsy proven NSCLC were examined. Post-operative pain management was at the discretion of rotat-ing residents and fellows. Perioperative informationincluding was gathered including demographics, labora-tory data, surgical, anesthetic, nursing, and pharmacyreports. Narcotic doses were then converted to theequivalent dose of oral morphine. Data was then com-pared to the National Cancer Registry’s incidence ofrecurrence or disease-free survival for 5 years from thetime of diagnosis. 456 charts of patients seen between7/2006 and 5/2008 were analyzed. A total of 100 patientswere included in final analysis, 74 of whom were NSCLCfree at 5 years and 26 were found to have NSCLC recur-rence within 5 years. The average amount of narcoticreceived in the perioperative period was 168 mg of mor-phine for cancer-free group and 354 mg of morphine inthe recurrence group (p = .02) Intraoperative narcotic andhospital length of stay, and post-operative visual analogscale pain scores did not have a statistical relationship tocancer free survival. This retrospective study suggests arobust statistically significant association betweenincreased doses of narcotic during the perioperativeperiod and higher recurrence rates of NSCLC. Refer-ences: 1) Biki B, Mascha E, Moriarty DC, FitzpatrickJM, Sessler DI, Buggy DJ. Anesthetic technique for

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radical prostatectomy surgery affects cancer recurrence.Anesthesiology 2008;109:180–7. 2) Exadaktylos AK,Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Cananesthetic technique for primary breast cancer surgeryaffect recurrence or. Anesthesiology 2006;105:660–4. 3)Snyder GL, Greenberg S. Effect of anaesthetic techniqueand other perioperative factors on cancer. Br J Anaesth2010;105:106–15.Funding: None

176Relative Bioavailability Study of anAbuse-Deterrent Formulation of Extended-ReleaseOxycodone with Sequestered Naltrexone (ALO-02)Versus Immediate-Release Oxycodone Tablets inHealthy VolunteersBimal Malhotra, [email protected],Kyle Matschke, Candace Bramson, MD2, Qiang Wang,Joanne Salageanu, BS3, (1) Pfizer Inc, New York, NY,(2) Pfizer, Groton, CT, (3) ASCPT, Norwalk, CTIntroduction: ALO-02, an abuse-deterrent formulation,comprises capsules filled with pellets of extended-releaseoxycodone hydrochloride surrounding sequestered nal-trexone hydrochloride. This study compared oxycodonepharmacokinetics following ALO-02 (oxycodone/naltrexone 40/4.8 mg) versus immediate-release oxyco-done (IRO) tablets (20 mg). Methods: IRB-approved,open-label, single-dose, randomized, 2-way crossoverstudy in 14 healthy fasted adults (aged 18–55 years).Plasma concentrations of oxycodone, naltrexone, and6-β-naltrexol were determined. Maximum plasma con-centration [Cmax], area under the plasma concentration-time profile from time 0 to infinity [AUCinf] and to thelast quantifiable concentration [AUClast], time to Cmax[Tmax], and terminal half-life [t1/2] were determined.Adverse events (AEs) were recorded throughout thestudy. Results: Median oxycodone Tmax was prolonged(12 versus 1 hours) and mean t1/2 was longer (7.2 versus4.6 hours,) for ALO-02 versus IRO. ALO-02/IRO ratios(90% confidence intervals [CIs]) of adjusted geometricmeans for dose-normalized AUCinf and AUClast were107.2% (96.7%, 118.8%) and 106.1% (95.4%, 118.0%),respectively, with CIs contained within equivalence limitsof 80%–125%. Dose-normalized ALO-02/IRO Cmaxratio (90% CI) was 33.0% (28.8%, 37.9%). FollowingALO-02 administration, plasma naltrexone concentra-tions were below the limit of quantification (BLQ;4.00 pg/mL), and 6-β-naltrexol concentrations wereBLQ in >50% of participants or generally low (<50 pg/mL). Most AEs were mild, with nausea and dizzinessbeing most frequent. Conclusion: Pharmacokineticcomparisons indicate equivalent oxycodone bioavailabil-ity under fasted conditions. The lower Cmax and longerTmax and t1/2 observed for ALO-02 versus IRO are

consistent with its extended-release formulation. Low orBLQ plasma naltrexone and 6-β-naltrexol concentrationsindicate successful sequestration of naltrexone inALO-02.Funding: This study was sponsored by Pfizer Inc. Medicalwriting support for the development of this abstract was pro-vided by Vardit Dror, PhD, of Engage Scientific Solutions andfunded by Pfizer Inc.

177Effects of Ethanol on the Pharmacokinetics of anAbuse-Deterrent Formulation of Extended-ReleaseOxycodone Hydrochloride and NaltrexoneHydrochloride (ALO-02)Bimal Malhotra, [email protected],Kyle Matschke, Qiang Wang, Candace Bramson, MD2,Joanne Salageanu, BS3, (1) Pfizer Inc, New York, NY,(2) Pfizer, Groton, CT, (3) ASCPT, Norwalk, CTIntroduction: The study objective was to determineeffects of 20% and 40% ethanol on bioavailability ofoxycodone from ALO-02, an abuse-deterrent formula-tion comprising capsules filled with pellets of extended-release oxycodone hydrochloride surrounding analtrexone hydrochloride core. Methods: IRB-approved,open-label, single-dose, randomized, three-way cross-over study in 18 healthy fasting adults (age 18–55 years)to evaluate safety and pharmacokinetics of ALO-2 (oxy-codone 20-mg/naltrexone 2.4-mg) given with 20% or40% ethanol compared to water. Maximum plasma con-centration [Cmax], area-under-the-curve from time 0 toinfinity [AUCinf] or to last quantifiable concentration[AUClast], and time to Cmax [Tmax] were determined.Results: Median Tmax after administration of ALO-02with water (n = 17) or 20% ethanol (n = 18) was 12 hours,and 8 hours with 40% ethanol (n = 18). Ratios of adjustedgeometric means (90% confidence intervals [CIs]) foroxycodone AUCinf, AUClast, and Cmax were 96.8%(82.7, 113.3), 98.0% (84.2, 114.0), and 101.3% (87.3,117.4), respectively for ALO-02 with 20% ethanol versuswater, and 113.3% (97.2%, 132.0%), 115.0% (99.2%,133.4%), and 136.8% (118.5%, 158.0%), respectively forALO-02 with 40% ethanol versus water. The 90% CIswere contained within the 80%–125% bioequivalencelimits for 20% ethanol versus water but not for 40%ethanol versus water. Higher incidences of adverse events(vomiting, nausea, headache, and somnolence) werereported for ALO-02 taken with ethanol versus water andincreased with ethanol concentration. Conclu-sions: Oxycodone pharmacokinetics were unaffectedwhen ALO-02 was given with 20% ethanol, but there wasan approximately 37% and 13% increase in Cmax andAUCinf, respectively, with 40% ethanol.Funding: This study was sponsored by Pfizer Inc. Medicalwriting support for the development of the abstract was

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provided by Mary Kunjappu, PhD, of Engage Scientific Solu-tions and funded by Pfizer Inc.Conflicts of Interest: All authors are full-time employees andshareholders of Pfizer Inc.

178Unraveling the Complexity of Pelvic PainJohn S McDonald, MD, [email protected], Jichang Li,MD PhD1, Paul Micevych, PhD2, Andrea J Rapkin, MD2,(1) Harbor-UCLA Medical Center, Torrance, CA,(2) UCLA, Los Angeles, CAPrevious and even recent studies suggest syndromes suchas IBS are often comorbid with chronic pelvic pain inwomen. A possible explanation for this phenomena isvisceral-visceral cross-sensitization. This abstract is thecombined results of 5 years of both basic science and alsoapplied clinical research. Our intent was to examineresponses at the level of the dorsal root ganglion neurons(DRG) that subserve the visceral area; This area is rich ininnervation of various visceral targets for possible uncov-ering some of the mystery and mechanisms involvingchronic pelvic pain. DRG neurons were labeled by inject-ing fluorescences into the colonic and uterine walls.Inflammation was induced by injecting mustard oil intouterine lumen in rats. 1. The same DRG neurons inner-vated both the uterus and the colon in the rat. 2. Uterineinflammation increased immunoreactivity of pERK&Substance P in DRG neurons innervating both the uterusand the colon in the rat. 3. Rapid action estradiol in DRGneurons involves interaction with mGIuRs. 4. Resultssuggest visceral sensory integration in DRGs may under-lay comorbidity of chronic pelvic pain in women. 5. Thisstudy demonstrated some of the first evidence thatuterine inflammation can directly affect the colon; thusvisceral sensory integration in the DRG may underlie theobserved comorbidity of “female pelvic pain syndromes”or pain sharing in the pelvis. References: 1) Latthe P,Mignini L, Gray R, Hills R, Khan K. Factors predispos-ing women to chronic pelvic pain: systematic review.BMJ. 332:749–55, 2006. 2) Friedrich-Karl Pierau, GerdFellmer and David C. M.Taylor. Somato-Visceral Con-vergence in Cat Dorsal Root Ganglion Neurones Dem-onstrated by Double-Labelling With FluorescentTracers. Brain Research, 321: 63–70, 1984. 3) Guang-YinXu and Li-Yen Mae Huang. Peripheral InflammationSensitizes P2X Receptor-Mediated Responses in RatDorsal Root Ganglion Neurons. The Journal of Neuro-science, 22(1): 93–102, 2002.Funding: None

179Case Report: Recurrent Central Sensitization,Potential for Development of Chronic Pain andImportance of Preventive AnalgesiaFebin Melepura, [email protected], Anis Dizdarevic,MD2, (1) Columbia University Medical Center, New York,NY, (2) Columbia University, New York, NYThere is no universally established regiment to preventthe transition from acute to chronic pain. The transitionis thought to arise from maladaptive neuroplastic mecha-nisms, central sensitization being one of the more impor-tant. It is a phenomenon where the somatosensorynervous system remodels in response to insults, causing,among others, a secondary hyperalgesic state. We presenta case of recurrent central sensitization triggered byunrelated painful insults of different etiologies (headache,concussion, surgery). Pathophysiology, evolution, andmanagement of SC is discussed, as well as the role andimportance of appropriate preventive analgesia. A47-year-old female with a history of cluster headachespresented with acute worsening pain, accompanied withhyperesthesia and allodynia involving her mandible,neck, and clavicle, 1 week after an MVA. Patient alsodescribed previous episodes of intense headaches associ-ated with short lasting areas of hypersensitivity involvingvarious parts of the body. Patient was immediately startedon intense multimodal therapy and referred to PT. Threeweeks into the therapy, she reported gradual but definiteimprovement in her symptoms. In the interim, MRI ofthe head/neck, to follow-up on her previous CT scan,showed an intramedullary lesion at the C1-C2 level. Shewas promptly referred to neurosurgery and scheduled fortumor resection. Comprehensive perioperative painmanagement strategy was developed to avoid or mini-mize recurrence of her central sensitization. Surgery wasuneventful, and patient recovered well. One week post-operatively, she developed bilateral occipital neuralgiaand mild allodynia/hypersensitivity, which respondedwell to the adjusted pain management therapy employed.References: 1) McGreevy K, Bottros MM, Raja SN. Pre-venting Chronic Pain following Acute Pain: Risk Factors,Preventive Strategies, and their Efficacy. Eur J PainSuppl. 2011 Nov 11;5(2):365–372.2) Woolf CJ. Centralsensitization: implications for the diagnosis and treat-ment of pain. Pain. 2011 Mar;152(3 Suppl):S2–15. doi:10.1016/j.pain.2010.09.030. Epub 2010 Oct 18. 3) KehletH, Jensen TS, Woolf CJ. Persistent postsurgical pain:risk factors and prevention. Lancet 2006 May; 36: 1618–25.Funding: None

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182Novel Extended Release GabapentinRichard Rauck, MD, [email protected], James North,MD1, Kyung Soo Hong, MD2, (1) Carolinas Pain Institute,Winston-Salem, NC, (2) The Center for Clinical Research,Clemmons, NCWe assessed the efficacy and safety of Gralise® (gabapen-tin; Depomed, Inc. Newark, CA) in a 15-week, open-label, observational study in patients with fibromyalgia.Materials and Methods: For this open-label study, eli-gible patients included those who had previously triedand failed previous gabapentin and/or pregabalin therapy.Patients with autoimmune conditions or opioid use forfibromyalgia pain were excluded. Patients were titratedto,1800 mg over 2 weeks using the Gralise starter pack.After completion of titration, the dosage could be modi-fied (between 1,200 and 2,400 mg). At baseline, monthlyfollow-up visits, and the final Week 15 visit, patientscompleted the Fibromyalgia Impact Questionnaire(FIQ), Patient Global Impression of Change (PGIC),Medical Outcome Study Sleep Scale (MOS Sleep), andNumeric Pain Rating System (NPRS) instruments. Atthe end of treatment period, patients were graduallytapered off under physician supervision over 3 weeks.Results: Of 34 patients, 29 (88%) completed titrationand 17 (51%) completed the study. Twenty-one (62%)patients had prior exposure to gabapentinoids. Comparedwith baseline, after 15 weeks, patients reported improve-ment on both the FIQ and NPRS instruments 44%improvement on the FIQ, (71.0% vs. 39.3%) and 48%improvement on the NPRS (7.3 vs. 3.8). On the MOSsleep questionnaire, which asked patients to rate theirsleep patterns, patients also reported improvements frombaseline in sleep disturbance (64%), sleep adequacy(49%), somnolence (42%), and optimal sleep (54%).Conclusion: Treatment Gralise led to improvementsover baseline on three fibromyalgia impact question-naires (FIQ, PGIC, and NPRS) and improved sleepquality. References: 1) F. Wolf, HA. Smythe, MB. Yunus,RM. Bennett, C. Bombardier, DL. Goldenberg, et.al.The American College of Rheumatology 1990 criteriafor the classification of fibromyalgia: report of the Mul-ticenter Criteria Committee. Arthritis & Rheumatism.,1990; 33:160–172. 2) JI. Hudson, HG. Pope Jr., TheRelationship between fibromyalgia and major depressivedisorder [review]. Rheum Dis Clin North Am 1996;22:285–303,3) F. Wolf, K. Ross, J. Anderson, IJ. Russell,L. Herbert, The prevalence and characteristics of fibro-myalgia in the general population. Arthritis & Rheuma-tism, 1995; 38:19–28.Funding: Grant from DepoMed

183A Case of Adrenal Insufficiency Secondary toChronic Opioid Use—Keep this Diagnosis in Mind!Joseph Rabi, [email protected], (1) Schwab RehabilitationHospital/University of Chicago, Chicago, ILWith the increase use of opioids for chronic pain, theincidence of adrenal insufficiency is increasing; therefore,it is imperative that a pain physician recognize the clinicalsigns and symptoms of adrenal insufficiency and makeappropriate judgment for diagnostic work up and treat-ment. Opioid induced adrenal insufficiency should beclinically suspected in patients taking 100 mg of mor-phine equivalent for greater than 1 year if clinical symp-toms and signs are present. Clinical judgment should beused for diagnostic work up and treatment. Treatmentapproaches include opioid rotation, wean opioids,modalities/interventional pain techniques, and, if thesefail, steroid and hormonal supplements should be givento patients along with an explanation of the risks andbenefits. A case is presented of a 24-year-old female withsickle cell disease on morphine sulfate 90 mg dailyfor greater than 3 years who developed amenorrhea,hypotension, nausea and vomiting due to opioid endocri-nopathy causing adrenal insufficiency. The opioid endo-crinopathy symptoms resolved with opioid rotation andsteroid supplements. Further studies need to be done todetermine the incidence of opioid endocrinopathyand which opioids are more likely to cause opioidendocrinopathy.Funding: None

184Sublingual Sufentanil NanoTabs® for AcuteTraumatic Pain: A Randomized, Double-Blind,Placebo-Controlled, Phase 2 Dose Finding StudyMike Royal, MD JD MBA, [email protected],Mark Evashenk, BS1, Martha Neubauer, BA1,Pamela P Palmer, MD PhD1, (1) AcelRx Pharmaceuticals,San Diego, CAIntroduction: Sublingual sufentanil microtablet in asingle-dose applicator is in development for treatment ofpatients with moderate-to-severe acute pain in amedically-supervised setting where immediate IV accessis limited. When administered sublingually, Sufentanil’spharmacokinetic profile and noninvasive delivery makesit a useful alternative to IM or IV dosing. Materials andMethods: In a Phase 2, double-blind, dose-finding trial,patients were randomly assigned in a 2:2:1 ratio to Sufen-tanil NanoTabs (SN) 20 mcg or SN 30 mcg or placebo,respectively, following bunionectomy. Study drug wasdosed as needed but not more frequently than hourly.Rescue medication was available as needed. The primaryendpoint was the Summed Pain Intensity Difference tobaseline over 12 h (SPIDI2). Safety was assessed by con-

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tinuous oxygen saturation monitoring and adverse event(AE) reporting. Results: 101 patients (51M/50F) wererandomized, 100 received study treatment (intent-to-treat [ITT] population), and 91 completed the study.Reasons for early discontinuation were lack of efficacy(6), AEs (2) and drug-dosing error (1). For the ITTpopulation, SN 30 mcg was superior to placebo (p =0.003) for the SPID12 (Figure 1). Results for SN 20 mcgwere not significant. PID and PR scores at 30, 45 and60 min were all statistically significantly superior in favorof SN 30 mcg vs. placebo (p < 0.001 at each timepoint forboth measures). The most frequently reported AEs werenausea (39.0%), vomiting (17.0%), dizziness (14.0%),and somnolence (11.0%). Conclusion: The sublingualSufentanil NanoTab 30 mcg may be a promising non-invasive, rapid onset treatment for acute pain.Funding: US Army Medical Research and MaterialCommand; AcelRx Pharmaceuticals

186Safety Profile of Morphine Sulfate and NaltrexoneHydrochloride Extended-Release Capsules inOlder Patients: Pooled SafetyAnalysis from 3Clinical TrialsBeatrice Setnik, [email protected],Glenn Pixton, MS1, Lynn R Webster, MD2, (1) Pfizer Inc,Durham, NC, (2) CRI Lifetree, Salt Lake City, UTIntroduction: There are limited clinical trial safety datafollowing repeat administration of extended release (ER)opioids within an older population. Here we presentpooled data comparing safety outcomes for patients age≥65 years with those age <65 years from two blindedshort-term studies and one open, long-term trial in whichall patients were administered repeat doses of ER mor-phine sulfate + sequestered naltrexone (MSN). Materialsand Methods: Studies were conducted in accordancewith the provisions of the Declaration of Helsinki and itsamendments. Subgroup analysis of patients age ≥65 yearsand <65 years were performed on pooled data withrespect to demographics, adverse events (AE), clinicallysignificant laboratory values, and Clinical Opiate With-drawal Scale (COWS) score (phase 3 trials only) for allpatients who received at least one dose of study medica-tion during titration and maintenance phases. Safetyparameters were assessed up to 16 weeks post-MSN ini-tiation. Results: Of 1012 patients during titration, 173(17.1%) were age ≥65 years. Of 564 patients duringmaintenance, 76 (13.5%) were age ≥65 years. Commonopioid AEs were similar between the ≥65 and <65 yearsage groups respectively with the exception of headache(1.7% vs 8.0%), dizziness (10.4% vs 5.0%), and vomiting(15.6% vs 6.7%) during titration and constipation (5.3%vs 10.7%) and vomiting (1.3% vs 6.1%) during mainte-

nance. No clinically significant changes in laboratoryvalues or COWS scores were observed between agegroups. Conclusion: Safety outcomes following repeatadministration of MSN were similar in patients age ≥65years compared to those <65 years.Funding: Pfizer Inc.

187Combined Use of Oxytocin and Human ChorionicGonadotropin in Intractable Pain PatientsForest Tennant, MD, [email protected], (1) Veract Inc.,West Covina, CAIntroduction/Statement of the Problem: Oxytocin (OT)and human chorionic gonadotropin (HCG) have bothbeen reported to have neurogenic and analgesic proper-ties. They are likely responsible for the anecdotal reportsof pregnant women who report that their pain and/orneed for opioids declines at this time. Small, open-labeltrails indicate that each of these hormones may reducepain and opioid use in intractable pain patients. This isthe first trial to simultaneously administer both hor-mones. Materials and Methods: Nine (9) intractable painpatients maintained on one or more long- and short-acting opioids were selected. All gave informed consentapproved by the facilities Institutional Review Board.Dosage of HCG ranged from 250 to 500 units sublingualdaily and that of OT was 10 units sublingual taken 2 to 4times a day. Evaluation for pain relief, side-effects,energy, mental function, and opioid dose reduction wasdone at 2–3 months. Results: One patient reported noeffect and stopped the regimen. One patient stopped OTbecause it made her weepy and despondent, but she con-tinued HCG. All other patients reported a 30 to 40%reduction in opioid use, reduction in baseline pain, flareintensity, or increase in time between flares. Reports ofenergy, improved mental functions, mood, and libidowere variable. Conclusions: The very preliminary resultsobserved here are cause for further pursuit as most othertreatments for intractable pain are symptomatic.Funding: None

188Opioid Regimens in Intractable Pain Patients whoHave Multiple Cytochrome p450 DefectsForest Tennant, MD, [email protected], (1) Veract Inc.,West Covina, CAIntroduction/Statement of the Problem: Opioidmetabolism is greatly dependent upon the cytochromeP450 system. Some pain patients have multiple cyto-chrome defects, which likely affects choice of opioidregimen. Materials and Methods: Forty-nine (49) intrac-table pain patients were identified who have 2 or 3cytochrome defects. Testing consisted of assaying for

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cytochrome P450, 2D6, 2C9, and 2C19. A defect wasconsidered any determination (poor, rapid, intermediate)other than normal (extensive). Patients had settled on aneffective opioid regimen developed over time by trial anderror. All were initially referred because of non-responsiveness to standard, low dose opioid regimen.Chart review was done to determine the opioid regimenthat controlled the patient’s pain sufficient enough toallow activities of daily living and maintenance of normalblood pressure and pulse rate. Results: Patients main-tained on one or more of the following opioids: fentanyl(18; 30.7%); oxycodone (26; 53.1%); hydrocodone (5;10.2%); methadone (9; 18.4%); morphine (24; 49.0%);hydromorphone (26; 53.1%). Seven (7; 14.3%) requiredinjectable opioids as they did not respond to oral opioids.Conclusions: Although a treatment regimen is multifac-torial, patients here showed a propensity to use opioidsthat utilize either the cytochrome P450, 3A4 enzyme or anon-cytochrome, metabolic pathway (most likely glu-coronidation). A small percentage of patients requiredinjectable opioids likely because cytochrome P450enzymes are ubiquitous in the intestine and liver and arerequired for gastrointestinal absorption.Funding: None

189Comparison of the Effect of Post-OperativeOpioids on Respiratory Status in GeneralAnesthesia and Spinal Anesthesia Patients Using aNon-Invasive Respiratory Volume MonitorChristopher Voscopoulos, MD, [email protected],Diane Ladd, DNP2, Eamon Fleming, BS3, KathleenCampbell, BA3, Edward George, MD PhD4, (1) Brighamand Women’s Hospital, (2) Respiratory Motion, Inc.,Waltham, MA, (3) Respiratory Motion, Waltham, MA,(4) Massachusetts General Hospital, Boston, MAIntroduction: Post-operative management after eithergeneral or spinal anesthesia (GA/SA) frequently includesopioids that can cause respiratory depression, includingopioid-induced-respiratory-depression (OIRD) and post-operative-apnea (POA). This study utilized respiratorytraces and minute ventilation (MV) measurements from anon-invasive Respiratory Volume Monitor (RVM) toevaluate opioid effect on respiratory status in GA and SApatients in the PACU. Methods: RVM data were col-lected from 114 orthopedic patients (GA:21, SA:93).50/114 patients received opioids in the PACU (GA:12,SA:38). “Predicted” MV (MVPRED) and “Percent-Predicted” MV (MVMEASURED /MVPRED x100%) were cal-culated for each patient. Patients were classified as POA(>5 apnea/hypopnea events/hour) and/or as “Un-Safe”(MV < 40% MVPRED after the first opioid dose; MV < 40%MVPRED > 1/3 of the 30 minutes before discharge).Results: Fewer SA patients received opioids (41% SA vs.

57% GA, p > 0.2) and had a lower morphine-equivalentdose (5.6 ± 0.8 mg, SA vs. 6.6 ± 1.2 mg, GA, p > 0.2).Following opioid, OIRD in the SA group was 2-foldhigher (34% SA vs. 17% GA, p < 0.05), while POA wassimilar (26% SA vs. 33% GA, p > 0.2). In patients notreceiving opioids, 13% (7/55) SA patients were classifiedas “un-safe” prior to discharge compared to 0% (0/9) GApatients, p < 0.01. Conclusions: RVM provides non-invasive real-time respiratory traces and MV measure-ments which quantify the effect of opioids, OIRD, andPOA. Patients receiving SA were shown to be at risk forrespiratory depression, and like GA patients, need carefulmonitoring. These results may be skewed because patientswith higher risk for respiratory compromise may havebeen selected for SA. Further investigation is planned.Funding: None

190Oral Baclofen for Generalized Pain Control in aChild with Mitochondrial Complex III DeficiencyRehan Waheed, MD, [email protected],Harry Webster, MD1, Saniya Merchant, BS2, (1) TuftsMedical Center, Boston, MA, (2) Tufts University School ofMedicine, Boston, MAIntroduction: Mitchondrial Complex III Deficiency, orUbiquinone-cytochrome c oxidoreductase deficiency,occurs in four major forms. One of these forms includessymptomatic myopathy with exercise intolerance thateventually evolves into fixed weakness. Additionally,patients often complain of generalized pain that is diffi-cult to control with standard pain regimens. This hasunfortunately led to increased opioid and benzodiazepineusage in children with mitochondrial disorders withfurther complications of addiction. Case Descrip-tion: Patient is a 15-year-old female with mitochondrialcomplex III deficiency who presented with complaints ofgeneralized lower back pain of several months duration.Imaging resulted negative for acute processes. In the pre-vious 2 months, patient reported taking increasing dosesof diazepam for relaxation and pain relief. This regimenwas self-prescribed due to its immediate effect; however,patient wished to discontinue this practice as familyunderstood the possible sequellae of benzodiazepineabuse. Patient was prescribed oral baclofen to start at5 mg BID dosing with 5 mg uptitration q7days. Atfollow-up, the patient reported good effect with thisregimen without need to use diazepam for breakthroughpain relief. Discussion and Conclusions: Baclofen is aknown synthetic GABA agonist with beneficial effects onmuscle spasm and related pain symptoms that has beenwell documented. However, the effect of baclofen in gen-eralized pain syndromes found in pediatric mitochondrialdisorders is still unknown. We argue that this casedemonstrates a need for an expanded role of baclofen for

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these patients as successful pain reduction and a discon-tinuation of addictive adjunctive medications wasachieved. References: 1) Hernández-Beltrán N, MorenoCB, Gutiérrez-Álvarez AM. Contribution of Mitochon-dria to Pain in Diabetic Neuropathy. Endocrinol Nutr.2013 Jan;60(1):25–32.Jan;60(1):25–32. 2) Moyer V,Elliott E. Evidence Based Pediatrics and Child Health2004; pp475–477. 3) Braddom R, et al. Carotid Disease:Physical Medicine and Rehabilitation 2007; pp646–648.Funding: None

191Pharmacokinetic (PK) and Pharmacodynamic (PD)Interactions Between Buprenorphine TransdermalSystem (BTDS) and Midazolam in Healthy SubjectsYi Wang, [email protected], Catherine Munera, PhD1,Stephen Harris, MD1, (1) Purdue Pharma L.P., Stamford,CTIntroduction: Concomitant administration of buprenor-phine and benzodiazepines has occasionally been associ-ated with respiratory depression. This study investigatedeffects of BTDS and midazolam, a benzodiazepine, onPK/PD measures in healthy subjects. Materials andMethods: This was a double-blind, double-dummy,IRB-approved trial of healthy subjects (N = 36) random-ized to receive midazolam 1 mg IV (Day 6) in addition to7-day treatment with either BTDS (10 mcg/h), fentanyltransdermal system (TDS, 25 mcg/h), or placebo.Buprenorphine, midazolam, and fentanyl PK was evalu-ated. PD evaluations included SpO2, respiratory rate,blood pressure, and pulse rate. Safety measures includedclinical chemistries, vital signs, ECGs, and adverse events(AEs). Buprenorphine and fentanyl PK metrics beforeand after midazolam, and midazolam PK metrics in eachof the 3 treatments were compared using ANOVA and90% CIs. Results: There were no statistical differencesin midazolam exposure across the 3 treatments.Buprenorphine AUCt was similar before and after mid-azolam administration, but Cmax was significantly lowerafter midazolam administration. Both fentanyl Cmax andAUCt were significantly lower after midazolam adminis-tration. Mean values for all PD variables generallyremained within the reference range. No changes inSpO2 or vital signs met AE criteria. The effect of BTDSwith concomitant midazolam on SpO2 (assessed as thefrequency of measures below 94%) was similar to that offentanyl with concomitant midazolam, and both werenumerically higher than placebo. Conclusion: BTDSand fentanyl TDS co-administered with midazolam 1 mgIV produced no clinically meaningful effect on respira-tory depression compared with placebo, or each other, inhealthy subjects.Funding: The study was sponsored by Purdue Pharma L.P.

192The Responsiveness to Treatment of theNeuropathic Components of Knee Osteoarthritisand the Use of Quantitative Sensory Testing (QST)to Predictor Responders and Non-Responders toDiclofenac GelAjay D Wasan, MD MSc, [email protected],Rob Edwards, PhD2, (1) University of Pittsburgh,Pittsburgh, PA, (2) Brigham and Women’s Hospital,Chestnut Hill, MAIntroduction: It is unknown if the painful neuropathicsymptoms and processes in knee OA respond toNSAIDs or predict treatment responses. We hypoth-esized that in using topical diclofenac gel, neuropathicsymptoms would be prevalent and responsive totherapy, and that measures of pain sensitivity and painmodulation would predict treatment responses.Methods: After obtaining written consent and IRBapproval, we conducted a five-week effectiveness studyof diclofenac gel in 44 patients with knee OA. Patientswere extensively phenotyped, including the use of theNeuropathic Pain Questionnaire (NPQ), the KneeInjury and Osteoarthritis Outcome Score (KOOS, amultidimensional pain and functional assessment), anexercise performance task, and quantitative sensorytesting (QST). Results: 40% of the 38 study completershad significant neuropathic symptoms (burning, shoot-ing, or sensitivity to touch, mean 35/100), and thesewere moderately correlated to measures of pain sensi-tivity with QST at baseline (.4-.50, p < .01). The cohorthad on average 30% improvement in pain over 4 weeksof treatment, including an equal response in those withneuropathic symptoms (p < .01), and improved function(self-rated and measured, p < .01). Baseline conditionedpain modulation (CPM; an index of endogenous pain-inhibitory capacity calculated from QST measurements)was prospectively associated with changes in pain inten-sity and changes in neuropathic symptoms (p < .05).Subjects with higher CPM at baseline (better function-ing endogenous pain-inhibitory systems) showed morereduction in pain intensity and neuropathic pain symp-toms at study end (p < .05). Conclusions: In NSAIDtreatment of OA, NP is prevalent and responsive totreatment, and QST measures can predict treatmentresponders and nonresponders. References: 1) Lin J,Zhang W, Jones A, Doherty M. Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment ofosteoarthritis: meta-analysis of randomised controlledtrials. BMJ. 2004;329:324. 2) Maier C, Baron R,Tolle TR, Binder A, Birbaumer N, Birklein F, et al.Quantitative sensory testing in the German ResearchNetwork on Neuropathic Pain (DFNS): somatosensory

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abnormalities in 1236 patients with different neuro-pathic pain syndromes. Pain. 2010 Sep;150(3):439–50.Funding: An investigator initiated study from EndoPharmaceuticals

193Abuse Quotient of Orally Administered MNK-795Extended-Release Oxycodone/Acetaminophen (XROC/APAP) Tablets Versus Immediate-ReleaseOxycodone/Acetaminophen (IR OC/APAP) Tabletsin Recreational Users of Prescription OpioidsLynn R Webster, MD, [email protected],Terri Morton2, Kenneth Kostenbader, MD2,Jeannie Montgomery, RN2, Krishna Devarakonda2,Thomas J Barrett, PhD2, (1) CRI Lifetree, Salt LakeCity, UT, (2) Mallinckrodt Inc., Hazelwood, MOIntroduction: The abuse quotient (AQ; peakconcentration/time to peak concentration [Cmax/Tmax]) ofopioids is believed to be an important determinant ofabuse potential.1–5 Materials and Methods: A random-ized, double-blind, double-dummy, active- and placebo-controlled, crossover study compared the abuse potentialof XR OC/APAP with IR OC/APAP in non-dependent,recreational opioid users. Institutional review boardapproval and informed consent were obtained beforepatient enrollment. During each treatment period, 61subjects received 1 of 7 study drugs in randomized order:lower-dose XR OC/APAP (15 mg OC/650 mg APAP),higher-dose XR OC/APAP (30 mg OC/1,300 mg APAP),lower-dose IR OC/APAP (15 mg OC/650 mgAPAP), higher-dose IR OC/APAP (30 mg OC/1,300 mgAPAP), crushed higher-dose XR OC/APAP, crushedhigher-dose IR OC/APAP, or placebo. For each condi-tion, the AQ was determined and plotted against peakchanges in effect (Emax) for participant-reported effectsthat have been associated with abuse (drug liking, drughigh, and good drug effects).6–8 Results: The mean AQwas lower for both low-dose (4.77) and high-dose XROC/APAP (11.83) than low-dose (27.27) or high-dose(52.50) IR OC/APAP. Crushing reduced the AQs of IROC/APAP by 29.5% and XR OC/APAP by 23.1%. TheAQ correlated strongly with the Emax for drug liking (R2 =0.8716), drug high (R2 = 0.8869), and good drug effects(R2 = 0.8874). For all participant-reported effects, Cmax

correlated more strongly to Emax than did AQ. Conclu-sions: The AQ was strongly correlated with the pharma-codynamic participant-reported drug effects that havebeen associated with abuse and suggests that XROC/APAP has lower abuse potential than IR OC/APAP.References: 1) Webster LR, Bath B, Medve RA. Opioidformulations in development designed to curtail abuse:who is the target? Expert Opin Investig Drugs.2009;18(3):255–263. 2) Katz N, Dart RC, Bailey E,

Trudeau J, Osgood E, Paillard F. Tampering with pre-scription opioids: nature and extent of the problem,health consequences, and solutions. Am J Drug AlcoholAbuse. 2011;37(4):205–217. 3) Raffa RB, Pergolizzi JV,Jr. Opioid formulations designed to resist/deter abuse.Drugs. 2010;70(13):1657–1675.Funding: Technical editorial and medical writing support forthe development of this abstract was provided by AdrienneDrinkwater, PhD, Synchrony Medical Communications,LLC, West Chester, PA. Funding for this support was providedby Mallinckrodt Inc., Hazelwood, MO.

194Opioid-Induced Constipation (OIC) ImpactsPain ManagementCatherine Datto, MD MS, [email protected], Robert J LoCasale, PhD MS1, Chris Sexton, PhD2,Mark Sostek, MD1, Karin S Coyne PhD MPH2,(1) AstraZeneca, Wilmington, DE, (2) Evidera,Bethesda, MDPurpose: To describe how opioid induced constipation(OIC) affects pain management among chronic non-cancer pain patients. Methods: Patients on daily opioidtherapy for ≥4 weeks for chronic non-cancer pain withOIC were recruited into a prospective longitudinal studyconducted in the US, Canada, Germany, and the UK toassess the burden of OIC. Data from the baseline surveycompleted on October 3, 2013 are presented here.Results: 500 patients completed the baseline surveywhere 62% were female and 85% caucasian. Employ-ment status most commonly identified were unable towork - disabled (34.5%), retired (20.9%), and full-timeemployed (19.1%). Chronic lower back and joint painwere most frequently reported pain conditions (77% and52% respectively). 23.9% of patients reported <2 years ofopioid therapy. Seventy percent of patients reported 1.4spontaneous bowel movements per week over the last 2weeks. Concern about the need to change/reduce painmedicine was a common reason (13.1%) patients pro-vided for not speaking to doctor about constipation.Constipation resulted in moderate or complete interfer-ence with pain control in 48.8% of patients. As such,proportion of patients experiencing constipation symp-toms and inadequate response to laxatives increased aslevel of interference increased. Patients adjusting theirpain medication in prior week to have a bowel movementreported their pain became worse as result (46%). Theproportion of these patients experiencing more pain wasgreater in those with <2 years of opioid duration. Con-clusions: OIC significantly impacts pain management innon-cancer patients. Significant unmet needs remain inthis patient population.Funding: AstraZeneca

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195The Relationship Between Positive SubjectiveMeasures in Abuse Liability Studies andReal-World Nonmedical Use: Potential Impact ofAbuse Deterrent Opioids on Rates of NonmedicalUse and Associated Healthcare CostsAlan White, [email protected], Joseph LeCates,PhD1, Wendy Cheng, PhD1, Howard G Birnbaum, PhD1,Carl L Roland, PharmD MS2, David Schaaf, MD2,Jack Mardekian, PhD2, (1) Analysis Group, Inc., Boston,MA, (2) Pfizer, Inc., Apex, NCIntroduction: Human Abuse Liability studies (HALS)have demonstrated that abuse-deterrent opioid formula-tions (ADFs) reduce positive subjective measures (e.g.,“drug-liking” and “drug-high” when tampered comparedto non-ADFs. This study aimed to quantify the potentialimpact of these reductions on real-world nonmedical use(NMU, use without prescription or for the producedfeeling) rates and associated healthcare costs. Materials/Methods: Bipolar positive subjective endpoints “overalldrug-liking,” “in-the-moment drug-liking” and “drug-high” Emaxs (Peak Effects) were recorded from 15 pub-lished HALS. NMU data were obtained from the 2010NSDUH and DAWN surveys. Multivariate regressionsevaluated the association between the endpoints andNMU rates, controlling for prescription volume andindicators for opioids and controlled substance schedule.A published budget-impact model of ADFs was used toassess healthcare cost impacts. Results: Linear regres-sions show that a 5-point reduction in overall drug-liking/in-the-moment drug-liking/drug-high Emax wasassociated with a 0.36/0.38/0.23 (standard errors: 0.13/0.19/0.11) percentage point decrease in the NSDUHlifetime NMU rate. That decrease yields a 17.7/16.5/10.4-% reduction compared to the samples’ overallNMU rates of 2.04/2.30/2.26-%. Sensitivity analysesusing DAWN data and nonlinear functional forms wereconsistent with these results. These reductions were asso-ciated with private payer cost reductions of $64.6/60.2/37.8 million. Conclusions: Reductions in drugs’ positivesubjective measures were significantly associated withreduced real-world NMU and healthcare costs. A 5-pointreduction in two measures was associated with NMU ratereductions exceeding the White House target goal of15%. Given the link between NMU and abuse, ADFs’reduced positive subjective measures have potential toreduce abuse and associated costs. References: 1) Katz,N (2009). “Clinical Studies of Abuse Deterrent OpioidAnalgesics: Definitions, Current Approaches, and Criti-cal Issues,” Presentation at IMMPACT X, Arlington, VA,3 June 2009. 2) Schoedel, K, M Shram, et al. (2012).“Defining Clinically Important Differences in SubjectiveAbuse Potential Measures,” Presentation at 74th Annual

Meeting of the College on Problems of Drug Depen-dence, Palm Springs, CA, 14 June 2012. 3) White, A, HBirnbaum, D Rothman, N Katz (2009). “Development ofa Budget-Impact Model to Quantify Potential CostSavings from Prescription Opioids Designed to DeterAbuse or Ease of Extraction,” Applied Health Economicsand Health Policy 7(1): 61–70.Funding: Financial support for the study was provided byPfizer, Inc., which also participated in the study development,interpretation of data, review, and approval of the abstract.

228Study Investigating a Genetic Dependence RiskIndex of Variants Effect on Risk for Co-morbidPsychiatric Disorders among Chronic PainPatients (D.R.I.V.E.)Tobore Onojighofia MD1, Brian Meshkin BA1, DanielSchwarz MD1, Bilikis Akindele, MD MMCi1, G Smith,MD, Timothy Deer MD2, Lynn Webster MD3,A Zoleikhaeian4, Michael Hua, BS4, John Hubbard, PT4,Sherman Chang, PhD4, (1) Proove Bio-sciences Inc, Fulton,MD, (2) Center for Pain Relief, Inc, Charleston, WV,(3) CRILifetree, Salt Lake City, UT, (4) Proove Bio-sciencesInc, Irvine, CAIntroduction: Addiction to prescription opioid medica-tion is a serious problem that many patients face. Manydoctors prescribe opioid medications with little knowl-edge of the likelihood of addiction in individual patientsor groups. Patients with co-morbid psychiatric disorderspresent a substantial risk factor for misuse of prescriptionopioid medications. Materials & Method: The studyevaluated 287 patients across 27 clinical research sites. 76of these had co-morbid psychiatric disorders while 211did not. The most frequently occurring psychiatric dis-orders among subjects were Chronic Pain Syndrome (n =33) and Prescription Drug Dependence (n = 28). Otherpsychiatric disorders included anxiety, mononeuritis ofupper limb and multiplex, cerebral degenerations, auto-nomic nervous disorders, and trigeminal nerve disorders.Patients were genotyped for Dependence Risk IndexRatio (DRI) with TaqMan SNP genotyping assays usingthe proprietary Proove Narcotic Risk Genetics ProfileTest. Result: Setting a cut-off point of 18 for the DRI(between 12 and 36), 52 of the 76 (68.4%) patients withdiagnosed co-morbid psychiatric disorder had DRI ≥18.153 of 211 (72.5%) patients without a diagnosedco-morbid psychiatric disorder had DRI ≥ 18. From theresult it can be inferred that patients with chronic painwho have a DRI ≥ 18 may be 50% more likely(50% PPV) to be at greater risk of having a co-morbidpsychiatric disorder (68% sensitivity, 27.5% specificity, pvalue < 0.000000052) than those with a DRI below18. Conclusion: From this study, a genotype may be

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predictive of a co-morbid psychiatric disorder which ispredictive of risk the of narcotic/opioid dependence.Funding: Proove Biosciences, Inc., Irvine, CA

Psychosocial/Rehabilitation

198The Complex Regional Pain Syndrome (CRPS)Severity Score: Does Disease Severity ReflectGlobal Impression of Change or DisabilityDue to Pain?Jaya Agnihotri, [email protected], Maxine M Kuroda,PhD MPH2, R Norman Harden, MD1,(1) Rehabilitation Institute of Chicago, Chicago, IL; Collegeof Biological Sciences, University of Minnesota, Minneapolis,Minneapolis, MNIntroduction: CRPS comprises characteristic, thoughchangeable, sensory, vasomotor, sudomotor, and motor/trophic disturbances typically in an upper or lower limb.Pain in the affected area is disproportionate in time ordegree to the usual course of known trauma or othercause. These features of CRPS have been incorporatedinto a clinically feasible CRPS Severity Score (CSS),anticipated to be useful in monitoring treatment courseand identifying novel treatment options. One objective ofthis ongoing study is to evaluate the association of CSSwith level of disability due to pain. Materials andMethods: Patients seen by pain medicine specialists andmeeting the 2011 IASP diagnostic criteria (Budapest) forCRPS are enrolled at 8 international centers under site-specific IRB approvals. The MPQ-SF (VAS) and PainDisability Index (PDI, interference with normal activi-ties) are administered at the baseline and 3-month visits;Patient’s Global Impression of Change (PGIC) isobtained at the 3-month visit. Results: For 73 patientswith CRPS, total CSS was lower for those who reportedimprovement on PGIC and higher for those whoreported no change, or worsening, on PGIC at the3-month visit. Similarly, VAS was lowest for patients whoreported improvement on PGIC (27 ± 18), and rose forthose who reported minimal/no change (51 ± 20) orworsening on PGIC (83 ± 16) (p < .01 for adjusted groupdifferences). However, in a multivariable regressionanalysis, lessened pain and improved PGIC, but not CSS,predicted lower PDI. Conclusion: Disability associatedwith CRPS may be ameliorated to a greater extent withpain reduction than by lessening the other physical dis-turbances that often accompany CRPS. References: 1)Harden RN, Bruehl S, Perez RSGM, Birklein F, MarinusJ, Maihofner C, Lubenow T, Buvanendran A, Mackey S,Graciosa J, Mogilevski M, Ramsden C, Chont M, VatineJ-J. Validation of proposed diagnostic criteria (the “Buda-pest Criteria”) for complex regional pain syndrome. Pain2010;150(2):268–74. 2) Melzack R. The short-form

McGill Pain Questionnaire. Pain 1987;30(2):191–7.3) Farrar JT, Young Jr JP, LaMoreaux L, Werth JL, PooleRM. Clinical importance of changes in chronic painintensity measured on an 11-point numerical pain ratingscale. Pain 2001;94(2):149–58.Funding: None

199Examining Neuropsychological Sequelae ofChronic Pain and the Effect of Immediate-ReleaseOral Opioid AnalgesicsCady Block, MS, [email protected],Leanne R Cianfrini, PhD2, Juliette Galindo, MA2,(1) University of Alabama at Birmingham, Hoover, AL,(2) The Doleys Pain Clinic; University of Alabama atBirmingham, Birmingham, ALIntroduction: Patients commonly complain of subjectiveside effects of opioid use, such as forgetfulness, confusion,and sedation, which have caused concern about cognitiveimpairment. However, research on the effects of opioidson objective cognitive performance is still equivocal, andmany of the studies in support of opioid-related impair-ment do not fully account for the neuropsychologicaleffects of chronic pain. To that end, we sought to examinewhether 1) chronic nociceptive pain itself results inobjective neuropsychological impairment and 2) stableuse of immediate-release opioid analgesics amelioratesthe impairment in our first hypothesis through relievingpain intensity. Methods: 90 participants in 3 groups: 30individuals with no chronic pain/opioid use; 30 individu-als with chronic pain/no opioids; and 30 individuals withchronic pain treated with immediate-release oral opioids.Participants completed a one-time neuropsychologicalevaluation. Results: Findings included statistically sig-nificant effects of chronic pain on commission error, F (2,86) = 3.33, p < .05, partial n2 = .07, and short delayauditory verbal recall, F (2, 89) = 3.42, p < .05, partial n2

= .08, scores. Results were observed despite statisticallycontrolling for the effects of depression, concomitantmedication use, and demographics. However, these effectsizes are small and thus lacked clinical significance. Nosignificant effects of opioid analgesics were observed onneuropsychological function. Discussion: Chronic painresulted in small but statistically significant changes inattentional control, though these changes are not mean-ingful enough to be considered clinically significant. Noopioid effect was observed on participants’ neuropsycho-logical function.Funding: Teva Pharmaceuticals

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200Predicting Faking Good in Patients in TreatmentFor Chronic PainDaniel Bruns, [email protected],Tina A Disorbio, EdD2, Alexander Bruns, BA1,Dawn M Jewell, PsyD3, (1) Health Psychology Associates,Greeley, CO, (2) Private Practice, Evergreen, CO,(3) Health Psychology Associates, PC, Colorado Springs, COIntroduction: Chronic pain patients (CPPs) sometimesminimize both physical and psychological symptoms andmay even consciously fake good (FG). The motives forFG include that some patients may seek to conceal infor-mation out of embarrassment, stoicism, seeking toimprove their access to employment, or of wanting toavoid the stigma of mental illness or disability. Materialsand Methods: The Battery for Health Improvement 2(BHI-2) profiles and other variables were gathered from50 patients who were asked to fake good (FG). Addition-ally, 50 CPP were chosen at random from 346 patientswho were in treatment for chronic pain. Logistic regres-sion procedures were used to test BHI 2 scale scores aspotential predictors of faking status. Results: Variablespredicting CPP vs FG were the BHI 2 scale Defensive-ness and Pain Complaints. This produced a regressionequation that accounted for 65% of the variance betweenthe groups (Naglekerke R square = .646), led to thecorrect prediction of faking status 83% of the time, andwas statistically significant (Omnibus Test of ModelCoefficients p = .000). Conclusions: In this study,patients with FG status exhibited significantly differentpsychological profiles on their BHI 2 profiles as com-pared to CPPs, and these differences could be detectedpsychometrically. This finding may have clinical utility.FG status is often overlooked in the clinical setting, butidentifying patients who are positively biasing the infor-mation that they are presenting or conditions that thepatient is concealing or minimizing are more likely toreceive effective treatment. References: 1) Kunz M,Chen JI, Lautenbacher S, Vachon-Presseau E, RainvilleP. Cerebral regulation of facial expressions of pain. TheJournal of neuroscience. Jun 15 2011;31(24):8730–8738.2) Bruns, D., & Disorbio, J.M. (2003). Battery for HealthImprovement 2 Manual. Minneapolis: Pearson.Funding: None

201Predicting Faking Bad in Patients in Treatment forChronic PainDaniel Bruns, [email protected],Tina A Disorbio, EdD2, Dawn M Jewell, PsyD3,Alexander Bruns, BA1, (1) Health Psychology Associates,Greeley, CO, (2) Private Practice, Evergreen, CO,(3) Health Psychology Associates, PC, Colorado Springs,COIntroduction: Chronic pain patients (CPPs) sometimesmagnify both physical and psychological symptoms andmay even consciously fake bad (FB). Research suggeststhat FB is relatively prevalent in settings where the mag-nification of symptoms allows the patient to gain access toopioid or other medications, disability benefits, or socialattention. Materials and Methods: The Battery ForHealth Improvement 2 (BHI-2) profiles and other vari-ables were gathered from 50 patients who were asked tofake bad (FB). Additionally, 50 CPP were chosen atrandom from 346 patients who were in treatment forchronic pain. Logistic regression procedures were used totest BHI 2 scale scores as potential predictors of FBstatus. Results: Variables predicting CPP vs FB were theBHI 2 Symptom Dependency, Borderline, FunctionalComplaints and Muscular Bracing scales. A combinationof these predictors produced a regression equation thataccounted for 56% of the variance between the groups(Naglekerke R square = .564), led to correct prediction ofFB status 82% of the time, and was statistically significant(Omnibus Test of Model Coefficients p = .000). Conclu-sions: In this study, patients with FB status exhibitedsignificantly different psychological profiles on their BHI2 profiles as compared to CPPs, and these differencescould be detected psychometrically. This finding mayhave clinical utility. FB status increases the risk of over-treatment or compensation for medical conditions thatare not objectively present. The determination of FBstatus can help to provide for appropriate care in thosewith objective conditions and reduce the risk of iatro-genic complications. References: 1) Rohling, M. L., et al.(1995). “Money matters: A meta-analytic review of theassociation between financial compensation and the expe-rience and treatment of chronic pain.” Health Psychol14(6): 537–547. 2) McCullumsmith, C. B. and C. V. Ford(2011). “Simulated illness: the factitious disorders andmalingering.” Psychiatr Clin North Am 34(3): 621–641.3) Bruns, D. and J. M. Disorbio (2009). “Assessment ofbiopsychosocial risk factors for medical treatment: a col-laborative approach.” J Clin Psychol Med Settings 16(2):127–147.Funding: None

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202Functional Restoration in Active Duty ServiceMembers: Initial Outcomes in Pain, Function andOpioid UtilizationJeffrey M Tiede, MD, [email protected],Mary Ellen Earwood, MD1, Kenneth A Teuton, PharmD1,(1) Dwight D Eisenhower Army Medical Center, FortGordon, GAIt is important that service members are treated in amultidisciplinary setting with interprofessional assess-ment and treatment (Lew, 2009). Increasing levels dis-ability and prescription drug misuse are critical concernsto the DOD (Jeffrey, 2013). Civilian functional restora-tion programs have proven to be effective in difficultpatient populations (Gagnon, 2013). We started a pilotprogram, the Intensive Outpatient Program (IOP) atEisenhower Army Medical Center. Like civilian pro-grams, we focus on physical and behavioral interventions.However, unlike civilian programs, we emphasize a highlevel of physical training to ensure the service membercan return to military demands. Material/Methods: Thisis a retrospective analysis of PI data. Results will beupdated in an ongoing fashion. Service members arephysically active in rigorous exercises approximately15 hrs/week. Highlights include strict adherence to mili-tary structure and discipline, integration of Army Values,simulated Soldier Skills with occupational therapy, andincorporation of complementary and alternative medi-cine. Demographics: We present data from 103 servicemembers. Age varies from 19 to 55, rank varies from E-3(private first class) to O-5 (Lieutenant Colonel). Etiologyof pain varies with lumbar spondylosis, cervical spondy-losis and myofascial pain syndrome being common.Results: Here we present generalized outcomes for pain,function, and satisfaction. Average NRS-11 decreasedfrom 6.3 to 2.4. Army Physical Fitness Test pass rate54%. The SM’s Commands were asked about SM per-formance. 74% reported much improved/improvedability to perform duty to standard and 84% reportedmuch improved/ improved service member readiness.References: 1) Gagnon, C. (2013). Treatment Outcomesfor Workers Compensation Patients in a US-Based Inter-diciplinary Pain Management Program. Pain Practice,282–288. 2) Jeffrey, D. (2013). Prescription Drug MisuseAmong U.S. Active Duty Military Personnel: a Second-ary Analysis of the 2008 DoD Survey of Health RelatedBehaviors. Military Medicine, 180–195. 3) Lew, H.(2009). Prevalence of chronic pain, posttraumatic stressdisorder, and persistent postconcussive symptoms inOIF/OEF veterans: Polytrauma clinical triad. Journal ofRehabilitation Research and Development, 697–702.Funding: None

203Predictive Value of Psychosocial Factors in Hipand Knee Arthroplasty—A Prospective ClinicalStudy with 8 Years Follow-UpCarina Gerigk, [email protected],Haili Wang1, Andreas Werber1, Marcus Schiltenwolf, PhD1,(1) University Hospital Heidelberg, Heidelberg, DEUObjective: The major objective of our prospective 8-yearfollow-up study is to determine predictive factors(sociodemographic, pain, psychosocial) on the success(postoperative pain and satisfaction with the operation) ofelective orthopaedic joint surgery. A further minor objec-tive is to compare pain related outcome within certainelective orthopaedic joint surgery. Methods: Data wasobtained from the orthopaedic center in Heidelberg frompatients undergoing THA (total hip arthroplasty), TKA(total knee arthroplasty), meniscal repair of the knee, andhallux valgus corrective surgery. 260 patients wererecruited during the years 2005–2006, followed up until2009 and finished at 2013. Preoperative data (sociodemo-graphic data, pain parameters and pain location, psycho-social parameters) and follow-up data (pain parameters,satisfaction with the previous surgery, psychosocialparameters) were collected by using questionnaires andthe PHQ-D (Patient Health Questionnaire in theGerman version). Descriptive statistics and logisticregression analyses were computed. Results: At baselinethe sample consisted of 260 patients, the mean age being59 years. 86 patients had THA, 71 underwent TKA, 58had arthroscopic meniscal repair, and 45 patients hadhallux valgus corrective surgery. Within the four groupsof surgery, meniscal repair surgery (OR = 3,8/CI = 1,5-9,5/ p = .005) and hallux valgus correction (OR = 6/CI =2,1-16,7/p = .001) were significantly associated with a 3.8/6.0 higher risk for postsurgical pain than THA. Conclu-sion: Presurgical intense pain, major depression, somati-zation, and panic disorder predict postoperative painwithin an 8-year follow-up period. Preoperative screen-ing of psychopathological symptoms and potential pre-operative therapy of patients could prevent postoperativepain and failure of elective surgery. References: 1) Prof.Dr. Marcus Schiltenwolf. 2) Dr. Haili Wang. 3) Dr.Andreas Werber.Funding: None

204Bisphosphonate-Related Osteonecrosis of theJaw/TMJ Presenting as Facial, Head, and NeckPain: Case Study with 7-year Follow-UpToni Jo Hanson, MD, [email protected],Rand L Redfern, DDS2, (1) Mayo Clinic, Rochester, MN,(2) Colorado Springs, COObjective: Diagnosis and management of patients withhead, facial, and neck pain is frequently a multidisci-

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plinary collaboration. A case study to increase awarenessof bisphosphonate related osteonecrosis of the jaw(BRONJ) as a potential pain generator and to demon-strate the role of advanced imaging and managementto improve outcomes is employed. Design andSetting: Case study in a clinical setting. Interven-tion: 58-year-old woman with a 2-year history of oralbisphosphonate (osteopenia) presented with head, neck,and facial pain. Pain with jaw movement and palpation ofthe masseter temporalis, TMJ, and nuchal musculaturewas noted. Cone Beam CT, MRI, and dental x-rays con-firmed diagnosis of stage 0 BRONJ. Treatment includeddiscontinuing the bisphosphonates, dental referral forsplint (to reduce TMJ loading, muscular activity), andphysical therapy. TMJ was debrided. Bone quality wassuboptimal for joint replacement. Main Outcome Mea-sures: Clinical outcome was excellent. Pain decreased90% (8–10/10 to 0–1/10). Serial CT revealed recortica-tion of the TMJ condyle and fossa. Cancellous bonesignal on MRI normalized. Results: A patient with head,jaw, and neck pain diagnosed with BRONJ markedlyimproved with diagnosis and intervention. Pain leveldecreased, functional outcome improved, and radiologicimaging normalized. She reported excellent outcome.Conclusions: Diagnosis and management of patientswith head, jaw, and neck pain treated with multidisci-plinary collaboration optimizes patient outcome inBRONJ. Splint use, physiotherapy, and discontinuationof bisphosphonates resulted in excellent patient outcome.References: 1) Drake, M.T.; Clark, B. L.; et al. (2008).“œBisphosphonates: mechanism of action and role inclinical practice.” Mayo Clin Proc 83(9):1032–1045. 2)Goncalves, D.A.; Camparis, C.M.; et al. (2011). “Tem-poromandibular disorders are differentially associatedwith headache diagnoses: a controlled study.” Clin J Pain27(7):611–615. 3) Hatcher, D.C.; Faulkner, M.G.. (1986).“Development of mechanical and mathematic models tostudy temporomandibular joint loading.” J Prosthet Dent55(3):377–384.Funding: None

205The Complex Regional Pain Syndrome SeverityScore (CSS): Evidence for Its Validity as anOutcome MeasureMaxine M Kuroda, PhD MPH, [email protected],Jaya Agnihotri2, Stephen Bruehl, PhD3,R Norman Harden, MD1, (1) Rehabilitation Instituteof Chicago, Chicago, IL, (2) University of Minnesota,Minneapolis, MN, (3) Vanderbilt University Schoolof Medicine, Nashville, TNIntroduction: The sensory, vasomotor, sudomotor, andmotor/trophic disturbances that characterize CRPS havebeen summarized into a clinically feasible severity score

(CSS) that may be useful in monitoring treatment. Toprovide evidence for validity of the CSS, this ongoingstudy determines the extent to which change in CSSis associated with changes in pain over time.Methods: Patients seen by pain medicine specialists andmeeting the 2011 IASP diagnostic criteria (Budapest) forCRPS are enrolled at 8 international centers under site-specific IRB approvals. Signs and symptoms include rel-evant features of CRPS that are scored for their presence(1) or absence (0), e.g., dystrophic changes to hair andnails, decreased ROM, and motor weakness comprise themotor/trophic features of CRPS. Total CSS is a 16-pointscore with 8 signs and 8 symptoms, and is evaluated at thebaseline and 3-month visits along with self-reportedratings of worst pain in the affected area. Results: For 125subjects with CRPS, total CSS scores (ranging from 0 to16) were associated with pain at the baseline and 3-monthvisits (r = .283, p = .003; r = .455, p < .001, respectively).Moreover, changes in CSS between the baseline and3-month visits were significantly associated with changesin pain between these visits in the expected direction (r =.243. p = .012). Conclusions: Changes in disease severity,as measured by the CSS, appear to parallel changes in painover time in CRPS patients. This supports the externalvalidity of the CSS as an outcome measure. References: 1)Harden RN, Bruehl S, Perez RSGM, Birklein F, MarinusJ, Maihofner C, Lubenow T, Buvanendran A, Mackey S,Graciosa J, Mogilevski M, Ramsden C, Chont M, VatineJ-J. Validation of proposed diagnostic criteria (the “Buda-pest Criteria”) for complex regional pain syndrome. Pain2010;150(2):268–74.Funding: None

206A New Opioid Risk Assessment Screening Tool:The Brief Risk Questionnaire (BRQ)Ted Jones, [email protected],Samantha Lookatch, MA2, Todd Moore, PhD2,(1) Behavioral Medicine Institute@ PCET, Knoxville, TN,(2) University of Tennessee, Knoxville, TNIntroduction: Opioid risk assessment has become a stan-dard of care when using opioids to treat chronic noncan-cer pain (CNCP), based on the guidelines produced bythe American Pain Society and the American Academy ofPain Medicine. To date, the research has found that com-monly used risk assessment tools (ORT, SOAPP,SOAPP-R, DIRE and PMQ) have not been as successfulas we would like, with accuracy rates in correctly identi-fying patients who later engage in medication aberrant-behavior often below 50%. Methods: The research wasapproved by the IRB of the University of TennesseeKnoxville. Patients being considered for opioid medica-tion at Pain Consultants of East Tennessee in Knoxville,

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TN, were assessed with a clinical interview, ORT andSOAPP-R. They were also administered a newly devel-oped risk assessment measure: the Brief Risk Question-naire (BRQ). This new measure has 12 items and is easilyunderstood by patients. A total of 331 patients wereassessed, with 186 being treated with opioids. Patientrecords were reviewed 6 months after the initial assess-ment for the presence of medication aberrant behavior.Results: Table 1 shows that the BRQ correctly predictedthe presence of medication aberrant behavior 78% of thetime, as compared to 30% for the SOAPP-R and 38% bythe ORT. Conclusions: The BRQ appears to be a validnew brief opioid risk assessment measure. References: 1)Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC,Davies P, Donovan MI, Fishbain DA, Foley KM, Fudin J,Gilson AM, Kelter A, Mauskop A, O’Connor PG, PassikSD, Pasternak GW, Portenoy RW, Rich BA, Roberts RG,Todd KH, Miaskowski C. American Pain Society-American Academy of Pain Medicine Opioids GuidelinesPanel. Clinical Guidelines for the Use of Chronic OpioidTherapy in Chronic Noncancer Pain. J Pain. 2009.10(2):113–130. 2) Webster LR, Webster RM. Predictingaberrant behaviors in opioid-treated patients: prelimi-nary validation of the Opioid Risk Tool. Pain Med. 2005.6(6):432–442. 3) Butler SF, Budman SH, Fernandez K,Jamison RN. Validation of a screener and opioid assess-ment measure for patients with chronic pain. Pain. 2004.112(1-2):65–75.Funding: Research grant from Ethos Laboratories

207The impairment of Vocabulary andArithmetic Ability in Complex Regional PainSyndrome PatientsJeeyoun Moon, [email protected], Yong-Chul Kim,Jang Hyun Kim, Jee Hyun Shin, (1) Seoul NationalUniversity Hospital, Seoul, KORComplex regional pain syndrome (CRPS) type I does nothave demonstrable nerve lesions, whereas CRPS type IIhas evidence of obvious nerve damage. CRPS can affectemotional distress and cognitive function. The aim of thisstudy was to find the different cognitive functionsbetween the control and CRPS type I patients groups.CRPS patients group consisted of 26 subjects, and thecontrol group consisted of 26 healthy subjects. They par-ticipated in the neurocognitive tests, which includedfour-subtests of the Korean version of the WechslerAdult Intelligent Scale-Revised (K-WAIS) and the TrailMaking Test (TMT)-A and TMT-B. CRPS patientsshowed the lower score in the Vocabulary subtest com-pared with control group (p = .005) (Figure 1). CRPSpatients showed low scores in the Arithmetic subtest (p =.026) compared with control group (p = .005). There

were no significant differences in Picture Arrangement,Block Design subtests and total IQ (Table 1). The per-formance on the TMT-A and TMT-B did not show sig-nificant differences between two groups (Figure 2). Wesuggest That CRPS affects the decline of Vocabulary andArithmetic intelligence, implying cognitive dysfunctionsof brain in CRPS patients.Funding: None

208Assessing Pain: The DeafCommunity’s ExperienceSandra Lefort, [email protected], Victor Maddalena, PhD2,Myles Murphy, (1) Memorial University of Newfoundland,St. John’s, NL, CAN, (2) Memorial University, St. John’s,Newfoundland, CANIntroduction: There is a dearth of research examiningdeaf people’s perceptions of pain and their ability to com-municate their pain to others. Two studies1,2 have inves-tigated the problem of pain in the deaf at end-of-life andpalliative care, and one study3 assessed four 1-dimensionalpain scales with deaf patients in a general hospital envi-ronment. These three studies identified similar problemsand concerns expressed by deaf patients in relation to painassessment and communication. The challenge is com-pounded by the need for interpreters who translateAmerican Sign Language (ASL) into English when thedeaf seek medical treatment. The purpose of this study isto examine deaf people’s perceptions of pain and its com-munication, the ASL interpreters’ experience with com-municating pain from the deaf person to healthcareproviders, and the best standardized pain assessment toolfor use with deaf people. Methods: Focus groups andindividual interviews with deaf people and ASL interpret-ers will be conducted using audio recordings to betterunderstand their perspectives in pain assessment withhealthcare providers. In addition, a new ‘faces-type’ painscale will be developed and tested that will attempt to bemore appropriate to the deaf population. This scale willbe compared to other commonly used 1-dimensional painscales. IREB approval by the provincial ethics board hasbeen obtained. Results: The results of the focus groupand individual interviews will be analyzed and presented.The development and evaluation of the new faces-typepain assessment tool will also be presented. Refer-ences: 1) Maddalena, V, O’Shea, F, Murphy, M. (2012).Palliative and end of life care in Newfoundland’s Deafcommunity. Journal of Palliative Care, 28(2), 105–12. 2)Allen B, Meyers N, Sullivan J, Sullivan M. (2002). Ameri-can sign language and end-of-life care: research in theDeaf community. HEC Forum, 14(3), 197–208. 3) PaleseA, Salvador L, Cozzi D. (2011). One-dimensional scalesfor pain evaluation adopted in Italian nursing practice:

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giving preference to Deaf patients. Journal of NursingMeasurement,19(2), 91–104.Funding: Canadian Institutes of Health Research - CIHR

209Functional Restoration in Active Duty ServiceMembers: Initial Outcomes in Psychologic MetricsJeffrey M Tiede, MD, [email protected],Mary Ellen Earwood, MD1, Karen Lehman, PsyD1,(1) Dwight D Eisenhower Army Medical Center, FortGordon, GAIt is important that service members are treated in amultidisciplinary setting with interprofessional assess-ment and treatment (Lew, 2009). Increasing levels dis-ability and prescription drug misuse are critical concernsto the DOD (Jeffrey, 2013). Civilian functional restora-tion programs have proven to be effective in difficultpatient populations (Gagnon, 2013). We started a pilotprogram, the Intensive Outpatient Program (IOP), atEisenhower Army Medical Center. Like civilian pro-grams, we focus on physical and behavioral interventions.However, unlike civilian programs, we emphasize a highlevel of physical training to ensure the service membercan return to military demands. Material/Methods: Thisis a retrospective analysis of PI data. Results will beupdated in an ongoing fashion. Service members arephysically active in rigorous exercises approximately15 hrs/week. Highlights include strict adherence to mili-tary structure and discipline, integration of army values,simulated soldier skills with occupational therapy, andincorporation of complementary and alternative medi-cine. Demographics: We present data from 103 servicemembers. Age varies from 19 to 55, rank varies from E-3(private first class) to O-5 (Lieutenant Colonel). Etiologyof pain varies with lumbar spondylosis, cervical spondy-losis and myofascial pain syndrome being common.Results: Here we present generalized outcomes for psy-chologic metrics. PHQ-9 decreased from 9.2 (milddepression) to 4 (none). GAD-7 decreased from 12.9(moderate anxiety) to 3.65 (none). Improvements werealso seen in PCS and SOPA measurements. Refer-ences: 1) Gagnon, C. (2013). Treatment Outcomes forWorkers Compensation Patients in a US-Based Interdi-ciplinary Pain Management Program. Pain Practice,282–288. 2) Jeffrey, D. (2013). Prescription Drug MisuseAmong U.S. Active Duty Military Personnel: a Second-ary Analysis of the 2008 DoD Survey of Health RelatedBehaviors. Military Medicine, 180–195. 3) Lew, H.(2009). Prevalence of chronic pain, posttraumatic stressdisorder, and persistent postconcussive symptoms inOIF/OEF veterans: Polytrauma clinical triad. Journal ofRehabilitation Research and Development, 697–702.Funding: None

210Treatment Outcomes of Post-stroke Pain in aChronic Pain Rehabilitation ProgramManu Mathews, MD, [email protected],Judith Scheman, PhD2, Sara A Davin, PsyD MPH3,Danette Conklin, (1) Cleveland Clinic Foundation,Cleveland, OH, (2) Cleveland Clinic, Cleveland, OH,(3) Cleveland Clinic Neurological Institute, Cleveland, OHPain following a stroke is a well-known phenomenon.There are very few treatment modalities that have beenshown to improve the pain, function and affectivechanges in these patients. We evaluated the outcomes ofpatients with post stroke pain who completed treatmentin an Interdisciplinary Pain Rehabilitation Program.Methods: The study was a retrospective review of 10patients. The changes in pain, depression, anxiety, andfunction were assessed. Results: There was a statisticallysignificant improvement in the pain, depression, and dis-ability in these patients following treatment. Theimprovements were in the region of 40%–50% in painand disability, and the depression improved from severeto mild. Conclusion: Interdisciplinary pain rehabilitationis an effective treatment modality for patients with post-stroke pain. This is particularly important given thelimited treatment options for this condition and the clearimprovement in not just pain, but also in disability anddepression. References: 1) Appelrose P. Prevalance andpredictors of pain and fatigue after stroke: A populationbased study. International Journal of RehabilitationResearch 2006;29:329–333. 2) Jonsson AC, Lindgren I,Hallstrom B, et al. Prevalence and intensity of pain afterstroke: A population based study focusing on patients’perspective. Journal of Neurology, Neurosurgery, andPsychiatry 2011;77:590–595,3) Lundstrom E, Smits A,Terent A, Borg J. Risk factors for stroke-related pain1year after first-ever stroke. European Journal of Neurol-ogy 2009;16:188–193.Funding: None

211Evaluating the Effectiveness of MindfulnessMeditation for Chronic Musculoskeletal Pain inU.S. Veterans Using the Defense and VeteransPain Rating Scale (DVPRS)Thomas Nassif, PhD MS, [email protected],2,Deborah O Norris, PhD2,3, Karen Soltes, LCSW, MA Ed,RYT1, Marc R Blackman, MD3, Julie C. Chapman, PsyD1,Friedhelm Sandbrink, MD3, (1) War Related Illness andInjury Study Center, Washington, DC, 2) AmericanUniversity, Washington, DC, (3) Veterans Affairs MedicalCenter, Washington, DCThe DVPRS is a standardized tool for measuring pain inmilitary and veteran settings. Limited information existsregarding the validity of the DVPRS. To our knowledge,

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this study represents the first use of the DVPRS in aresearch setting and comparison with the Brief PainInventory (BPI) and Visual Analog Scale (VAS). TheDVPRS and BPI measure pain intensity and interference.The DVPRS pain intensity scale includes visual cues andverbal descriptors to improve interpretability of incre-mental pain intensity levels. DVPRS supplemental ques-tions assess pain interference with general activity, sleep,mood and stress. This IRB-approved pilot study at theWar Related Illness and Injury Study Center examinedthe effectiveness of iRest® meditation for managingchronic musculoskeletal pain in veterans with traumaticbrain injury. Participants were randomly assigned toreceive iRest (n = 4) or routine treatment (n = 5) for 8weeks. Measures were obtained at baseline (B), endpoint(E) and 4-week follow-up (F). iRest practice led to “mod-erately important” reductions in pain interference(>30%), according to IMMPACT guidelines, which wereconsistently significant for both DVPRS and BPI fromB-E (41.1%, p = .013; 32.7%, p = .047) and B-F (34.2%,p = .032; 33.7%, p = .012). Pain intensity decreased in the“minimal” to “moderate” range for B-E and B-F acrossall measures with only the VAS reaching statistical sig-nificance for B-F (p = .04). The control group showed noimprovements in pain interference or intensity. Thesedata suggest the DVPRS was reliable in assessing pain ina small veteran cohort, and iRest elicited greater benefi-cial effects on pain interference than intensity. Refer-ences: 1) Buckenmaier, C. C., Galloway, K. T.,Polomano, R. C., McDuffie, M., Kwon, N., & Gallagher,R. M. (2013). Preliminary validation of the defense andveterans pain rating scale (DVPRS) in a military popula-tion. Pain Medicine,14(1), 110–123. 2) Dworkin, R. H.,Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C.S., Farrar, J. T., et al. (2008). Interpreting the clinicalimportance of treatment outcomes in chronic pain clini-cal trials: IMMPACT recommendations. The Journal ofPain, 9(2), 105–121.Funding: 1) War Related Illness and Injury Study Center atthe Washington, D.C. Veterans Affairs Medical Center;2) American University, Washington, DC

212Follow-Up Evaluation of a 4-Week MultidisciplinaryPain ProgramJosie Tyrer, [email protected], Juliette Galindo, MA1,Leanne R Cianfrini, PhD1,2, (1) University of Alabama atBirmingham, Birmingham, AL, (2) The Doleys Clinic,Birmingham, ALIntroduction: Although physical and emotional benefitsof multidisciplinary pain treatment (MDT) programs arewell documented, long-term effects of such programs arerarely reported. The present study queried patientsbetween 18 months to 7 years post-completion of an

MDT program. Materials/Methods: IRB-approvedphone interviews were conducted on 22 patients at least18 months after completion of a 4-week residential MDTprogram. Ratings of pain intensity and interference werecollected within physical, emotional, environmentaldomains. We inquired about use (type, frequency) ofcoping strategies taught in the program. Changes inquality of life (QoL), pain, mood, and medication usesince participation will be presented in table format,along with descriptive data. Qualitative feedback will beprovided in graphic format. Results: The averagenumber of coping techniques used was 2.82, with relax-ation techniques most prevalent. Most responders indi-cated improvements in pain (59.1%), mood (63.6%),QoL (68.2%), and reduced medication use since programcompletion. Although pain severity and interference werestrongly correlated, those who reported pain improve-ment were significantly more likely to endorse improvedmood and QoL. Qualitative feedback was more positivethan negative and emphasized staff interpersonalexperiences and instruction quality. Negative feedbackpertained to environmental factors (e.g., food, accommo-dations), personal limitations or readiness for change, andinterpersonal experiences. Conclusions: Patients contin-ued to use multiple skills acquired in MDT, up to 7 yearsafter completion, especially relaxation techniques. Find-ings lend support to the long-term efficacy of MDTprograms for improvements in pain, mood, reducedmedication use, and QoL, independent of perceived painintensity. References: 1) Keogh, E., McCracken, L.M.,Eccleston, C. (2005). Do men and women differ in theirresponse to interdisciplinary chronic pain management?Pain, 114, 37–46. Doi: 10.1016/j.pain.2004.12.009. 2)Spinhoven, P., Kuileb, M., Kole-Snijgers, Mansfelda,M.H., Oudena, D., Vlaeyend, J.W.S. (2004). Catastroph-izing and internal pain control as mediators of outcomein the multidisciplinary treatment of chronic low backpain. European Journal of Pain, 8, 211–219.Funding: None

213Interdisciplinary Pain Rehabilitation forFibromyalgia: Evidence of Long-Term BenefitsBrinder Vij, MD, [email protected], Kelly L Huffman, PhD1,Sara A Davin, PsyD MPH2, Judith Scheman, PhD2,(1) Cleveland Clinic, Cleveland, OH, (2) Cleveland ClinicNeurological Institute, Cleveland, OHA substantial literature supports the benefits of a multi-disciplinary treatment approach in fibromyalgia (FM).Most research utilizes a combination of two or threeindependently provided treatment modalities.1 Limitedstudies have examined the benefits of a coordinated,intensive interdisciplinary rehabilitation program (IPR)

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for FM,2 and few studies have assessed the long termsustainability of treatment benefits.3,4 This study was aretrospective analysis of clinical outcomes data tracked inan IRB approved registry. This study investigated theimmediate and long-term (12 month) treatment out-comes for 366 patients with FM completing a 3–4 weekIPR. Follow-up data were available for 100 participants(32.68% of program completers). Two tailed matchedpair t-tests were used to compare pain severity, depres-sion, anxiety, and pain related functional impairment atadmission, discharge, and 12 months post treatment.Results demonstrated statistically and clinically signifi-cant improvements at discharge, including decreases inpain (p < .01), normalization of depression (p < .01),normalization of anxiety (p < .01) and decreases in func-tional impairment (p < .01). While 12-month datashowed slight increases in pain severity, depression,anxiety, and pain-related functional impairment (com-pared to admission levels), improvements in pain severity,depression, anxiety, and pain related functional impair-ment continued to be statistically and clinically signifi-cant. Results provide compelling support for the long-term benefits of treating FM within an IPR. Futureresearch is needed to identify those patients with FM whomay benefit from additional relapse prevention interven-tions, after participation in an IPR. References: 1) Sarzi-Puttini P, Atzeni F, Salaffi F, Cazzola M, Benucci M,Mease PJ. Multidisciplinary approach to fibromyalgia:What is the teaching? Best Pract. Res. Clin. Rheumatol.2011; 25: 311–319. 2) Martin J, Torre F, Padierna A,Aguirre U, Gonzalez N, Garcia S, Matellanes B, Quin-tana JM (2012). Six and 12 month follow-up of an inter-disciplinary fibromyalgia treatment programme: resultsof a randomized trial. Clin Exp Rheumatol. 2012;30(Suppl. 74): S103-S111. 3) Angst F, Brioschi R, MainCJ, Lehmann S, Aeschlimann A. Interdisciplinary reha-bilitation in fibromyalgia and chronic back pain: A pro-spective outcome study. J. Pain. 2006; 7(11): 807–815.Funding: None

Translational

214Low Level Steady Heat Compared to High-LevelPulsed Heat for the Treatment of PremenstrualSyndrome (PMS) PainCharles Chabal, MD, [email protected],Peter J Dunbar, MD2, Susan A Stoner, PhD3,(1) Evergreen Hospital & Medical Center, Kirkland, WA,(2) University of Washington, (3) Talaria Inc., Seattle, WAIntroduction: Primary dysmenorrhea (PMS) affectsmore than 50 percent of all women who have a menstrualperiod, and 5% to 15% have pain that interferes withdaily activities.1 Recent studies demonstrate that low-

level heat can significantly reduce PMS pain.2,3 Thisstudy compared the effectiveness of low-level heat versuspulsed high-level heat in the treatment of PMS. Materialsand Methods: The study was approved by the WesternInstitutional Review Board. 17 subjects with PMS wererecruited from online postings. Subjects underwent arandomized crossover trial with 30 minutes of treatmentusing a commercially available chemical (ThermaCare®)hot pack (39–40°C) and 30 minutes of high level pulsedheat (44–47°C) from the study device. There was a45-minute washout between treatment sessions. Painlevels were measured using several standardized scales atbaseline and after 10, 20 and 30 minutes of treatment.Results: Results of paired-sample t-tests indicated sig-nificantly greater decrease in Iowa Pain Thermometerscores from baseline to 30 minutes with high-level heat (p< .001) from baseline to 10 minutes (p = .005), and fromthe 20 to 30 minutes (p = .009). Similar results were notedwith assessments done with the Numeric RatingScale. Subjects showed significant preference for thepulsed high-level heat as compared to the lower steadyheat provided by the chemical heat packs. Conclu-sions: High-level pulsed heat produced significantlyfaster and more profound pain relief as compared tolow-level steady heat. The results may suggest methodsto improve nonpharmacological treatment options forPMS. References: 1) Penn State Milton S. HersheyMedical Center College of Medicine, Dysmenorrhea:Who gets it http://www.hmc.psu.edu/healthinfo/d/dysmenorrhea.htm (accessed September 17, 2004). 2)Akin MD, Weingand KW, Hengehold DA, Goodale MB,Hinkle RT, Smith RP. Continuous low-level topical heatin the treatment of dysmenorrhea. Obstetrics and Gyne-cology 2001; 97(3): 343–49. 3) Akin M, Price W, Rodri-guez Jr. G, Erasala G, Hurley G, Smith RP. Continuous,low-level, topical heat wrap therapy as compared to acet-aminophen for primary dysmenorrhea. The Journal ofreproductive medicine 2004; 49(9): 739–45.Funding: This work was supported by grants R43CA099305-01A2 and R44 CA099305-02 from the NationalCancer Institute awarded to Talaria Inc.

215Low-Level steady Heat Compared to High-LevelPulsed Heat for the Treatment of Low BackPain (LBP)Charles Chabal, MD, [email protected],Peter J Dunbar, MD, Susan A Stoner, PhD2, (1) EvergreenHospital & Medical Center, Kirkland, WA, (2) Talaria,Inc., Seattle, WAIntroduction: One third of all Americans suffer fromback pain at some point during the year. Men and womenare equally affected. Nearly everyone at some point has

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back pain that interferes with work, daily activities, orrecreation. Heat has long been a mainstay treatment oflow back pain. A number of well-designed studies showthat heat reduces pain and improves function in sufferersof low back pain. This study compared low-level steadyheat to pulsed high temperature heat in subjectswith chronic low back pain (LBP). Materials andMethods: The study was approved by the Western Insti-tutional Review Board. 27 subjects with LBP wererecruited from online postings. Subjects underwent arandomized crossover trial with 30 minutes of treatmentusing a commercially available chemical (ThermaCare®)hot pack (39–40 C) and 30 minutes of high level pulsedheat (44–47 C) from the study device. There was a45-minute washout between treatment sessions. Painlevels were measured using several standardized scales atbaseline and after 10, 20 and 30 minutes of treatment.Results: Results of paired-sample t-tests indicated sig-nificantly greater decrease in Iowa Pain Thermometerscores from baseline to 30 minutes with high–level heat (p< .003) and from baseline to 10 minutes (p = .04). Similarresults were noted with assessments done with theNumeric Rating Scale. Conclusions: High-level pulsedheat produced significantly faster and more profoundpain relief as compared to low-level steady heat. Theresults were similar to those found in an earlier study insubjects with PMS.Funding: This work was supported by grants R43CA099305-01A2 and R44 CA099305-02 from the NationalCancer Institute awarded to Talaria Inc.

216Intervertebral Disc Stem Cell Transplant isAssociated with Increases Disc Height—A Meta-Analysis of Animal Randomized,Controlled TrialsJason Dauffenbach, DO, [email protected],Zhen Wang, PhD1, Matthew J Pingree, MD1,William D Mauck, MD1, Yuexiang Wang1, Wenchun Qu,MD PhD1, (1) Mayo Clinic, Rochester, MNIntroduction: Intervertebral disc (IVD) degenerativedisease is ear-marked with poor self-repair capacity sec-ondary to the loss of IVD cells. With recent developmentof stem cell research, it has become possible to assess thefunctionality of transplanted stem cells in vivo. This sys-tematic review focuses on the disc height changes inanimal randomized, controlled trials after stem cell trans-plant into degenerative IVD. Methods: Relevant studiespublished from database inception to September 1, 2013,were identified through database searches of MEDLINE,EMBASE, PsycINFO, and manual searching of refer-ence lists. Only original randomized controlled trials onanimals that examined the association between interver-

tebral disc stem cell transplant and the change of discheight index were included. Six studies met inclusioncriteria. Because of the heterogeneity of these studies,random-effects models were used to pool estimates ofeffect. Results: Overall, intervertebral disc stem celltransplant was associated with 23.6% increase in discheight index (95% confidence interval [CI], 19.7–23.5; p< 0.001). Of all the six studies, none showed decrease ofdisc height index in the transplant group compared withthe controlled group. The increase of disc height indexwas statistically significant in all individual studies. Dis-cussion: Histologic studies showed that the transplantedstem cells were viable. The increase of the disc height wasattributed to restoration of the nucleus pulposus struc-ture and the increased amount of aggrecan in the trans-plant group. Conclusion: Findings of this meta-analysisindicates that cell therapy may arrest or reverse the IVDdegenerative process. References: 1) Liang CZ, Li H,Tao YQ, Peng LH, Gao JQ, Wu JJ, Li FC, Hua JM,Chen QX. Dual release of dexamethasone and transform-ing growth factor from polymeric microspheres for thestem cell matrix accumulation in a rat disc degenerationmodel. Acta Biomater. 2013 Aug 22. [Epub ahead ofprint]. 2) Feng G, Zhao X, Liu H, Zhang H, Chen X, ShiR, Liu X, Zhao X, Zhang W, Wang B. Transplantation ofmesenchymal stem cells and nucleus pulposus cells in adegenerative disc model in rabbits: a comparison of 2 celltypes as potential candidates for disc regeneration. J Neu-rosurg Spine. 2011 Mar;14(3):322–9.Funding: None

217Assessment of the Antinociceptive Effects ofSalmon Thrombin in Preclinical Models ofPost-Operative PainDenise Giuvelis, [email protected], James Cormier, BS1,Beth Winkelstein, PhD2, Evelyn Sawyer, PhD3,Edward Bilsky, PhD3, (1) University of New England,Biddeford, ME, (2) University of Pennsylvania,Philadelphia, PA, (3) Sea Run HoldingsSalmon thrombin (ST), an effective hemostatic agent,exhibits unique analgesic, neuroprotective, and anti-inflammatory properties in preclinical models ofneuropathic injury. We continue to investigate ST phar-macology and assess its effects in other pain models.Local application of ST was assessed for its efficacy fol-lowing two models of post-operative pain: a plantar inci-sion surgery and a novel calcaneus bone pain model ofpain. Rats undergoing plantar incision surgery developedthermal hyperalgesia and tactile allodynia 12–48 hrspost-surgery. ST administered into the wound at time ofsurgery significantly reduced development of thermalhyperalgesia and inflammation but not tactile allodynia at

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doses of 1,000, 3,200 and 5,600 U/ml (doses which pro-duced no observable adverse effects). In the bone painmodel, rats underwent plantar incision surgery followedby drilling a 1-mm diameter hole through the calcaneusbone. ST or vehicle was administered at a volume of50 ml directly into the hole and incision. ST was effectiveat reducing the number of spontaneous flexions/elevations of the injured paw at doses of 100 and1,000 U/ml and reduced the development of thermalhyperalgesia at 1,000 U/ml. ST had no effect on devel-opment of tactile allodynia or restoration of baselineweight bearing measurements. This work helps supportthe claim that ST is a promising early intervention forreducing post-operative pain and inflammation. Thiswork was supported by a contract from Sea Run Hold-ings, Inc. to the University of New England.Funding: Funding was provided as a contract from Sea RunHoldings to the University of New England

219Stanford-NIH Pain Registry: Catalyzing theRate-Limiting Step of Big Data Psychometrics withItem-Response Theory and AdvancedComputerized Adaptive TestingMing-Chih Kao, MD, [email protected],Karon Cook, PhD2, Garrick Olson, BS3, Teresa Pacht, BS3,Beth Darnall, PhD4, Susan Weber, PhD4, Sean Mackey,MD PhD4, (1) Stanford University, Cupertino, CA,(2) Northwestern University, Houston, TX, (3) StanfordSchool of Medicine, Palo Alto, CA, (4) Stanford Hospitalsand Clinics, Palo Alto, CAIntroduction: Unlike passive biometric measurements,psychometric measures require active participation fromsubjects and are rate-limited by subject burden. NIHPROMIS and Toolbox provide efficient questionnairesbased on item-response theory (IRT) and computerizedadaptive testing (CAT). Leveraging these item banks anddeveloping advanced CAT algorithms can reduce burdenand enable big data psychometrics. Methods: The algo-rithm SNAPL-CAT is developed on open source MEANstack with D3.js visualization. Item banks and linkages areobtained from Northwestern Access Center and PRO-setta Stone. Features include initialization (individualizedor patient population priors), item selection (expectedKullback-Leibler, minimum expected posterior variance),advanced item selection (alpha-stratification, exposurecontrol, content balancing, probabilistic constrainedoptimization), stopping rule (predicted standard errorreduction, percentile width, hybrid), and estimation(expected a posteriori, maximum likelihood, maximum aposterior). Performance in 4,466 measurements in theregistry are analyzed. Results: Basic CAT provided sig-nificant reduction in burden (mean number of items ±

SD, fold reduction): Anger (6.24+/−1.21, 4.6-fold vsBPAQ), Anxiety (4.93+/−0.97, 1.4-fold vs GAD-7),Depression (4.97+/−1.07, 1.8-fold vs PHQ-9), Fatigue(4.78+/−0.76, 8.4-fold vs FACIT-F), Physical Function(4.11+/−0.48, 4.9-fold vs HAQ-DI), Pain Interference(4.19+/−0.71, 1.7-fold vs BPI), Sleep Disturbance (4.95+/−1.41, 2.4-fold vs SDQ), Sleep-Related Impairment(4.54+/−1.24, 1.8-fold vs ESS). Altogether, the 132 classicinstrument items may be alternatively assessed by 38.7+/− 7.9 items, for 2.8 to 4.3 fold reduction in patientburden. Conclusions: Using IRT and advanced CAT, theStanford-NIH Pain Registry and SNAPL-CAT leveragethe powers of NIH PROMIS and Toolbox, and enablebig data psychometrics for the study of pain.Funding: NIH HHSN 271201200728P and Redlich PainEndowment

220Stanford-NIH Pain Registry: Open Source Platformfor Large-Scale Longitudinal Assessment ofClinical Data and Patient-Reported OutcomesMing-Chih Kao, MD, [email protected],Karon Cook, PhD2, Garrick Olson, BS3, Teresa Pacht, BS3,Beth Darnall, PhD4, Susan Weber, PhD4, Sean Mackey,MD PhD4, (1) Stanford University, Cupertino, CA,(2) Northwestern University, Houston TX, (3) StanfordSchool of Medicine, Palo Alto, CA, (4) Stanford Hospitalsand Clinics, Palo Alto, CAIntroduction: The Institute of Medicine (IOM) inRelieving Pain in America report (2011) called for thedevelopment of national patient registries to support thedevelopment of learning healthcare systems. In particularfor the management of patients with chronic pain, theIOM has called for national patient outcome registriesthat can support point-of-care decision making andlarge-scale assessment of safety and effectiveness oftherapies. Methods: Web-based applications are devel-oped to assess patients and to support clinic staff withintegrating the pain registry into the clinic workflow.Patient assessment features are designed for use onmobile devices with touch interfaces (smart phones andtablets), while also supporting desktop web browsers. Keytechnologies used include Java, Oracle database, GoogleWeb Toolkit, and jQuery Mobile. Results: Since roll-outin August 2012 and the subsequent slow ramp-up, over2,200 unique patients have completed surveys, with over4,500 assessments overall. Surveys were completed athome via email link, or at the Pain Clinic, using comput-ers, iPads, Android tablets, and Chrome notebooks. Con-clusions: An open source, extensible platform wascreated that enables rapid definition and deployment ofdata capture tools. This represents a successful partner-ship between the NIH and Stanford with funding from

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most of the NIH Institute Directors. Future worksinclude the expansion of survey items, into additionaldisease areas, dissemination of code, as well as networkedregistry build-out.Funding: NIH HHSN 271201200728P and Redlich PainEndowment

221Conditioned Pain Modulation Decreases DorsalHorn BOLD Signal in the Human Spinal CordIan Mackey, [email protected], Paul Nash, PhD1,Brittney Reyes1, (1) Stanford University, Palo Alto, CAIntroduction/Statement of the Problem: Chronic painresearch has recently focused on the brain’s role inendogenous pain control, which is diminished in patientswith chronic pain. Conditioned pain modulation (CPM)has been used to test endogenous analgesia in this setting.Mechanistically, CPM involves spinal neuron inhibitionby nociceptive stimulation applied outside their own seg-mental receptive fields. While human studies have showneffects behaviorally and in the brain, the spinal basis firstdescribed in rats has yet to be shown in humans. There-fore, our aim was to characterize the effects of CPM inthe human spinal dorsal horn. We hypothesized thatCPM would reduce spinal fMRI activity. Materials andMethods: We used a standard CPM task (test stimulus −test + CPM) using two separate spiral fMRI scans to actas (1) the test stimulus (heat pain applied to the left volarforearm, block design scan) and (2) the test stimulus +CPM (Identical heat pain scan collected while the sub-ject’s contralateral foot was immersed in a cold water bath(12O C)). Institutional IRB approval was obtained.Results: fMRI images were corrected for physiologicnoise, preprocessed and had individual and group statis-tics performed. The test stimulus analysis revealed sig-nificant activity within the ipsilateral dorsal horn.Comparison between the test stimulus alone and the teststimulus + CPM task revealed a significant decrease infMRI activity during CPM. Conclusions: This studyconfirmed our hypothesis and is the first study to char-acterize the significant effects of CPM on human spinaldorsal horn activity. References: 1) Nash P, Wiley K,Brown J, Shinaman R, Ludlow D, Sawyer AM, Glover G,Mackey S, Functional Magnetic Resonance ImagingIdentifies Somatotopic Organization of Nociception inthe Human Spinal Cord, Pain 2013, 154:776–81. 2) KongJT, Schnyer RN, Johnson KA, Mackey S, Understandingcentral mechanisms of acupuncture analgesia usingdynamic quantitative sensory testing: a review, EvidBased Complement Alternat Med, 2013, 187182.Funding: R01 NS053961, Redlich Pain Endowment

222Influence of Traumatic Brain Injury (TBI),Posttraumatic Stress Disorder (PTSD), and BlastExposure on Pain Levels in OEF/OIF/OND VeteransMilan Stojanovic, [email protected],Catherine Fortier, PhD1, Jennifer R Fonda, MA1,James L Rudolph, MD SM1, William Milberg, MD2,Regina McGlinchey, PhD2, (1) VA Boston HealthcareSystem, Boston, MA, Weston, MA, (2) New EnglandGRECC, VA Boston Healthcare, Boston, MAIntroduction/Statement of the Problem: Traumaticbrain injury (TBI), posttraumatic stress disorder (PTSD)and blast exposure are common among US veteransof Operation Enduring Freedom/Operation IraqiFreedom/Operation New Dawn (OEF/OIF/OND). Wepostulated that these injuries may modulate pain process-ing in these individuals and affect their subjective painlevels. Materials and Methods: 284 deployed servicemembers of OEF/OIF/OND were enrolled in the studyapproved by IRB. Participants were recruited at veterans’events and via flyers posted at the VA Medical Center.Study was conducted at Translational Research Centerfor TBI and Stress Disorders (TRACTS) Center ofExcellence. All participants completed a comprehensiveevaluation for blast exposure, TBI, PTSD, and PainLevels. The Boston Assessment of TBI-Lifetime Version(BAT-L) was used to assess blast exposure and potentialbrain injury during a service member’s lifetime. Thepresence and severity of PTSD was assessed using theClinician-Administered PTSD Scale (CAPS). McGillPain Questionnaire was utilized to assess pain levels overthe last month before the interview, with higher scoresindicative of worse pain. Statistical analysis was per-formed by ANOVA. Results: In comparison to controls(subjects without military TBI and current PTSD), sub-jects who had combination of PTSD and TBI experi-enced significant pain levels (39.5 vs. 19.0; p < 0.05)followed by PTSD only subjects (32.2 vs. 19.0; p < 0.05).Blast exposure alone was also associated with increasedpain levels (30.2 vs. 23.0; p = 0.0405). Conclu-sions: PTSD, TBI, and blast exposure are associatedwith increased levels of self-reported pain. References: 1)Dobscha SK, Clark ME, Morasco BJ, Freeman M,Campbell R, Helfand M. Systematic review of the litera-ture on pain in patients with polytrauma including trau-matic brain injury. Pain Med. 2009;10(7):1200–17. 2)Fortier CB, Amick MM, Grande L, McGlynn S, KennaA, Morra L, Clark A, Milberg WP, McGlinchey RE. TheBoston Assessment of Traumatic Brain Injury-Lifetime(BAT-L) Semistructured Interview: Evidence of ResearchUtility and Validity. J Head Trauma Rehabil. 2013; 26. 3)Taylor BC, Hagel EM, Carlson KF, Cifu DX, Cutting A,Bidelspach DE, Sayer NA. Prevalence and costs of

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co-occurring traumatic brain injury with and withoutpsychiatric disturbance and pain among Afghanistan andIraq War Veteran V.A. users. Med Care 2012;50(4):342–6.Funding: This research was supported by the TranslationalResearch Center for TBI and Stress Disorders (TRACTS), aVA Rehabilitation Research and Development TraumaticBrain Injury Center of Excellence (B6796-C), NIH NIAK23AG034258, and VA Merit Review Award to ReginaMcGlinchey.

223Unbiased Screens for Novel Signaling Regulatorsof the Mu Opioid ReceptorJohn Streicher, [email protected], Emmanuel Moses-Fynn,MD2, Justin Lavigne, BS1, (1) University of New England,Biddeford, ME, (2) University of Maine, Orono, MEChronic pain is a serious health concern with high costsand a significant impact on patient quality of life. A multi-decade drug discovery effort targeted at finding new paintherapeutics has met with limited success. Recent workhas demonstrated that specific signaling cascades (i.e.βarrestin2) downstream of the mu opioid receptor (MOR)mediate specific behavioral effects, and that functionallyselective drugs that specifically activate the desired cas-cades can have an enhanced therapeutic index. However,very few regulatory proteins that can be targeted in thismanner have been described. In order to facilitate theidentification of such targets, we have applied twomethods of unbiased screening to find novel signalingregulators of the MOR. For one, we have created a MOR-CHO cell line, and used co-immunoprecipitation ofdrug-activated receptor complexes followed by proteomicanalysis to find novel associated proteins. For the other,we have created a MOR-HEK cell line with a live cellfluorescent reporter of signal transduction, along with apooled shRNA library to identify genes which regulateMOR induced signaling. From these data, we will identifya list of potential signaling regulators of the MOR and willfurther test the effect of candidate knockdown on MORinduced signaling. Using this approach, we have initialconfirmation that a novel scaffold protein previouslyunassociated with the MOR regulates MOR inducedERK activation. Overall, we hope to use this data tofurther define the MOR signaling complex, and to iden-tify new targets and strategies for drug discovery to treatchronic pain.Funding: UNE COBRE Pilot Project Grant

224Does Pain Treatment Always ReduceInflammation?Forest Tennant, MD, [email protected], (1) Veract Inc.,West Covina, CAIntroduction/Statement of the Problem: Chronic painand inflammation are inextricably related. Inflammationcauses tissue destruction, so appropriate pain treatmentrequires the elimination of inflammation. Materials andMethods: Thirty-one (31) patients who entered intrac-table pain treatment and who demonstrated an elevatederythrocyte sedimentation rate (ESR) and/or C-reactiveprotein (CRP) were retested 3 to 4 months following atreatment regimen that consist of opioids, plus a varietyof antidepressants, anti-inflammatories, and neuropathicagents. At the time of retesting, patients were consideredstabilized with reasonable pain control in that they couldcarry out activities of daily living and had normal bloodpressure and pulse rate. Results: Twenty-seven (27)patients demonstrated a high CRP on admission, and 15(55.5%) were normal on retesting. Fourteen (14) patientshad an elevated ESR on admission, and only 4 (28.6%)had returned to normal on retesting. The majority ofelevated ESR patients (10; 71.4%) and a significant per-centage of elevated CRP (12; 44.4%) patients remainedelevated at retesting. Conclusions: The continued eleva-tion of inflammatory markers in a significant percentageof patients during standard treatment for intractable painindicates that strategies are needed to reduce inflamma-tion in some patients. Although, it is unclear whetherthese elevated inflammatory markers come from periph-eral, central, or combined sources, it is clear that inflam-mation should be assessed and monitored.Funding: None

225Effect of Pregabalin on the ED50 of IntravenousAlfentanil in Capsaicin-Induced PainMark S Wallace, MD, [email protected], (1) ThortonHospital, UCSD, La Jolla, CAThe purpose of this study was to investigate the syner-gistic actions of an N-type calcium channel antagonistand an opioid on intradermal capsaicin-induced pain.Using the sequential up-down method, the ED50 ofintravenous alfentanil was determined under two condi-tions: alfentanil alone (PHASE I) and alfentanil + prega-balin (300 mg po) (PHASE II). Using a double-blind,randomized, crossover design, the alfentanil plasma level(using a computer controlled infusion) producing asuccess criterion was used to determine higher or lowerdoses of each sequential subject. The success criterion inall subject groups was a 30% reduction in the area underthe pain score versus time curve after capsaicin injectionof active drug compared to placebo. The median dose

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producing a success criterion and its confidence intervalwas determined. A total of 19 subjects were required inphase I and 12 subjects in phase II. Although the ED50 ofalfentanil was lower in the presence of pregabalin(58.42 ng/ml vs 51.95 ng/ml), it was not significant(p-value: 0.334). Of the subjects who completed thestudy, 6 subjects in phase I and 11 subjects in phase IIreported side effects. Although pregabalin reduced theED50 of alfentanil, it did not reach statistical signifi-cance. In addition, there were no significant differencesin pain scores versus alfentantil plasma level between thetwo phases. Unlike our previous study with pregabalinalone, pregabalin added to alfentanil in this studyappeared to increase reported side effects which couldhave been a confounding factor. References: 1) Wong W,Wallace MS. Determination of the Effective Dose ofPregabalin on Human Experimental Pain Using theSequential Up-Down Method. Pain Medicine, 2013, InPress.2) Concentration effect relationship for intrave-nous alfentanil and ketamine infusion in human volun-teers: Effect upon acute thresholds and capsaicin-evokedhyperpathia. J Clin Pharmacol, 2002, 42:70–80. 3) DixonW. Staircase bioassay: the up-and-down method. Neuro-sci Biobehav Rev 1991;15:47–50.Funding: Pfizer Investigator Initiated Research Award

226Expression of NOD-Like Receptor C4 in the SpinalCord and Dorsal Root Ganglion (DRG) in Rats andIts Up-Regulation in Relation to Neuropathic PainJianguo Cheng, MD PhD, [email protected], Lina Wang,MD2, Jun Shen, MD2, Aijun Liu, MD PhD2,Yingchun Han, MD2, (1) Cleveland Clinic Foundation,Cleveland, OH, (2) Cleveland Clinic, Cleveland, OHChemokines and their receptors, such as glial toll-likereceptor 4 (TLR4), play a significant role in the patho-physiology of chronic pain.1 Inflammasome, a molecularscaffold complex, is critical for TLR signaling and isresponsible for the activation of inflammatory processes.The Nod-like receptors (NLRs)-containing inflamma-somes NLRP1, NLRP3, and NLRC4, are crucial forTLR activation.2 A functional Naip5-NLRC4 inflamma-some has recently been shown in microglia of the centralnervous system.3 Since neuroinflammation is a criticalmechanism of neuropathic pain, we hypothesized thatNLRC4 is expressed in microglial cells in the spinal cordand is associated with the development of neuropathicpain after sciatic nerve injury. Using double immunofluo-rescence staining technique, we demonstrated expressionof NLRC4 in microglial cells in the rat spinal cord.Unexpectedly, we also found NLRC4 expression inneurons and astrocytes in the spinal cord as well asneurons in the DRG. The expression of NLRC4 in thesecells was significantly increased in after chronic constric-

tion injury of the sciatic nerve. The increase in varioustime points after the nerve injury was consistent with thetime course of development of hyperalgesia and allo-dynia, as determined by the thresholds of withdrawalresponses to mechanical and thermal stimuli. There weredifferential patterns of NLRC4 expression in these typesof cells over time. These results suggest that NLRC4may play an important role in neuroinflammation andcontribute to the pathophysiology of neuropathic pain.NLRC4 may specifically be involved in the developmentand maintenance of neuropathic pain consequent tonerve injuries. References: 1) White FA, Wilson NM.Chemokines as pain mediators and modulators. CurrOpin Anaesthesiol. 2008;21(5):580–5. 2) Franchi L,Kamada N, Nakamura Y, et al. NLRC4-driven produc-tion of IL-1b discriminates between pathogenic and com-mensal bacteria and promotes host intestinal defense.Nature Immunology. 2012; 13:449–456. 3) Jamilloux Y,Pierini R, Querenet M, et al. Inflammasome activationrestricts legionella pneumophila replication in primarymicroglial cells through flagellin detection. Glia. 2013;61:539–549.Funding: DOD Grant ID# 10669042 and Internal fundingfrom Anesthesiology Institute of Cleveland Clinic.

227Preliminary Report on Effect of Dose on Ability toDiscriminate Between Active Control and PlaceboMichael Smith, BS, [email protected],Lynn R Webster, MD1, Matt Iverson, MPH2,Tim D Theisen, BA1, Julie Jenkins, MPC,Matthew Smollin, PharmD1, (1) CRILifetree, Salt LakeCity, UTIntroduction: The FDA has issued draft guidance toassist industry in the development of abuse-deterrentproducts. Human abuse liability (HAL) studies enrollsubjects who are recreationally experienced but notdependent on the drug class investigated. Becauseresearch subjects vary widely in their pharmacodynamicresponse to different molecules and doses, a screeningprocess determines which subjects can detect differencesin and pharmacodynamic effect between drug andplacebo. This process is drug discrimination. Materialsand Methods: Two HAL studies conducted at CRILifetree were compared for drug discrimination failures,including type of failures, based on subjective visualanalogue scales (VAS, 0–100 mm). Both studies wereapproved by an IRB and subjects were primarilyrecruited from CRI Lifetree subject database. One studyevaluated 120 mg of morphine versus placebo, while theother evaluated 45 mg hydrocodone versus placebo.Both studies utilized similar study methodology, routeof administration, and criteria to evaluate subject’s

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ability to discriminate; however, the doses and opioidsselected are substantially different. Results: In general,30% of subjects receiving morphine did not pass dis-crimination compared with 47% for hydrocodone. Mor-phine had a lower percentage of non-discriminatorsrelative to hydrocodone (14% vs. 38%) and a higherpercentage of subjects unable to tolerate the medication(7% vs. 3%). Conclusions: The level of dose selectedfor drug discrimination may play an important role in

failure rates. Dose selection should be thoughtfully con-sidered to ensure that the study population selected bydrug discrimination is sufficiently sensitive to identifydifferences between active control and abuse-deterrentformulations.Funding: Abstract and analysis of dose effect was not fundedbut clinical studies were conducted via funding from Pfizer andTeva

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