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  • Comparative Effectiveness Review Number 169

    Noninvasive Treatments for Low Back Pain

  • Comparative Effectiveness ReviewNumber 169

    Noninvasive Treatments for Low Back Pain

    Prepared for:

    Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov

    Contract No. 290-2012-00014-I

    Prepared by:

    Pacific Northwest Evidence-based Practice Center Portland, OR

    Investigators:

    Roger Chou, M.D., FACP Richard Deyo, M.D., M.P.H. Janna Friedly, M.D. Andrea Skelly, Ph.D., M.P.H. Robin Hashimoto, Ph.D. Melissa Weimer, D.O., M.C.R. Rochelle Fu, Ph.D. Tracy Dana, M.L.S. Paul Kraegel, M.S.W. Jessica Griffin, M.S. Sara Grusing, B.A. Erika Brodt, B.S.

    AHRQ Publication No. 16-EHC004-EF February 2016

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    This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00014-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

    None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

    The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

    This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.

    AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

    This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.

    Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected].

    Suggested citation: Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt E. Noninvasive Treatments for Low Back Pain. Comparative Effectiveness Review No. 169. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 16-EHC004-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

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    PrefaceThe Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies.

    Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm.

    AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input.

    If you have comments on this systematic review, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected].

    Richard G. Kronick, Ph.D. Director Agency for Healthcare Research and Quality

    Stephanie Chang, M.D., M.P.H. Director Evidence-based Practice Center Program Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality

    Arlene S. Bierman, M.D., M.S. Director Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality

    Suchitra Iyer, Ph.D. Task Order Officer Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality

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    Investigator AffiliationsRoger Chou, M.D., FACP Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University

    Richard Deyo, M.D., M.P.H. Department of Family Medicine Oregon Health & Science University

    Janna Friedly, M.D. Physical Medicine and Rehabilitation University of Washington

    Andrea Skelly, Ph.D., M.P.H. Spectrum Research

    Robin Hashimoto, Ph.D. Spectrum Research

    Melissa Weimer, D.O., M.C.R. Department of Medicine Oregon Health & Science University

    Rochelle Fu, Ph.D. Department of Public Health & Preventive Medicine Oregon Health & Science University

    Tracy Dana, M.L.S. Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University

    Paul Kraegel, M.S.W Department of Pharmacy University of Washington

    Jessica Griffin, M.S. Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University

    Sara Grusing, B.A. Department of Medical Informatics & Clinical Epidemiology Oregon Health & Science University

    Erika Brodt, B.S. Spectrum Research

    Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: Leah Williams, B.S., for editorial support; our Task Order Officer, Suchitra Iyer, Ph.D., for her support and guidance in developing this report; and our Associate Editor, Timothy Carey, M.D., M.P.H., for his review of this report.

    Key Informants In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants.

    Key Informants must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest.

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    The list of Key Informants who provided input to this report follows:

    Thiru Annaswamy, M.D. Department of Physical Medicine & Rehabili-tation University of Texas Southwestern Medical Center Dallas, TX

    Gert Bronfort, D.C., Ph.D. Neck and Back Research Program Northwestern Health Sciences University Bloomington, MN

    Richard Deyo, M.D., M.P.H. Department of Family MedicineOregon Health & Science University Portland, OR

    Julie M. Fritz, Ph.D., P.T., A.T.C. Research College of Health University of Utah Salt Lake City, UT

    Scott Haldeman, M.D., Ph.D., D.C. Neurology University of California at Irvine Santa Ana, CA

    Michael Jabbour, M.S., LAc New York State Acupuncture Coalition Forest Hills, NY

    Peter Marshall, M.D. Minneapolis VA Medical Center Minneapolis, MN

    Technical Expert PanelIn designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts.

    Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified.

    The list of Technical Experts who provided input to this report follows:

    Daniel Cherkin, M.S., Ph.D.* Group Health Research Institute Seattle, WA

    Julie M. Fritz, Ph.D., P.T., A.T.C. Research College of Health University of Utah Salt Lake City, UT

    Lee Glass, M.D.* Washington Department of Labor and Industries Olympia, WA

    Christine Goertz, D.C., Ph.D.* Patient-Centered Outcomes Research Institute Washington, DC

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    Rowland G. Hazard, M.D., FACP* Professor of Orthopedics and Medicine Giesel School of Medicine at Dartmouth Lebanon, NH

    W. Michael Hooten, M.D. Mayo Clinic Rochester, MN

    Partap S. Khalsa, D.C., Ph.D.* National Center for Complementary and Integrative Health National Institutes of Health Bethesda, MD

    Kurt Kroenke, M.D., M.A.C.P. Indiana University Center for Health Services and Outcomes Research Indianapolis, IN Robert McLean, M.D. Hospital of Saint Raphael New Haven, CT

    Gavril Pasternak, M.D., Ph.D.* Memorial Sloan Kettering Cancer Center New York, NY

    Judith Turner, Ph.D.* University of Washington Seattle, WA

    Timothy Wilt, M.D., M.P.H.* VA Medical Center Minneapolis, MN

    *Provided comments on draft report.

    Peer ReviewersPrior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report do not necessarily represent the views of individual reviewers.

    Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest identified.

    The list of Peer Reviewers follows:

    Steven Atlas, M.D. Massachusetts General Hospital Boston, MA

    John Mayer, D.C., Ph.D. University of South Florida Tampa, FL

    Kathryn Mueller, M.D., M.P.H. Environmental and Occupational Health Colorado School of Public Health Aurora, CO

    Karen Sherman, Ph.D., M.P.H. Group Health Research Institute Seattle, WA

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    Noninvasive Treatments for Low Back Pain

    Structured AbstractObjectives. Low back pain is common, and many pharmacological and nonpharmacological therapies are available. This review examines the evidence on the comparative benefits and harms of noninvasive treatments for low back pain.

    Data sources. A prior systematic review (searches through October 2008), electronic databases (Ovid MEDLINE® and the Cochrane Libraries, January 2008 to April 2015), reference lists, and clinical trials registries.

    Review methods. Using predefined criteria, we selected systematic reviews of randomized trials of pharmacological treatments (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], opioids, skeletal muscle relaxants, benzodiazepines, antidepressants, antiseizure medications, and systemic corticosteroids) and nonpharmacological treatments (psychological therapies, multidisciplinary rehabilitation, spinal manipulation, acupuncture, massage, exercise and related therapies, and various physical modalities) for nonradicular or radicular low back pain that addressed effectiveness or harms versus placebo, no treatment, usual care, a sham therapy, an inactive therapy, or another active therapy. We also included randomized trials that were not in systematic reviews. The quality of included studies was assessed, data were extracted, and results were summarized qualitatively based on the totality of the evidence.

    Results. Of the 2,545 citations identified at the title and abstract level, a total of 156 publications were included. Most trials enrolled patients with pain symptoms of at least moderate intensity (e.g., >5 on a 0- to 10-point numeric rating scale for pain). Across interventions, pain intensity was the most commonly reported outcome, followed by back-specific function. When present, observed benefits for pain were generally in the small (5 to 10 points on a 0- to 100-point visual analog scale or 0.5 to 1.0 points on a 0- to 10-point numeric rating scale) to moderate (10 to 20 points) range. Effects on function were generally smaller than effects on pain; in some cases, there were positive effects on pain but no effects on function, and fewer studies measured function than pain. Benefits were mostly measured at short-term followup. For acute low back pain, evidence suggested that NSAIDs (strength of evidence [SOE]: low to moderate), skeletal muscle relaxants (SOE: moderate), opioids (SOE: low), exercise (SOE: low), and superficial heat (SOE: moderate) are more effective than placebo, no intervention, or usual care, and that acetaminophen (SOE: low) and systemic corticosteroids (SOE: low) are no more effective than placebo. For chronic low back pain, effective therapies versus placebo, sham, no treatment, usual care, or wait list are NSAIDs, opioids, tramadol, duloxetine, multidisciplinary rehabilitation, acupuncture, and exercise (SOE: moderate) and benzodiazepines, psychological therapies, massage, yoga, tai chi, and low-level laser therapy (SOE: low); spinal manipulation was as effective as other active interventions (SOE: moderate). Few trials evaluated the effectiveness of treatments for radicular low back pain, but the available evidence found that benzodiazepines, corticosteroids, traction, and spinal manipulation were not effective or were associated with small effects (SOE: low). Relatively few trials directly compared the effectiveness of different medications or different nonpharmacological therapies, or compared pharmacological versus nonpharmacological therapies, and they generally found no clear differences in effects.

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    Pharmacological therapies were associated with increased risk of adverse events versus placebo (SOE: low to moderate). Trials were not designed or powered to detect serious harms from pharmacological therapies. Although rates appeared to be low and there was not an increased risk of serious harms versus placebo, this does not rule out significant risk from some treatments. For nonpharmacological therapies, assessment of harms was suboptimal, but serious harms appeared to be rare (SOE: low).

    Conclusions. A number of pharmacological and nonpharmacological noninvasive treatments for low back pain are associated with small to moderate, primarily short-term effects on pain versus placebo, sham, wait list, or no treatment. Effects on function were generally smaller than effects on pain. More research is needed to understand optimal selection of treatments, effective combinations and sequencing of treatments, effectiveness of treatments for radicular low back pain, and effectiveness on outcomes other than pain and function.

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    ContentsExecutive Summary ........................................................................................................................... ES-1Introduction ................................................................................................................................ 1 Background ............................................................................................................................................. 1 Nature and Burden of Low Back Pain ............................................................................................... 1 Interventions For Low Back Pain ...................................................................................................... 1 Rationale For Evidence Review ......................................................................................................... 2 Scope of Review and Key Questions ................................................................................................... 2 PICOTS ................................................................................................................................................. 3 Analytic Framework ............................................................................................................................ 5Methods ....................................................................................................................................... 6 Topic Refinement and Review Protocol .............................................................................................. 6 Literature Search Strategy ..................................................................................................................... 6 Study Selection ....................................................................................................................................... 7 Population and Condition of Interest ............................................................................................... 7 Interventions and Comparisons ........................................................................................................ 7 Outcomes, Timing, and Setting ......................................................................................................... 8 Study Designs ....................................................................................................................................... 8 Data Extraction and Data Management ............................................................................................. 9 Assessing Methodological Quality of Individual Studies ................................................................. 9 Assessing Applicability ........................................................................................................................ 10 Evidence Synthesis and Rating the Body of Evidence ..................................................................... 12 Grading the Strength of Evidence for Each Key Question ............................................................. 12 Peer Review and Public Commentary............................................................................................... 13Results ........................................................................................................................................ 14 Results of Literature Searches ............................................................................................................. 16 Key Question 1. What are the comparative benefits and harms of different pharmacological

    therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids, and topical/patch-delivered medications ................................. 16

    Acetaminophen.................................................................................................................................. 16 NSAIDs ............................................................................................................................................... 18 Opioids, Tramadol, and Tapentadol................................................................................................ 22 Skeletal Muscle Relaxants ................................................................................................................. 28 Benzodiazepines ................................................................................................................................ 31 Antidepressants.................................................................................................................................. 33 Antiseizure Medications ................................................................................................................... 36 Corticosteroids................................................................................................................................... 41 Topical Medications .......................................................................................................................... 43

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    Key Question 2. What are the comparative benefits and harms of different nonpharmacological noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes but is not limited to multidisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, transcutaneous electrical nerve stimulation, electrical muscle stimulation, interferential therapy, heat [various forms], and ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets, and low-level lasers. ................ 43

    Exercise and Related Interventions: Exercise ................................................................................ 44 Exercise and Related Interventions: Pilates .................................................................................... 54 Exercise and Related Interventions: Tai Chi .................................................................................. 55 Exercise and Related Interventions: Yoga ...................................................................................... 57 Psychological Therapies .................................................................................................................... 60 Multidisciplinary Rehabilitation ..................................................................................................... 66 Acupuncture ....................................................................................................................................... 71 Massage ............................................................................................................................................... 76 Spinal Manipulation .......................................................................................................................... 80 Physical Modalities: Ultrasound ...................................................................................................... 87 Physical Modalities: Transcutaneous Electrical Nerve Stimulation ........................................... 91 Physical Modalities: Electrical Muscle Stimulation ...................................................................... 93 Physical Modalities: Percutaneous Electrical Nerve Stimulation ............................................... 95 Physical Modalities: Interferential Therapy ................................................................................... 98 Physical Modalities: Superficial Heat or Cold ............................................................................. 100 Low-Level Laser Therapy ............................................................................................................... 103 Short-Wave Diathermy ................................................................................................................... 107 Lumbar Supports ............................................................................................................................. 108 Traction ............................................................................................................................................. 111 Taping ................................................................................................................................................ 114Discussion ................................................................................................................................ 204 Key Findings and Strength of Evidence .......................................................................................... 204 Findings in Relationship to What Is Already Known ................................................................... 207 Applicability ........................................................................................................................................ 210 Implications for Clinical and Policy Decisionmaking .................................................................. 211 Limitations of the Review Process ................................................................................................... 212 Limitations of the Evidence Base ..................................................................................................... 213 Research Gaps..................................................................................................................................... 214Conclusions ............................................................................................................................. 242References ................................................................................................................................ 243Abbreviations .......................................................................................................................... 273TablesTable A. Pharmacological therapies versus placebo for acute low back pain ............................... ES-8Table B. Pharmacological therapies versus active comparators for acute low back pain ............ ES-8Table C. Pharmacological therapies versus placebo for chronic low back pain ........................... ES-9Table D. Pharmacological therapies versus active comparators for chronic low back pain ....... ES-9Table E. Pharmacological therapies versus placebo for radicular low back pain ....................... ES-10

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    Table F. Nonpharmacological treatments versus sham, no treatment, or usual care for acute or subacute low back pain.................................................................................................................. ES-11

    Table G. Nonpharmacological treatments versus sham, no treatment, or usual care for chronic low back pain ......................................................................................................................................... ES-11

    Table H. Nonpharmacological treatments versus active comparators for chronic low back pain .................................................................................................................................................. ES-13

    Table I. Summary of evidence ........................................................................................................... ES-15Table 1. Summary of systematic reviews of pharmacological treatments for low back pain ....... 117Table 2. Characteristics and conclusions of included acetaminophen trials .................................. 121Table 3. Characteristics and conclusions of included NSAID trials ................................................ 122Table 4. Characteristics and conclusions of included opioid trials .................................................. 124Table 5. Characteristics and conclusions of included skeletal muscle relaxant trials .................... 126Table 6. Characteristics and conclusions of included benzodiapine trials...................................... 127Table 7. Characteristics and conclusions of included antidepressant trials .................................... 128Table 8. Characteristics and conclusions of included antiseizure trials .......................................... 132Table 9. Characteristics and conclusions of included corticosteroid trials ..................................... 136Table 10. Summary of systematic reviews of nonpharmacological treatments for low

    back pain ............................................................................................................................................. 138Table 11. Characteristics and conclusions of included exercise trials ............................................. 148Table 12. Characteristics and conclusions of included tai chi trials ................................................ 162Table 13. Characteristics and conclusions of included yoga trials ................................................... 164Table 14. Characteristics and conclusions of included psychological therapy trials ..................... 166Table 15. Characteristics and conclusions of included multidisciplinary rehabilitation trials .... 170Table 16. Characteristics and conclusions of included acupuncture trials ..................................... 172Table 17. Characteristics and conclusion s of included massage trials ............................................ 174Table 18. Characteristics and conclusions of included spinal manipulation trials ........................ 176Table 19. Characteristics and conclusions of included ultrasound trials ........................................ 180Table 20. Characteristics and conclusions of included transcutaneous electrical nerve stimulation

    (TENS) trials ....................................................................................................................................... 183Table 21. Characteristics and conclusions of included electrical muscle stimulation trials ......... 185Table 22. Characteristics and conclusions of included percutaneous electrical nerve

    stimulation (PENS) trials .................................................................................................................. 189Table 23. Characteristics and conclusions of included interferential therapy trials ...................... 191Table 24. Characteristics and conclusions of included superficial heat or cold trials ................... 192Table 25. Characteristics and conclusions of included low-level laser therapy trials .................... 194Table 26. Characteristics and conclusions of included diathermy trials ......................................... 197Table 27. Characteristics and conclusions of included lumbar supports trials .............................. 198Table 28. Characteristics and conclusions of included traction trials ............................................. 200Table 29. Characteristics and conclusions of included taping trials ................................................ 201Table 30. Summary of evidence ............................................................................................................ 213Table 31. Pharmacological therapies versus placebo for acute low back pain ................................ 235Table 32. Pharmacological therapies versus active comparators for acute low back pain ............ 235Table 33. Nonpharmacological treatments versus sham, no treatment, or usual care for acute or

    subacute low back pain...................................................................................................................... 235

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    Table 34. Nonpharmacological treatments versus active comparators for acute or subacute low back pain ............................................................................................................................................. 236

    Table 35. Pharmacological therapies versus placebo for chronic low back pain ............................ 237Table 36. Pharmacological therapies versus active comparators for chronic low back pain ........ 237Table 37. Nonpharmacological treatments versus sham, no treatment, or usual care for chronic

    low back pain ...................................................................................................................................... 238Table 38. Nonpharmacological treatments versus active comparators for chronic low back

    pain ...................................................................................................................................................... 240Table 39. Pharmacological therapies versus placebo for radicular low back pain ......................... 241Table 40. Nonpharmacological treatments versus sham, no treatment, or usual care for radicular

    low back pain ...................................................................................................................................... 241Table 41. Nonpharmacological treatments versus active comparators for radicular low back

    pain ...................................................................................................................................................... 241FiguresFigure A. Analytic framework ............................................................................................................ ES-3Figure 1. Analytic framework ................................................................................................................... 5Figure 2. Literature flow diagram ........................................................................................................... 14Appendixes Appendix A. Search StrategiesAppendix B. Inclusion and Exclusion CriteriaAppendix C. Included StudiesAppendix D. Excluded StudiesAppendix E. Data AbstractionAppendix F. Quality AssessmentAppendix G. Outcome MeasuresAppendix H. Strength of EvidenceAppendix I. Abbreviations Used in the Appendixes

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    Executive Summary

    Background

    Nature and Burden of Low Back PainLow back pain is one of the most frequently encountered conditions in clinical practice. Up

    to 84 percent of adults have low back pain at some time in their lives, and over one-quarter of U.S. adults report recent (in the last 3 months) low back pain.1,2 Low back pain can have major adverse impacts on quality of life and function. Low back pain is also costly: total U.S. health care expenditures for low back pain in 1998 were estimated at $90 billion.3 Since that time, costs of low back pain care have risen at a rate higher than observed for overall health expenditures.4 In addition to high direct costs, low back pain is one of the most common reasons for missed work or reduced productivity while at work, resulting in high indirect costs.5

    The prognosis for acute low back pain (generally defined as an episode lasting less than 4 weeks) is generally favorable. Most patients experience a rapid improvement in (and often a complete resolution of) pain and disability, and are able to return to work.6 In those with persistent symptoms, continued improvement is often seen in the subacute phase between 4 and 12 weeks, although at a slower rate than observed at first. In a minority of patients, low back pain lasts longer than 12 weeks, at which point it is considered chronic; levels of pain and disability often remain relatively constant thereafter.7 Recently, a National Institutes of Health Research Task Force defined chronic low back pain as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.8 Patients with chronic back pain account for the bulk of the burdens and costs of low back pain.9,10 Predictors of chronicity are primarily related to psychosocial factors, such as presence of psychological comorbidities, maladaptive coping strategies (e.g., fear avoidance [avoiding activities because of fears that they will further damage the back] or catastrophizing [anticipating the worst possible outcomes from low back pain]), presence of nonorganic signs (symptoms without a distinct anatomical or physiological basis),11 high baseline functional impairment, and low general health status.7 Back pain is frequently associated with presence of depression and anxiety.

    Attributing symptoms of low back pain to a specific disease or spinal pathology is a challenge.12 Spinal imaging abnormalities, such as degenerative disc disease, facet joint arthropathy, and bulging or herniated intervertebral discs, are extremely common in patients with or without low back pain, particularly in older adults, and such findings are poor predictors for the presence or severity of low back pain.13 Radiculopathy from nerve root impingement (often due to a herniated intervertebral disc) and radiculopathy from spinal stenosis (narrowing of the spinal canal) are each present in about 4 to 5 percent of patients with low back pain and can cause neurological symptoms, such as lower extremity pain, paresthesias, and weakness; the natural history and response to treatment for these conditions may differ from back pain without neurologic involvement.14

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    Interventions for Low Back PainMultiple treatment options for acute and chronic low back pain are available. Broadly, these

    can be classified as pharmacological treatments,15 noninvasive nonpharmacological treatments,16 injection therapies,17 and surgical treatments.18 This report focuses on the comparative benefits and harms of pharmacological and noninvasive nonpharmacological treatments; each of these categories encompasses a number of different therapies. Pharmacological treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, and corticosteroids; nonpharmacological treatments include exercise and related interventions (e.g., yoga), complementary and alternative therapies (e.g., spinal manipulation, acupuncture, and massage), psychological therapies (e.g., cognitive-behavioral therapy, relaxation techniques, and multidisciplinary rehabilitation), and physical modalities (e.g., traction, ultrasound, transcutaneous electrical nerve stimulation [TENS], low-level laser therapy, interferential therapy, superficial heat or cold, back supports, and magnets).

    Scope of Review and Key QuestionsThe provisional Key Questions; populations, interventions, comparators, outcomes, timing,

    settings, and study designs (PICOTS); and analytic framework for this topic (Figure A) were posted on the Agency for Healthcare Research and Quality (AHRQ) Web site for public comment from December 17, 2013, through January 17, 2014.

    Key Question 1. What are the comparative benefits and harms of different pharmacological therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids, and topical/patch-delivered medications.

    Key Question 2. What are the comparative benefits and harms of different nonpharmacological noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Includes but is not limited to multidisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, transcutaneous electrical nerve stimulation, electrical muscle stimulation, interferential therapy, heat [various forms], and ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets, and low-level lasers.

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    Figure A. Analytic framework

    *Patient characteristics include clinical, demographic, and psychosocial risk factors associated with low back pain outcomes.

    †Intermediate outcomes (e.g., inflammation) are typically not measured.

    KQ = Key Question.

    MethodsThis Comparative Effectiveness Review follows the methods suggested in the AHRQ

    “Methods Guide for Effectiveness and Comparative Effectiveness Reviews” (hereafter, “AHRQ Methods Guide”).19 Our methods are summarized in this section; for additional details, see the review protocol posted on the AHRQ Effective Health Care Program Web site (www.effectivehealthcare.ahrq.gov).

    Literature Search and SelectionA research librarian conducted searches in Ovid MEDLINE®, the Cochrane Central Register

    of Controlled Trials, and the Cochrane Database of Systematic Reviews through August 2014. We restricted search start dates to January 2008 because searches in a prior American Pain Society/American College of Physicians (APS/ACP) review were conducted through October 2008; the APS/ACP review was used to identify studies published prior to 2008.20 For interventions not addressed in the APS/ACP review, we searched the same databases without a search date start restriction. We also hand searched the reference lists of relevant studies and searched for unpublished studies in ClinicalTrials.gov. Scientific information packets were solicited from drug and device manufacturers, and a notice published in the Federal Register invited interested parties to submit relevant published and unpublished studies. We conducted an update search in April 2015 using the same search strategy as in the original search.

    We developed criteria for inclusion and exclusion of studies based on the Key Questions and PICOTS. Abstracts were reviewed by two investigators, and all citations deemed potentially

  • ES-4

    appropriate for inclusion by at least one of the reviewers were retrieved. Two investigators then independently reviewed all full-text articles for final inclusion. Discrepancies were resolved by discussion and consensus.

    Population and condition of interest. This report focuses on adults with low back pain of any duration (categorized as acute [

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    comparison, and results), methods of quality assessment, quality ratings for included studies, methods for synthesis, and results. For primary studies not included in systematic reviews, we abstracted the following data: study design, year, setting, country, sample size, eligibility criteria, population and clinical characteristics, intervention characteristics, and results. Information relevant for assessing applicability was also abstracted, including the characteristics of the population, interventions, and care settings; the use of run-in or washout periods; and the number of patients enrolled relative to the number assessed for eligibility. All study data were verified for accuracy and completeness by a second team member.

    Risk-of-Bias Assessment of Individual StudiesTwo investigators independently assessed quality (risk of bias) of systematic reviews and

    primary studies not included in systematic reviews using predefined criteria, with disagreements resolved by consensus. Randomized trials were evaluated using criteria and methods developed by the Cochrane Back Review Group,24 and cohort studies were evaluated using criteria developed by the U.S. Preventive Services Task Force.25 Systematic reviews were assessed using the AMSTAR quality rating instrument.22 These criteria and methods were used in conjunction with the approach recommended in the AHRQ Methods Guide.21 Studies were rated as good, fair, or poor. We re-reviewed the quality ratings of studies included in the prior APS/ACP review to ensure consistency in quality assessment.23

    For primary studies included in systematic reviews, we relied on the quality ratings or risk-of-bias assessments performed in the systematic reviews as long as they used a standardized method for assessing quality (e.g., Cochrane Back Review Group, Cochrane Risk of Bias tool, PEDro [Physiotherapy Evidence Database] tool). If we were uncertain about the methods used to assess risk of bias or quality, we assessed the quality of individual studies ourselves, using the methods described previously.

    We did not exclude studies rated poor quality a priori, but they were considered the least reliable when synthesizing the evidence, particularly when discrepancies among studies were present.

    Data SynthesisWe synthesized data qualitatively, based on the totality of evidence (i.e., evidence included

    in the prior APS/ACP review plus new evidence). We synthesized results for continuous as well as dichotomous outcomes. We reported binary outcomes based on the proportion of patients achieving successful pain reduction, improvement in function, or some composite overall measure of success as defined in the trials, which varied in how they categorized successful outcomes.

    In addition, we reported meta-analysis from systematic reviews that reported pooled estimates from studies that were judged to be homogeneous enough to provide a meaningful combined estimate and used appropriate pooling methods (e.g., random-effects model in the presence of statistical heterogeneity). When statistical heterogeneity was present, we examined the type of inconsistency present and evaluated subgroup and sensitivity analyses based on

  • ES-6

    study characteristics, intervention factors, and patient factors. We did not conduct updated meta-analysis with new studies. Rather, we qualitatively examined whether results of new studies were consistent with pooled or qualitative findings from prior systematic reviews. When we included more than one systematic review for a particular intervention and comparison, we evaluated the consistency of results among reviews.

    We assessed the strength of evidence (i.e., evidence in prior reviews as well as new evidence) for each Key Question and outcome using the approach described in the AHRQ Methods Guide19 based on the overall quality of each body of evidence.

    ResultsDatabase searches resulted in 2,545 potentially relevant articles. After dual review of

    abstracts and titles, 1,310 articles were selected for full-text dual review; 156 publications were determined to meet inclusion criteria and were included in this review.

    Most trials were conducted in patients with nonradicular low back pain or mixed populations with primarily nonradicular low back pain. Some trials enrolled mixed populations of patients with acute and subacute symptoms, with few trials restricted to patients with subacute low back pain. Therefore, acute and subacute low back pain were grouped together when summarizing findings. Pain was the most commonly reported outcome in the trials, followed by function, with evidence on other efficacy outcomes generally too limited to reach reliable conclusions. In addition, most trials focused on short-term outcomes, frequently with followup limited to the active treatment period. Assessment and reporting of harms were suboptimal, particularly for the nonpharmacological therapies. Summarizing evidence on nonpharmacological therapies was also complicated by variability in the techniques used; in the number, length, and intensity of sessions; and in the duration of treatment. Common methodological shortcomings included failure to report randomization or allocation concealment methods, unblinded or unclearly blinded design, and high or unclear attrition.

    Key Question 1. Pharmacological TherapiesFor acute or subacute low back pain, NSAIDs, opioids (buprenorphine patch), and skeletal

    muscle relaxants were associated with small effects on pain versus placebo, and NSAIDs were associated with small effects on function (Table A). Acetaminophen and systemic corticosteroids were associated with no beneficial effects versus placebo. Head-to-head comparisons were limited but indicated no clear differences between acetaminophen versus NSAIDs or between different NSAIDs (Table B).

    For chronic low back pain, NSAIDs and tramadol were associated with moderate effects on pain versus placebo, and opioids, duloxetine, and benzodiazepines were associated with small effects (Table C). Effects on function were small for NSAIDs, opioids, tramadol, and duloxetine. Tricyclic antidepressants were not associated with beneficial effects, and there was insufficient evidence to determine effects of gabapentin or pregabalin. Head-to-head comparisons were limited but showed no clear differences between different NSAIDs, different long-acting opioids, or long-acting versus short-acting opioids. Evidence was too inconsistent to determine effects of opioids versus NSAIDs (Table D).

  • ES-7

    Evidence on effects of pharmacological therapies for radiculopathy was extremely limited (Table E). There were no differences in pain or function between systemic corticosteroids versus placebo, and evidence was insufficient to determine effects of gabapentin or pregabalin.

    Pharmacological therapies were associated with an increased risk of adverse events versus placebo. However, serious harms were rare in clinical trials, with no clear increase in risk based on clinical trials. In particular, trials of opioids were not designed to assess for serious harms, such as overdose, abuse, and addiction. Such harms have been reported in observational studies of opioids for chronic pain, although such studies did not meet inclusion criteria because they were not restricted to patients with low back pain.26

    Key Question 2. Nonpharmacological Noninvasive TherapiesEvidence on the effectiveness of nonpharmacological therapies for acute low back pain was

    limited. There was limited evidence that spinal manipulation, heat, massage, and low-level laser therapy are associated with some beneficial effects versus a sham therapy, no intervention, or usual care (Table F). Effects on pain or function were moderate for exercise, massage, and heat, and otherwise small.

    For chronic low back pain, a number of nonpharmacological therapies appear to be effective for improving pain or function (Table G). These include exercise, yoga, and tai chi; various psychological therapies; multidisciplinary rehabilitation; acupuncture; spinal manipulation (vs. an inert treatment); and low-level laser therapy. Effects were small to moderate in magnitude. Other physical modalities were not associated with beneficial effects, or evidence was insufficient to estimate effects. Based on head-to-head comparisons, multidisciplinary rehabilitation was associated with small to moderate beneficial effects on pain and function versus standard physical therapy, and spinal manipulation and massage were associated with small beneficial effects versus other active interventions (Table H). There was no strong evidence of differences in effectiveness among different exercise, massage, spinal manipulation, or acupuncture techniques, or among different types of psychological therapies.

    Assessment and reporting of harms for nonpharmacological therapies were suboptimal but indicated no serious harms. Reported harms were generally related to superficial symptoms at the application site or a temporary increase in pain.

  • ES-8

    Tabl

    e A

    . Pha

    rmac

    olog

    ical

    ther

    apie

    s ve

    rsus

    pla

    cebo

    for a

    cute

    low

    bac

    k pa

    in

    Dru

    gPa

    in: M

    agni

    tude

    of

    Effe

    ctPa

    in: E

    vide

    nce

    Pain

    : SO

    EFu

    nctio

    n:

    Mag

    nitu

    de o

    f Effe

    ctFu

    nctio

    n:

    Evid

    ence

    Func

    tion:

    SO

    EA

    ceta

    min

    ophe

    nN

    o ef

    fect

    1 R

    CT

    Low

    No

    effe

    ct1

    RC

    TLo

    wN

    SA

    IDs

    Sm

    all (

    pain

    inte

    nsity

    ); no

    ef

    fect

    (pai

    n re

    lief)

    1 S

    R (4

    RC

    Ts)

    Mod

    erat

    eS

    mal

    l2

    RC

    TsLo

    w

    Opi

    oids

    (bup

    reno

    rphi

    ne

    patc

    h)S

    mal

    l2

    RC

    TsLo

    wN

    o ev

    iden

    ce--

    --

    Ske

    leta

    l mus

    cle

    rela

    xant

    sP

    ain

    relie

    f: R

    R, 1

    .72

    (95%

    CI,

    1.32

    to 2

    .22)

    at 5

    –7 d

    ays

    1 S

    R (3

    RC

    Ts) +

    1

    RC

    TM

    oder

    ate

    No

    evid

    ence

    ----

    Ben

    zodi

    azep

    ines

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

    Ant

    isei

    zure

    med

    icat

    ions

    No

    evid

    ence

    ----

    No

    evid

    ence

    ----

    Sys

    tem

    ic c

    ortic

    oste

    roid

    sN

    o ef

    fect

    2 R

    CTs

    Low

    No

    effe

    ct2

    RC

    TsLo

    wC

    I =

    con

    fide

    nce

    inte

    rval

    ; NS

    AID

    = n

    onst

    eroi

    dal a

    nti-

    infl

    amm

    ator

    y dr

    ug; R

    CT

    = r

    ando

    miz

    ed c

    ontr

    olle

    d tr

    ial;

    RR

    = r

    elat

    ive

    risk

    ; SO

    E =

    str

    engt

    h of

    evi

    denc

    e; S

    R =

    sys

    tem

    atic

    re

    view

    .

    Tabl

    e B

    . Pha

    rmac

    olog

    ical

    ther

    apie

    s ve

    rsus

    act

    ive

    com

    para

    tors

    for a

    cute

    low

    bac

    k pa

    in

    Dru

    gPa

    in: M

    agni

    tude

    of

    Effe

    ctPa

    in: E

    vide

    nce

    Pain

    : SO

    EFu

    nctio

    n:

    Mag

    nitu

    de o

    f Effe

    ctFu

    nctio

    n:

    Evid

    ence

    Func

    tion:

    SO

    EA

    ceta

    min

    ophe

    n vs

    . NS

    AID

    Una

    ble

    to e

    stim

    ate

    1 R

    CT

    Insu

    ffici

    ent

    Una

    ble

    to e

    stim

    ate

    1 R

    CT

    Insu

    ffici

    ent

    NS

    AID

    vs.

    NS

    AID

    No

    diffe

    renc

    e6

    RC

    TsM

    oder

    ate

    ----

    --O

    pioi

    d vs

    . NS

    AID

    Una

    ble

    to e

    stim

    ate

    (inco

    nsis

    tent

    )3

    RC

    TsIn

    suffi

    cien

    tN

    o di

    ffere

    nce

    1 R

    CT

    Insu

    ffici

    ent

    Long

    -act

    ing

    opio

    id v

    s. lo

    ng-a

    ctin

    g op

    ioid

    No

    clea

    r diff

    eren

    ce4

    RC

    TsM

    oder

    ate

    No

    clea

    r diff

    eren

    ce4

    RC

    TsM

    oder

    ate

    Long

    -act

    ing

    opio

    id v

    s. s

    hort-

    actin

    g op

    ioid

    No

    clea

    r diff

    eren

    ce*

    6 R

    CTs

    Low

    ----

    --

    Ben

    zodi

    azep

    ine

    (dia

    zepa

    m) v

    s.

    skel

    etal

    mus

    cle

    rela

    xant

    No

    diffe

    renc

    e1

    RC

    TLo

    w--

    ----

    Ske

    leta

    l mus

    cle

    rela

    xant

    vs.

    ske

    leta

    l m

    uscl

    e re

    laxa

    ntN

    o cl

    ear d

    iffer

    ence

    1 S

    R (2

    RC

    Ts)

    Low

    ----

    --

    CI =

    con

    fiden

    ce in

    terv

    al; N

    SA

    ID =

    non

    ster

    oida

    l ant

    i-infl

    amm

    ator

    y dr

    ug; R

    CT

    = ra

    ndom

    ized

    con

    trolle

    d tri

    al; R

    R =

    rela

    tive

    risk;

    SO

    E =

    stre

    ngth

    of e

    vide

    nce;

    SR

    =

    syst

    emat

    ic re

    view

    ; SS

    RI =

    sel

    ectiv

    e se

    roto

    nin

    reup

    take

    inhi

    bito

    r.

  • ES-9

    Tabl

    e C

    . Pha

    rmac

    olog

    ical

    ther

    apie

    s ve

    rsus

    pla

    cebo

    for c

    hron

    ic lo

    w b

    ack

    pain

    Dru

    gPa

    in: M

    agni

    tude

    of

    Effe

    ctPa

    in: E

    vide

    nce

    Pain

    : SO

    EFu

    nctio

    n:

    Mag

    nitu

    de o

    f Effe

    ctFu

    nctio

    n: E

    vide

    nce

    Func

    tion:

    SO

    EA

    ceta

    min

    ophe

    nN

    o ev

    iden

    ce--

    --N

    o ev

    iden

    ce--

    --N

    SA

    IDs

    Mod

    erat

    e1

    SR

    (4 R

    CTs

    )M

    oder

    ate

    Sm

    all

    1 S

    R (2

    RC

    Ts)

    Low

    Opi

    oids

    Sm

    all

    1 S

    R (6

    RC

    Ts)

    Mod

    erat

    eS

    mal

    l1

    SR

    (4 R

    CTs

    )M

    oder

    ate

    Ske

    leta

    l mus

    cle

    rela

    xant

    sU

    nabl

    e to

    est

    imat

    e3

    RC

    TsIn

    suffi

    cien

    t--

    ----

    Tram

    adol

    Mod

    erat

    e1

    SR

    (5 R

    CTs

    ) + 2

    R

    CTs

    Mod

    erat

    eS

    mal

    l1

    SR

    (5 R

    CTs

    ) + 2

    R

    CTs

    Mod

    erat

    e

    Ben

    zodi

    azep

    ines

    : te

    traze

    pam

    Failu

    re to

    impr

    ove

    at

    10–1

    4 da

    ys: R

    R, 0

    .71

    (95%

    CI,

    0.54

    to 0

    .93)

    1 S

    R (2

    RC

    Ts)

    Low

    ----

    --

    Tric

    yclic

    ant

    idep

    ress

    ants

    No

    effe

    ct1

    SR

    (4 R

    CTs

    )M

    oder

    ate

    No

    effe

    ct1

    SR

    (2 R

    CTs

    )Lo

    wA

    ntid

    epre

    ssan

    ts: S

    SR

    IN

    o ef

    fect

    1 S

    R (3

    RC

    Ts)

    Mod

    erat

    e--

    ----

    Ant

    idep

    ress

    ants

    : dul

    oxet

    ine

    Sm

    all

    3 R

    CTs

    Mod

    erat

    eS

    mal

    l3

    RC

    TsM

    oder

    ate

    Gab

    apen

    tin/p

    rega

    balin

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

    CI =

    con

    fiden

    ce in

    terv

    al; N

    SA

    ID =

    non

    ster

    oida

    l ant

    i-infl

    amm

    ator

    y dr

    ug; R

    CT

    = ra

    ndom

    ized

    con

    trolle

    d tri

    al; R

    R =

    rela

    tive

    risk;

    SO

    E =

    stre

    ngth

    of e

    vide

    nce;

    SR

    =

    syst

    emat

    ic re

    view

    ; SS

    RI =

    sel

    ectiv

    e se

    roto

    nin

    reup

    take

    inhi

    bito

    r.

  • Tabl

    e D

    . Pha

    rmac

    olog

    ical

    ther

    apie

    s ve

    rsus

    act

    ive

    com

    para

    tors

    for c

    hron

    ic lo

    w b

    ack

    pain

    Dru

    g Pa

    in: M

    agni

    tude

    of

    Effe

    ct

    Pain

    : Ev

    iden

    ce

    Pain

    : SO

    E

    Func

    tion:

    M

    agni

    tude

    of

    Effe

    ct

    Func

    tion:

    Ev

    iden

    ce

    Func

    tion:

    SO

    E A

    ceta

    min

    ophe

    n vs

    . N

    SA

    ID

    Una

    ble

    to

    estim

    ate

    1 R

    CT

    Insu

    ffici

    ent

    Una

    ble

    to

    estim

    ate

    1 R

    CT

    Insu

    ffici

    ent

    NS

    AID

    vs.

    NS

    AID

    N

    o di

    ffere

    nce

    6 R

    CTs

    M

    oder

    ate

    --

    --

    --

    Opi

    oid

    vs. N

    SA

    ID

    Una

    ble

    to

    estim

    ate

    (inco

    nsis

    tent

    ) 3

    RC

    Ts

    Insu

    ffici

    ent

    No

    diffe

    renc

    e 1

    RC

    T In

    suffi

    cien

    t

    Long

    -act

    ing

    opio

    id v

    s.

    long

    -act

    ing

    opio

    id

    No

    clea

    r di

    ffere

    nce

    4 R

    CTs

    M

    oder

    ate

    No

    clea

    r di

    ffere

    nce

    4 R

    CTs

    M

    oder

    ate

    Long

    -act

    ing

    opio

    id v

    s.

    shor

    t-act

    ing

    opio

    id

    No

    clea

    r di

    ffere

    nce*

    6

    RC

    Ts

    Low

    --

    --

    --

    Ben

    zodi

    azep

    ine

    (dia

    zepa

    m) v

    s. s

    kele

    tal

    mus

    cle

    rela

    xant

    N

    o di

    ffere

    nce

    1 R

    CT

    Low

    --

    --

    --

    Ske

    leta

    l mus

    cle

    rela

    xant

    vs

    . ske

    leta

    l mus

    cle

    rela

    xant

    No

    clea

    r di

    ffere

    nce

    1 S

    R (2

    R

    CTs

    ) Lo

    w

    --

    --

    --

    *Alth

    ough

    som

    e R

    CTs

    foun

    d lo

    ng-a

    ctin

    g op

    ioid

    s to

    be a

    ssoc

    iate

    d w

    ith g

    reat

    er p

    ain

    relie

    f tha

    n sh

    ort-a

    ctin

    g op

    ioid

    s, pa

    tient

    sra

    ndom

    ized

    to lo

    ng-a

    ctin

    g op

    ioid

    s als

    o re

    ceiv

    ed h

    ighe

    r dos

    es o

    f opi

    oids

    . N

    SAID

    = n

    onst

    eroi

    dal a

    nti-i

    nfla

    mm

    ator

    y dr

    ug; R

    CT

    = ra

    ndom

    ized

    con

    trolle

    d tri

    al; S

    OE

    = st

    reng

    th o

    f evi

    denc

    e; S

    R =

    syst

    emat

    ic

    revi

    ew.

    ES-10

  • ES-11

    Tabl

    e E.

    Pha

    rmac

    olog

    ical

    ther

    apie

    s ve

    rsus

    pla

    cebo

    for r

    adic

    ular

    low

    bac

    k pa

    in

    Dru

    gPa

    in: M

    agni

    tude

    of E

    ffect

    Pain

    : Evi

    denc

    ePa

    in: S

    OE

    Func

    tion:

    M

    agni

    tude

    of E

    ffect

    Func

    tion:

    Ev

    iden

    ceFu

    nctio

    n:

    SOE

    NS

    AID

    sS

    mal

    l1

    SR

    (2 R

    CTs

    )Lo

    w--

    ----

    Ben

    zodi

    azep

    ines

    : dia

    zepa

    mR

    R, 0

    .5 (9

    5% C

    I, 0.

    3 to

    0.8

    )1

    RC

    TLo

    wN

    o ef

    fect

    1 R

    CT

    Low

    Sys

    tem

    ic c

    ortic

    oste

    roid

    sN

    o ef

    fect

    5 R

    CTs

    Mod

    erat

    eN

    o ef

    fect

    5 R

    CTs

    Mod

    erat

    eG

    abap

    entin

    /pre

    gaba

    linU

    nabl

    e to

    est

    imat

    e5

    RC

    TsIn

    suffi

    cien

    tU

    nabl

    e to

    est

    imat

    e5

    RC

    TsIn

    suffi

    cien

    tC

    I =

    con

    fide

    nce

    inte

    rval

    ; NS

    AID

    = n

    onst

    eroi

    dal a

    nti-

    infl

    amm

    ator

    y dr

    ug; R

    CT

    = r

    ando

    miz

    ed c

    ontr

    olle

    d tr

    ial;

    RR

    = r

    elat

    ive

    risk

    ; SO

    E =

    str

    engt

    h of

    evi

    denc

    e; S

    R =

    sys

    tem

    atic

    re

    view

    .

    Tabl

    e F.

    Non

    phar

    mac

    olog

    ical

    trea

    tmen

    ts v

    ersu

    s sh

    am, n

    o tr

    eatm

    ent,

    or u

    sual

    car

    e fo

    r acu

    te o

    r sub

    acut

    e lo

    w b

    ack

    pain

    Inte

    rven

    tion

    Pain

    : M

    agni

    tude

    of E

    ffect

    Pain

    : Evi

    denc

    ePa

    in: S

    OE

    Func

    tion:

    M

    agni

    tude

    of E

    ffect

    Func

    tion:

    Ev

    iden

    ceFu

    nctio

    n:

    SOE

    Exe

    rcis

    e vs

    . usu

    al c

    are

    Mod

    erat

    e1

    SR

    (3 R

    CTs

    ) + 3

    R

    CTs

    Low

    Mod

    erat

    e1

    SR

    (3 R

    CTs

    ) +

    3 R

    CTs

    Low

    Acu

    punc

    ture

    vs.

    sha

    mS

    mal

    l2

    RC

    TsLo

    wN

    o ef

    fect

    5 R

    CTs

    Low

    Mas

    sage

    vs.

    sha

    mM

    oder

    ate

    1 S

    R (2

    RC

    Ts)

    Low

    Mod

    erat

    e1

    SR

    (2 R

    CTs

    )Lo

    wM

    assa

    ge v

    s. u

    sual

    car

    eS

    mal

    l to

    no e

    ffect

    2 R

    CTs

    Low

    Sm

    all t

    o no

    effe

    ct2

    RC

    TsLo

    wS

    pina

    l man

    ipul

    atio

    n vs

    . sha

    mS

    mal

    l2

    RC

    TsLo

    wN

    o ef

    fect

    1 S

    R (3

    RC

    Ts)

    Low

    Hea

    t wra

    p vs

    . pla

    cebo

    Mod

    erat

    e1

    SR

    (2 R

    CTs

    ) + 2

    R

    CTs

    Mod

    erat

    eM

    oder

    ate

    1 S

    R (2

    RC

    Ts)

    Mod

    erat

    e

    Low

    -leve

    l las

    er th

    erap

    y pl

    us N

    SA

    ID v

    s.

    sham

    plu

    s N

    SA

    IDM

    oder

    ate

    1 R

    CT

    Low

    Sm

    all

    1 R

    CT

    Low

    Lum

    bar s

    uppo

    rts v

    s. n

    o lu

    mba

    r sup

    ports

    or

    inac

    tive

    treat

    men

    tU

    nabl

    e to

    det

    erm

    ine

    5 R

    CTs

    Insu

    ffici

    ent

    Una

    ble

    to d

    eter

    min

    e5

    RC

    TsIn

    suffi

    cien

    t

    NS

    AID

    = n

    onst

    eroi

    dal a

    nti-

    infl

    amm

    ator

    y dr

    ug; R

    CT

    = r

    ando

    miz

    ed c

    ontr

    olle

    d tr

    ial;

    SO

    E =

    str

    engt

    h of

    evi

    denc

    e; S

    R =

    sys

    tem

    atic

    rev

    iew

    .

  • ES-12

    Tabl

    e G

    . Non

    phar

    mac

    olog

    ical

    trea

    tmen

    ts v

    ersu

    s sh

    am, n

    o tr

    eatm

    ent,

    or u

    sual

    car

    e fo

    r chr

    onic

    low

    bac

    k pa

    in

    Inte

    rven

    tion

    Pain

    : Mag

    nitu

    de o

    f Ef

    fect

    Pain

    : Evi

    denc

    ePa

    in: S

    OE

    Func

    tion:

    M

    agni

    tude

    of E

    ffect

    Func

    tion:

    Ev

    iden

    ceFu

    nctio

    n:

    SOE

    Exe

    rcis

    e vs

    . usu

    al c

    are

    Sm

    all

    1 S

    R (1

    9 R

    CTs

    ) +

    1 S

    RM

    oder

    ate

    Sm

    all

    1 S

    R (1

    7 R

    CTs

    ) +

    1 S

    RM

    oder

    ate

    Mot

    or c

    ontro

    l exe

    rcis

    es v

    s. m

    inim

    al

    inte

    rven

    tion

    Mod

    erat

    e (s

    hort

    to

    long

    term

    )1

    SR

    (2 R

    CTs

    )Lo

    wS

    mal

    l (sh

    ort t

    o lo

    ng

    term

    )1

    SR

    (3 R

    CTs

    )Lo

    w

    Tai c

    hi v

    s. w

    ait l

    ist o

    r no

    tai c

    hiM

    oder

    ate

    2 R

    CTs

    Low

    Sm

    all

    1 R

    CT

    Low

    Yoga

    vs.

    usu

    al c

    are

    Mod

    erat

    e1

    RC

    TLo

    wM

    oder

    ate

    1 R

    CT

    Low

    Yoga

    vs.

    edu

    catio

    nS

    mal

    l (sh

    ort t

    erm

    ) an

    d no

    effe

    ct (l

    ong

    term

    )

    5 R

    CTs

    (sho

    rt te

    rm) +

    4 R

    CTs

    (lo

    ng te

    rm)

    Low

    Sm

    all (

    shor

    t ter

    m)

    and

    no e

    ffect

    (lon

    g te

    rm)

    5 R

    CTs

    (sho

    rt te

    rm) +

    4 R

    CTs

    (lo

    ng te

    rm)

    Low

    Pro

    gres

    sive

    rela

    xatio

    n vs

    . wai

    t-lis

    t con

    trol

    Mod

    erat

    e1

    SR

    (3 R

    CTs

    )Lo

    wM

    oder

    ate

    1 S

    R (3

    RC

    Ts)

    Low

    EM

    G b

    iofe

    edba

    ck v

    s. w

    ait l

    ist o

    r pla

    cebo

    Mod

    erat

    e1

    SR

    (3 R

    CTs

    )Lo

    wN

    o ef

    fect

    1 S

    R (3

    RC

    Ts)

    Low

    Ope

    rant

    ther

    apy

    vs. w

    ait-l

    ist c

    ontro

    lS

    mal

    l1

    SR

    (3 R

    CTs

    )Lo

    wN

    o ef

    fect

    1 S

    R (2

    RC

    Ts)

    Low

    Cog

    nitiv

    e-be

    havi

    oral

    ther

    apy

    vs. w

    ait-l

    ist

    cont

    rol

    Mod

    erat

    e1

    SR

    (5 R

    CTs

    )Lo

    wN

    o ef

    fect

    1 S

    R (4

    RC

    Ts)

    Low

    Mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    vs. n

    o m

    ultid

    isci

    plin

    ary

    reha

    bilit

    atio

    nM

    oder

    ate

    1 S

    R (3

    RC

    Ts)

    Low

    Sm

    all

    1 S

    R (3

    RC

    Ts)

    Low

    Mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    vs. u

    sual

    ca

    reM

    oder

    ate

    (sho

    rt te

    rm),

    smal

    l (lo

    ng

    term

    ), fa

    vors

    re

    habi

    litat

    ion

    1 S

    R (9

    RC

    Ts)

    (sho

    rt te

    rm) +

    1

    SR

    (7 R

    CTs

    ) (lo

    ng

    term

    )

    Mod

    erat

    eS

    mal

    l (sh

    ort a

    nd

    long

    term

    )1

    SR

    (9 R

    CTs

    ) (s

    hort

    term

    ) +

    1 S

    R (7

    RC

    Ts)

    (long

    term

    )

    Mod

    erat

    e

    Acu

    punc

    ture

    vs.

    sha

    m a

    cupu

    nctu

    reM

    oder

    ate

    1 S

    R (4

    RC

    Ts) +

    4

    RC

    TsLo

    wN

    o ef

    fect

    1 S

    R (4

    RC

    Ts) +

    4

    RC

    TsLo

    w

    Acu

    punc

    ture

    vs.

    no

    acup

    unct

    ure

    Mod

    erat

    e1

    SR

    (4 R

    CTs

    )M

    oder

    ate

    Mod

    erat

    e1

    SR

    (3 R

    CTs

    )M

    oder

    ate

    Spi

    nal m

    anip

    ulat

    ion

    vs. s

    ham

    man

    ipul

    atio

    nN

    o ef

    fect

    1 S

    R (3

    RC

    Ts) +

    1

    RC

    TLo

    wU

    nabl

    e to

    est

    imat

    e1

    RC

    T--

    Spi

    nal m

    anip

    ulat

    ion

    vs. i

    nert

    treat

    men

    tS

    mal

    l7

    RC

    TsLo

    w--

    ----

    Mas

    sage

    vs.

    usu

    al c

    are

    No

    effe

    ct1

    RC

    TLo

    wU

    nabl

    e to

    est

    imat

    e2

    RC

    TsIn

    suffi

    cien

    tU

    ltras

    ound

    vs.

    sha

    m u

    ltras

    ound

    No

    effe

    ct1

    SR

    (3 R

    CTs

    )Lo

    wU

    nabl

    e to

    est

    imat

    e5

    RC

    TsIn

    suffi

    cien

    tU

    ltras

    ound

    vs.

    no

    ultra

    soun

    dN

    o ef

    fect

    1 S

    R (2

    RC

    Ts)

    Low

    No

    effe

    ct1

    SR

    (2 R

    CTs

    )Lo

    wTE

    NS

    vs.

    sha

    m T

    EN

    SN

    o ef

    fect

    1 S

    R (4

    RC

    Ts)

    Low

    No

    effe

    ct1

    SR

    (2 R

    CTs

    )Lo

    wP

    EN

    S v

    s. s

    ham

    PE

    NS

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

  • ES-13

    Ele

    ctric

    al m

    uscl

    e st

    imul

    atio

    n vs

    . sha

    m, n

    o st

    imul

    atio

    n, o

    r usu

    al c

    are

    No

    evid

    ence

    ----

    No

    evid

    ence

    ----

    Low

    -leve

    l las

    er th

    erap

    y vs

    . sha

    m la

    ser

    Sm

    all

    3 R

    CTs

    Low

    Sm

    all

    3 R

    CTs

    Low

    Lum

    bar s

    uppo

    rts v

    s. n

    o lu

    mba

    r sup

    ports

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

    Una

    ble

    to e

    stim

    ate

    2 R

    CTs

    Insu

    ffici

    ent

    Trac

    tion

    vs. p

    lace

    bo, s

    ham

    , or n

    o tra

    ctio

    nU

    nabl

    e to

    est

    imat

    e1

    SR

    (13

    RC

    Ts)

    Insu

    ffici

    ent

    Una

    ble

    to e

    stim

    ate

    1 S

    R (1

    3 R

    CTs

    )In

    suffi

    cien

    tK

    ines

    io ta

    ping

    ® v

    s. s

    ham

    tapi

    ngN

    o ef

    fect

    2 R

    CTs

    Low

    No

    effe

    cts

    2 R

    CTs

    Low

    EM

    G =

    ele

    ctro

    myo

    grap

    hy; P

    EN

    S =

    per

    cuta

    neou

    s el

    ectr

    ical

    ner

    ve s

    tim

    ulat

    ion;

    RC

    T =

    ran

    dom

    ized

    con

    trol

    led

    tria

    l; S

    OE

    = s

    tren

    gth

    of e

    vide

    nce;

    SR

    =

    syst

    emat

    ic r

    evie

    w; T

    EN

    S =

    tran

    scut

    aneo

    us e

    lect

    rica

    l ner

    ve s

    tim

    ulat

    ion.

    Tabl

    e H

    . Non

    phar

    mac

    olog

    ical

    trea

    tmen

    ts v

    ersu

    s ac

    tive

    com

    para

    tors

    for c

    hron

    ic lo

    w b

    ack

    pain

    Inte

    rven

    tion

    Pain

    : Mag

    nitu

    de o

    f Ef

    fect

    Pain

    : Evi

    denc

    ePa

    in: S

    OE

    Func

    tion:

    M

    agni

    tude

    of E

    ffect

    Func

    tion:

    Ev

    iden

    ceFu

    nctio

    n:

    SOE

    MC

    E v

    s. g

    ener

    al e

    xerc

    ise

    (sho

    rt te

    rm)

    Sm

    all,

    favo

    rs M

    CE

    for

    shor

    t ter

    m1

    SR

    (6 R

    CTs

    )Lo

    wS

    mal

    l, fa

    vors

    MC

    E1

    SR

    (6 R

    CTs

    )Lo

    w

    MC

    E v

    s. g

    ener

    al e

    xerc

    ise

    (inte

    rmed

    iate

    term

    )S

    mal

    l, fa

    vors

    MC

    E fo

    r in

    term

    edia

    te te

    rm1

    SR

    (3 R

    CTs

    )Lo

    w--

    ----

    MC

    E v

    s. g

    ener

    al e

    xerc

    ise

    (long

    te

    rm)

    Sm

    all,

    favo

    rs M

    CE

    for

    long

    term

    1 S

    R (4

    RC

    Ts)

    Low

    Sm

    all,

    favo

    rs M

    CE

    1 S

    R (3

    RC

    Ts)

    Low

    MC

    E v

    s. m

    ultim

    odal

    phy

    sica

    l th

    erap

    y (in

    term

    edia

    te te

    rm)

    Mod

    erat

    e, fa

    vors

    MC

    E1

    SR

    (4 R

    CTs

    )Lo

    wM

    oder

    ate,

    favo

    rs

    MC

    E1

    SR

    (3 R

    CTs

    )Lo

    w

    MC

    E +

    exe

    rcis

    e vs

    . exe

    rcis

    e al

    one

    No

    clea

    r diff

    eren

    ce2

    RC

    TsLo

    w--

    ----

    Pila

    tes

    vs. u

    sual

    car

    e +

    phys

    ical

    ac

    tivity

    No

    effe

    ct to

    sm

    all

    effe

    ct, f

    avor

    s P

    ilate

    s7

    RC

    TsLo

    wN

    o cl

    ear d

    iffer

    ence

    7 R

    CTs

    Low

    Pila

    tes

    vs. o

    ther

    exe

    rcis

    eN

    o cl

    ear d

    iffer

    ence

    3 R

    CTs

    Low

    No

    clea

    r diff

    eren

    ce3

    RC

    TsLo

    wTa

    i chi

    vs.

    oth

    er e

    xerc

    ise

    Mod

    erat

    e, fa

    vors

    tai

    chi

    1 R

    CT

    Low

    ----

    --

    Yoga

    vs.

    exe

    rcis

    eS

    mal

    l, fa

    vors

    yog

    a1

    SR

    (5 R

    CTs

    )Lo

    w--

    ----

    Psy

    chol

    ogic

    al th

    erap

    ies

    vs.

    exer

    cise

    or p

    hysi

    cal t

    hera

    pyN

    o cl

    ear d

    iffer

    ence

    1 S

    R (6

    RC

    Ts)

    Low

    ----

    --

    Psy

    chol

    ogic

    al th

    erap

    ies

    vs.

    psyc

    holo

    gica

    l the

    rapi

    esN

    o cl

    ear d

    iffer

    ence

    10 R

    CTs

    Mod

    erat

    eN

    o cl

    ear d

    iffer

    ence

    10 R

    CTs

    Mod

    erat

    e

    Mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    vs.

    phys

    ical

    ther

    apy

    (sho

    rt te

    rm)

    Sm

    all,

    favo

    rs

    mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    1 S

    R (1

    2 R

    CTs

    )M

    oder

    ate

    Sm

    all,

    favo

    rs

    mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    1 S

    R (1

    3 R

    CTs

    )M

    oder

    ate

  • ES-14

    Mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    vs.

    phys

    ical

    ther

    apy

    (long

    term

    )M

    oder

    ate,

    favo

    rs

    mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    1 S

    R (9

    RC

    Ts)

    Mod

    erat

    eM

    oder

    ate,

    favo

    rs

    mul

    tidis

    cipl

    inar

    y re

    habi

    litat

    ion

    1 S

    R (1

    0 R

    CTs

    )M

    oder

    ate

    Spi

    nal m

    anip

    ulat

    ion

    vs. o

    ther

    act

    ive

    inte

    rven

    tions

    (exe

    rcis

    e, u

    sual

    car

    e,

    med

    icat

    ions

    , mas

    sage

    )

    No

    clea

    r diff

    eren

    ce1

    SR

    (6 R

    CTs

    )M

    oder

    ate

    No

    clea

    r diff

    eren

    ce1

    SR

    (6 R

    CTs

    )M

    oder

    ate

    Acu

    punc

    ture

    vs.

    med

    icat

    ions

    Sm

    all,

    favo

    rs

    acup

    unct

    ure

    1 S

    R (3

    RC

    Ts)

    Low

    Sm

    all,

    favo

    rs

    acup

    unct

    ure

    1 S

    R (3

    RC

    Ts)

    Low

    MC

    E =

    mot

    or c

    ontr

    ol e

    xerc

    ise;

    RC

    T =

    ran

    dom

    ized

    con

    trol

    led

    tria

    l; S

    OE

    = s

    tren

    gth

    of e

    vide

    nce;

    SR

    = s

    yste

    mat

    ic r

    evie

    w.

  • ES-15

    Discussion

    Key Findings and Strength of EvidenceThe key findings of this review are described in the summary-of-evidence table (Table I).

  • ES-16

    Tabl

    e I.

    Sum

    mar

    y of

    evi

    denc

    e

    Key

    Que

    stio

    nIn

    terv

    entio

    nO

    utco

    me

    Stre

    ngth

    of

    Evi

    denc

    eC

    oncl

    usio

    nK

    ey Q

    uest

    ion

    1.

    Pha

    rmac

    olog

    ical

    th

    erap

    ies

    Ace

    tam

    inop

    hen

    Ace

    tam

    inop

    hen

    vs.

    plac

    ebo,

    acu

    te L

    BP

    : Pai

    n an

    d fu

    nctio

    n

    Low

    One

    goo

    d-qu

    ality

    tria

    l fou

    nd n

    o di

    ffere

    nce

    betw

    een

    acet

    amin

    ophe

    n vs

    . pla

    cebo

    in p

    ain

    inte

    nsity

    or f

    unct

    ion

    thro

    ugh

    3 w

    eeks

    .

    Ace

    tam

    inop

    hen

    vs. N

    SA

    ID,

    acut

    e LB

    P: P

    ain

    and

    glob

    al

    impr

    ovem

    ent

    Insu

    ffici

    ent

    A sy

    stem

    atic

    revi

    ew fo

    und

    no d

    iffer

    ence

    bet

    wee

    n ac

    etam

    inop

    hen

    vs.

    NS

    AID

    s in

    pai

    n in

    tens

    ity (3

    tria

    ls; p

    oole

    d S

    MD

    , 0.2

    1; 9

    5% C

    I, −0

    .02

    to 0

    .43)

    or l

    ikel

    ihoo

    d of

    exp

    erie

    ncin

    g gl

    obal

    impr

    ovem

    ent (

    3 tri

    als;

    R

    R, 0

    .81;

    95%

    CI,

    0.58

    to 1

    .14)

    at ≤

    3 w

    eeks

    , alth

    ough

    est

    imat

    es

    favo

    red

    NS

    AID

    s.A

    ceta

    min

    ophe

    n vs

    . pla

    cebo

    , ch

    roni

    c LB

    PIn

    suffi

    cien

    tN

    o st

    udy

    eval

    uate

    d ac

    etam

    inop

    hen

    vs. p

    lace

    bo.

    Ace

    tam

    inop

    hen

    vs. N

    SA

    ID,

    chro

    nic

    LBP

    Insu

    ffici

    ent

    Ther

    e w

    as in

    suffi

    cien

    t evi

    denc

    e fro

    m 1

    tria

    l to

    dete

    rmin

    e ef

    fect

    s of

    ac

    etam

    inop

    hen

    vs. N

    SA

    IDs.

    Ace

    tam

    inop

    hen

    vs. o

    ther

    in

    terv

    entio

    ns, a

    cute

    LB

    PIn

    suffi

    cien

    tTh

    ere

    was

    insu

    ffici

    ent e

    vide

    nce

    from

    4 tr

    ials

    to d

    eter

    min

    e ef

    fect

    s of

    ac

    etam

    inop

    hen

    vs. o

    ther

    inte

    rven

    tions

    .A

    ceta

    min

    ophe

    n vs

    . pla

    cebo

    : A

    dver

    se e

    vent

    s (s

    erio

    us

    adve

    rse

    even

    ts)

    Mod

    erat

    eO

    ne tr

    ial f

    ound

    no

    diffe

    renc

    e be

    twee

    n sc

    hedu

    led

    acet

    amin

    ophe

    n, a

    s-ne

    eded

    ace

    tam

    inop

    hen,

    or p

    lace

    bo in

    risk

    of s

    erio

    us a

    dver

    se e

    vent

    s (~

    1% in

    eac

    h gr

    oup)

    .A

    ceta

    min

    ophe

    n vs

    . N

    SA

    IDs:

    Adv

    erse

    eve

    nts

    Mod

    erat

    eA

    syst

    emat

    ic re

    view

    foun

    d th

    at a

    ceta

    min

    ophe

    n w

    as a

    ssoc

    iate

    d w

    ith

    low

    er ri

    sk o

    f sid

    e ef

    fect

    s vs

    . NS

    AID

    s.A

    ceta

    min

    ophe

    n vs

    pl

    aceb

    o, N

    SA

    ID, o

    r oth

    er

    inte

    rven

    tion,

    radi

    cula

    r LB

    P

    Insu

    ffici

    ent

    No

    stud

    y ev

    alua

    ted

    acet

    amin

    ophe

    n fo

    r rad

    icul

    ar lo

    w b

    ack

    pain

    .

  • ES-17

    Key

    Que

    stio

    n 1.

    P

    harm

    acol

    ogic

    al

    ther

    apie

    s

    NS

    AID

    sN

    SA

    IDs

    vs. p

    lace

    bo, a

    cute

    LB

    P: P

    ain

    and

    func

    tion

    Mod

    erat

    e fo

    r pa

    in, l

    ow fo

    r fu

    nctio

    n

    A sy

    stem

    atic

    revi

    ew fo

    und

    NS

    AID

    s to

    be

    asso

    ciat