© American Academy of Pain Medicine 1526-2375/02/$15.00/361 361–365

CASE REPORTS

PAIN MEDICINE

Volume 3

•

Number 4

•

2002

Use of Lidocaine Patch 5% for Chronic Low Back Pain: A Report of Four Cases

Robert Hines, MD, Diane Keaney, RN, BSN, Michael H. Moskowitz, MD, and Steven Prakken, MD

A B S T R A C T

Bay Area Pain Medical Associates, Mill Valley, California

Objective.

To describe the use of the lidocaine patch 5% (Lidoderm

), a targeted peripheral analgesic,in treatment of patients with chronic low back pain.

Design.

This retrospective case series examines four patients with pain secondary to spinal degenera-tion and complications from failed back surgery syndrome, who were prescribed the lidocaine patchas an add-on to their analgesic regimen.

Setting.

Bay Area Pain Medical Associates, Mill Valley, California.

Patients.

Patients (age range: 33–64 years) were all complicated cases in which multiple analgesics hadbeen prescribed with varying degrees of success.

Intervention.

Lidocaine patch 5%.

Results.

The addition of the lidocaine patch helped relieve varying characteristics of pain, including gen-eral pain, shooting pain, burning pain, and allodynia, and had a significant impact on the quality oflife of all patients. Some patients were able to reduce or altogether stop some medications. No ad-verse events were reported from the lidocaine patch.

Conclusions.

Based on our experience with the four cases presented here and with other patients in ourclinic, we believe that addition of the lidocaine patch 5% to the analgesic regimen in chronic low back pain

may be beneficial. Prospective, controlled clinical trials are planned to further evaluate the efficacy and safetyof the lidocaine patch for treatment of chronic low back pain with or without a neuropathic component.

Key Words.

Lidocaine Patch; Neuropathic Pain; Chronic Pain; Low Back Pain; Targeted Peripheral Anal-gesic

Introduction

Chronic low back pain (LBP) is a common condi-tion. It has been estimated that 31 million people inthe United States experience chronic LBP [1], andthe burden of this disability has risen steadily overthe last few decades in western countries [2]. Back

injury may lead to complicated pain syndromes thatare difficult to treat and may not respond to even awide range of currently used therapies, includingnonsteroidal anti-inflammatory drugs (NSAIDs),muscle relaxants, opioid analgesics, tricyclic antide-pressants, injection therapies (nerve blocks, epidu-ral injections), electrical stimulation, and implantedintrathecal infusion pumps [3–7]. Although effec-tive in some cases, surgery may fail to relieve ormay even worsen pain in as many as 50% of pa-tients [8]. The primary pain mechanism in many

Reprint requests to:

Robert Hines, MD, Bay Area Pain Medi-cal Associates, 311 Miller Avenue, Suite B, Mill Valley, CA94941. Tel: (415) 380-0480; Fax: (415) 380-8788; E-mail:dmkeaney@bayareapainmedical.com.

362

Hines et al.

patients with chronic LBP is mechanical/myofas-cial without any neuropathic component [9], butneuropathic pain may also be a significant factor.Its presence may complicate therapy and increasethe risk of treatment failure.

The lidocaine patch 5% (Lidoderm

, EndoPharmaceuticals Inc., Chadds Ford, PA), a targetedperipheral analgesic, has been shown to be effectivefor the treatment of neuropathic pain and is cur-rently indicated for the management of patientswith postherpetic neuralgia (PHN) [10–12]. Theefficacy of the lidocaine patch established in PHN,combined with its low side-effect profile, has ledclinicians to prescribe this treatment modality forother pain states. Recent case reports have docu-mented successful pain reduction in neuropathic, aswell as in myofascial, pain states [13].

This case series reviews results from four pa-tients with refractory chronic LBP, with and with-out a neuropathic component, whose pain was suc-cessfully treated by the addition of the lidocainepatch to their analgesic therapy.

Case Reports

Patient 1

A 53-year-old woman with LBP pain presented inDecember 2000. She had been in pain since an au-tomobile accident that occurred in July 2000. In ad-dition to LBP, the patient developed urinary ur-gency, which limited her ability to work. Her backsymptoms included sharp pain from mid back to hip,rated as 8–9/10 (using a 0- to 10-point analog nu-meric pain scale), which kept her awake at night.She also experienced pain in the right leg and somenumbness in the right foot. Besides the presence ofneuropathic pain, clinical evaluation established noci-ceptive pain in the back as her primary condition.Magnetic resonance imaging showed lumbar spinedegeneration and a bulging disc, but no frank herni-ation. Physical examination indicated no neurologicdeficits. The patient’s medical history included priorback injury in 1993, rotator cuff injury, and hyper-tension. She was intolerant of both hydrocodone/acetaminophen (due to increased anxiety) and NSAIDs(edema), so treatment was initiated with tramadol(50 mg up to four times a day). The patient was alsotaking antihypertensive medication (sustained-releasediltiazem 120 mg bid), hormone replacement therapy(conjugate estrogen 0.625 mg qd), and medicationfor overactive bladder (triamterene 100 mg bid).Evaluation at 6 weeks after the initiation of tramadolindicated only a slight improvement in her symp-toms. She could sit or stand for no more than 3

hours and continued to have pain in her lower backand right hip. At that time, tramadol dosing wasdoubled to 50 mg up to eight times/day and thelidocaine patch (one on the right lower back and oneon the right leg) was also added to the treatment reg-imen. The patient also began wearing a brace. Sheindicated that treatment with the lidocaine patch“helped about 80%” and has reported no adverse ef-fects associated with its use. Subsequently, the tram-adol dosage was reduced by half. The patient didhave one episode of allodynia, in a band from thelower costal margin to the hips with duration of 1week, but this has not recurred. She has continuedthis successful daily treatment regimen, with the ad-dition of amitriptyline (10 mg qhs) to assist withsleep, up to the present time.

Patient 2

A 30-year-old woman suffered a lifting and twistinginjury in February 1996. In April 1999, the patientpresented with chronic neck, back, and leg pain, and amedical history including lumbar spinal fusion. Shewas being treated for pain and complications (depres-sion and sleep disturbance) with sertraline (300 mg qd,for anxiety), diazepam (5 mg prn, for sleep), rofecoxib(25 mg prn), and oxycodone controlled-release tablets(80 mg tid) and was also receiving progesterone ther-apy. While on this treatment regimen in January 2001,the patient complained of pain with neuropathic char-acteristics (including burning, stabbing pain in thelower back and right leg, with associated dysethesiasand allodynia). The lidocaine patch (two patches, 12hours on/12 hours off, applied to the affected areas)was then added to her treatment regimen. After 1month on the lidocaine patch, the patient was signifi-cantly more active and was able to return to work. Herpain was reduced by three points on the analog nu-meric pain scale from 8 to 5/10. She had occasionalshooting pain in her buttocks, and this pain was effec-tively treated with the lidocaine patch. The patient iscontinuing treatment with one lidocaine patch daily inaddition to the aforementioned treatment regimen,with good efficacy and no adverse events.

Patient 3

A 64-year-old man presented in September 2000with a cold and discolored left foot, together withnumbness and allodynia. The patient also had painin both the left lower leg and foot. The pain wasrated as 4/10 in the morning and increased to 8/10with activity. The patient had a long history ofLBP, beginning in 1987 with a lifting injury. Hismedical history included spinal anterior interbody

Lidocaine Patch 5% for Chronic Low Back Pain

363

arthrodesis at L4–L5 in 1998, which resolved hisLBP at that time. The pain recurred and wastreated with sympathetic blockade in May 2000.The initial injections improved the lower extremitysymptoms by 30%, but another block 2 monthslater produced only 10% improvement. The pa-tient had no other relevant medical history. His di-agnosis was lumbar degenerative disc disease, L4–L5arthrodesis, and complex regional pain syndrometype 2 in the left lower extremity.

The patient was initially treated with gabapentin(300 mg qd), atenolol (25 mg qd, for managementof mild ectopy), and ibuprofen (600 mg qd). Thiscombination of drugs did not control his symp-toms. He was intolerant of opioid analgesics due tosevere constipation, whereas previous treatment withclonidine (0.1 mg bid) had been ineffective. In No-vember 2000, the patient began treatment with thelidocaine patch (two to three patches, 12 hours on/12 hours off, placed on foot and leg), tizanidine (4 mgevery 8 hours), and verapamil (120 mg qd, for themanagement of supraventricular tachycardia). Thisregimen resulted in a 75% improvement in painsymptoms, and the patient was described as satis-fied with his pain control; the regimen also helpedto reduce swelling. The patient’s status continuedto improve through February 2001, when vera-pamil was discontinued due to itchy skin; the num-ber of lidocaine patches was reduced to one perday, but was increased again to two per day in April2001. In July 2001, he was able to discontinuetreatment with tizanidine. Treatment with thelidocaine patch and no other pharmacologic inter-vention continues to provide good results in thispatient and has not been associated with any ad-verse events. The patient’s LBP has remained re-solved and direct application of the lidocaine patchhas provided effective pain relief of his foot.

Patient 4

A 50-year-old woman with a 22-year history ofback pain presented in October 2000 with low rightback pain (aching and burning) that extended to herbuttocks and right leg. The patient also reportedmuscle spasms in her back, but denied hyperalgia orallodynia. Magnetic resonance imaging in 1999 hadindicated a herniated disc (L4–L5) and idiopathicand degenerative scoliosis. At the time of presenta-tion, the patient was being treated with citalopram(60 mg qd), olanzapine (5 mg qd), lorazepam (1 mgqd or bid), and cyclobenzaprine (10 mg prn). Shewas also receiving hormone replacement therapy.The patient had failed prior treatment with hydro-codone (due to constipation), fluoxetine (lack of ef-

ficacy), amitriptyline (sedation), venlafaxine (lack ofefficacy), and buspirone (lack of efficacy). In De-cember 2000, therapy was changed with the substi-tution of clonidine (3 mg qd) for lorazepam, the ad-dition of baclofen (20 mg tid), and another trial ofvenlafaxine (150 mg qd). At the end of 2000, thepatient complained of an area of burning pain andallodynia in her lower back, and the lidocaine patch(one patch, 12 hours on/12 hours off, placed overthe area of the allodynia) was added to her thera-peutic regimen. Gabapentin (300 mg tid) was alsoadded. Initially, the patient noted some short-termpain relief with the patch. Further evaluation inMarch 2001 indicated that her burning pain re-sponded well to the combination of the lidocainepatch and gabapentin. At present, she continuesthis therapeutic regimen with good efficacy and noadverse events.

Discussion

Chronic LBP is a complex and difficult-to-treatcondition that may often involve multiple painmechanisms, including neuropathic, myofascial, andchronic inflammatory elements [4,5,9,14]. Themost commonly prescribed medications for the al-leviation of LBP are NSAIDs, including cyclo-oxy-genase-2 inhibitors, muscle relaxants, and opioids.It is currently believed that NSAIDs, cyclo-oxygen-ase-2 inhibitors, and opioids may be beneficial ifnociceptive pain is present in patients with thiscondition. Muscle relaxants are actually sedative–hypnotic drugs that do not have direct activity onthe muscle and are thought by many pain authori-ties not to possess analgesic properties [15,16]. If aneuropathic component is believed to be present ina patient with LBP, then those drugs often pre-scribed for the treatment of neuropathic pain, e.g.,tricyclic antidepressants, anticonvulsants, and opi-oids, may be administered. Tricyclic antidepressantsmay have mechanisms related to the endogenouscentral nervous pain-modulating system or mayhave sodium-channel-blocking activity. Some anti-convulsants also possess a sodium-channel-antago-nistic mechanism, whereas others, such as gabapen-tin, have unknown analgesic mechanisms [17]. It isfrequently found that patients with chronic LBPhave little response to, or great difficulty in tolerat-ing, treatment with these analgesics [18,19].

A novel pharmacologic approach to treatingchronic pain—use of the lidocaine patch 5%—hasrecently gained favor among pain specialists due toits efficacy, once-daily dosing without necessary ti-tration, and lack of systemic side effects [10,20].

364

Hines et al.

Results from controlled clinical trials have demon-strated that the lidocaine patch is effective for thetreatment of neuropathic pain associated with PHN[10–12]. Recent clinical experience indicates thatthe lidocaine patch may also be effective for thetreatment of other neuropathic and non-neuro-pathic pain states [10,13,20]. Most recently, Dal-piaz et al. [13] showed that five of six patients withchronic myofascial pain syndrome treated for 28days with the lidocaine patch had a partial or com-plete response to therapy. In the treatment of neu-ropathic pain, e.g., PHN or neuropathic LBP, themechanism of action of the lidocaine patch is be-lieved to be related to the action of lidocaine on thesodium channels of dysfunctional nociceptors inthe dermal layers directly underlying the area ofpatch application [10]. In myofascial pain, however,the mechanism of action is less clear. It can be hy-pothesized that a similar mechanism of action is oc-curring, i.e., lidocaine binds to the sodium channelsof dysfunctional nociceptors that also may be ab-normally active in the muscles and soft tissues inchronic myofascial pain syndromes.

In patient 3, a multimodal treatment regimen,including the lidocaine patch, was shown to helpreduce swelling. A recent study demonstrated theimmunoregulatory effects of lidocaine on T cells inpatients with allergic asthma [21]. The lidocainepatch may, therefore, also possess anti-inflamma-tory actions.

In patient 4, the combination of the lidocainepatch and gabapentin was successful in managingburning pain and allodynia of the lower back. In re-gard to allodynia, there are four theoretical mecha-nisms to explain the possible beneficial effects ofthe lidocaine patch in this patient. First, blockadeof abnormally functioning sodium channels ondamaged peripheral nerves may decrease ectopicnociceptive pain signals transmitted to the dorsalhorn of the spinal cord. Second, the lidocaine patchmay act as a mechanical barrier to the area of allo-dynia, thus preventing stimulation [10]. A thirdpossible mechanism in both chronic nociceptiveand neuropathic allodynia involves disruption ofthe cycle of recruitment outside the zone of injuryby chronically stimulated nociceptors of non-noci-ceptor A–

�

–mechanoreceptors and touch receptors[22,23]. The fourth possibility is interruption of theproposed mechanism of antidromic neurogenic in-flammation. Efferent stimulation of injured nerves viaantidromic signals traveling back down afferent no-ciceptors is speculated to cause inflammation thatdoes not respond to NSAIDs or cyclo-oxygenase-2inhibitors. Release of histamines, substance P, and

calcitonin-gene-related peptide causes recruitmentof non-nociceptors. It is possible that the lidocainepatch interrupts this cycle [22–24].

In comparison with other drugs currently beingprescribed to treat LBP, the lidocaine patch hasseveral important clinical advantages in the man-agement of pain syndromes. Since the target of thedrug’s mechanism of action is restricted to theperipheral nerve and soft tissues, no significantplasma levels of lidocaine are produced, even with24-hour daily dosing (systemic absorption from thepatch is minimal—3%

�

2%) [10]. Thus, there areno significant pharmacokinetic or pharmacologicinteractions with other drugs [25]. Using the prin-ciple of first prescribing the least invasive and safesttreatment, the lidocaine patch represents an effec-tive first step in the management of pain conditionswhere a peripheral pain mechanism (neuropathic,myofascial, and/or chronic inflammatory) is thoughtto be operative, as in the case of LBP.

The four patients described in this case seriesdemonstrate that the use of the lidocaine patch 5%as part of a multimodal therapeutic approach canproduce positive results in the management of pa-tients with chronic LBP. Although three of the pa-tients had the lidocaine patch added as part of amultimodal intervention, patient 2 had the patchadded as the sole intervention. The use of a combi-nation of interventions is reflective of general clini-cal practice and, therefore, we recognize that thesuccessful pain relief observed in patients 1, 3, and4 cannot be solely attributed to the lidocaine patch.Further controlled trials are needed to fully exam-ine the effect of the lidocaine patch in LBP. Onesuch trial, in which the authors are participating in-vestigators, is ongoing [26].

Conclusions

The positive results obtained in the present case se-ries suggest that the lidocaine patch 5%, a targetedperipheral analgesic, is a novel, effective, well-tol-erated, and safe medical treatment for LBP. Pro-spective, controlled trials should be conducted tofurther evaluate the utility of the lidocaine patchfor the treatment of this condition.

Acknowledgments

Bay Area Pain Medical Associates received financial sup-port from Endo Pharmaceuticals Inc. for this case series.We would also like to express thanks to Adelphi Inc. forassistance with manuscript preparation.

Lidocaine Patch 5% for Chronic Low Back Pain

365

References

1 Rizzo JA, Abbott TA 3rd, Berger ML. The laborproductivity effects of chronic backache in theUnited States. Med Care 1998;36:1471–88.

2 Valat JP, Goupille P, Vedere V. Low back pain: riskfactors for chronicity. Rev Rheum Engl Ed 1997;64:189–94.

3 Slavin KV, Burchiel KJ, Anderson VC, et al. Effi-cacy of transverse tripolar stimulation for relief ofchronic low back pain: Results of a single center.Stereotact Funct Neurosurg 1999;73:126–30.

4 Braverman DL, Slipman CW, Lenrow DA. Usinggabapentin to treat failed back surgery syndromecaused by epidural fibrosis: A report of 2 cases. ArchPhys Med Rehabil 2001;82:691–3.

5 Deyo RA. Drug therapy for back pain. Which drugshelp which patients? Spine 1996;21:2840–50.

6 Borenstein DG. Epidemiology, etiology, diagnosticevaluation, and treatment of low back pain. CurrOpin Rheumatol 1999;11:151–7.

7 Grabow TS, Derdzinski D, Staats PS. Spinal drugdelivery. Curr Pain Headache Rep 2001;5:510–6.

8 Gill K, Blumenthal SL. Functional results after an-terior lumbar fusion at L5–S1 in patients with nor-mal and abnormal MRI scans. Spine 1992;17:940–2.

9 Pongratz D, Spath M. [What helps in back pain?Guideline for symptomatic therapy.] MMW FortschrMed 2001;143:26–9. German.

10 Argoff CE. New analgesics for neuropathic pain:The lidocaine patch. Clin J Pain 2000;16:S62–6.

11 Rowbotham MC, Davies PS, Verkempinck C, et al.Lidocaine patch: Double-blind controlled study ofa new treatment method for post-herpetic neural-gia. Pain 1996;65:39–44.

12 Galer BS, Rowbotham MC, Perander J, et al. Topicallidocaine patch relieves postherpetic neuralgia moreeffectively than a vehicle topical patch: Results of anenriched enrollment study. Pain 1999;80:533–8.

13 Dalpiaz AS, Lipman AG, Lordon SP. Initial effi-cacy trial of topical lidocaine patches in the man-agement of chronic myofascial pain. Presented at

the annual meeting of American Pain Society, At-lanta, GA, 2000.

14 Sorensen J, Aaro S, Bengtsson M, et al. Can a phar-macological pain analysis in patients with chroniclow back pain predict the outcome of lumbar fu-sion? Preliminary report. Eur Spine J 1996;5:326–31.

15 Aronoff GM, Dupuy DN. Evaluation and manage-ment of back pain: preventing disability. J BackMuskuloskeletal 1997;9:109–24.

16 Strumpf M, Linstedt U, Wiebalck A, et al. [Treat-ment of low back pain—significance, principles anddanger.] Schmerz 2001;15:453–60. German.

17 Attal N. Pharmacologic treatment of neuropathicpain. Acta Neurol Belg 2001;101:53–64.

18 Attal N. Chronic neuropathic pain: Mechanismsand treatment. Clin J Pain 2000;16:S118–30.

19 Watson CPN. The treatment of neuropathic pain:Antidepressants and opioids. Clin J Pain 2000;16:S49–55.

20 Devers A, Galer BS. Topical lidocaine patch re-lieves a variety of neuropathic pain conditions: Anopen-label study. Clin J Pain 2000;16:205–8.

21 Tanaka A, Minoguchi K, Oda N, et al. Inhibitoryeffect of lidocaine on T cells from patients with al-lergic asthma. J Allergy Clin Immunol 2002;109:485–90.

22 Devor M. Evaluation and treatment of chronic pain,third edition. Baltimore, MD: Williams and Wilkins;1998.

23 Raja SN, Meyer RA, Ringkamp MA, et al. Text-book of pain, fourth edition. London, UK: Churchill-Livingston; 1999.

24 Levine J, Taiwo Y. Textbook of pain, third edition.London, UK: Churchill-Livingston; 1994–1995.

25 Comer AM, Lamb HM. Lidocaine patch 5%.Drugs 2000;59:245–9.

26 Argoff C, Moskowitz M, Backonja M, et al. Effec-

tiveness of lidocaine patch 5% (Lidoderm

) in thetreatment of low back pain. Presented at the TenthWorld Congress on Pain, San Diego, CA, August17–22, 2002.