NORTRIPTYLINE VERSUS SUSTAINED-RELEASE MORPHINE VERSUS COMBINATION THERAPY IN CHRONIC LUMBAR RADICULOPATHY A RANDOMIZED CROSSOVER TRIAL
DOI:
https://doi.org/10.48047/hmn1m832Keywords:
Lumbar radiculopathy, Neuropathic pain, Nortriptyline, Opioid therapy, Randomized crossover trial.Abstract
diabetic neuropathy and postherpetic neuralgia, and little evidence is given on lumbar radiculopathy.
Purpose: To evaluate the analgesic efficacy of nortriptyline, sustained-release morphine, a combination of the two, and placebo on patients with chronic lumbar radicular pain.
Methods: A randomized, four-period, double-blind, crossover trial was done on 121 patients with chronic lumbar radiculopathy where sustained-release morphine, nortriptyline, combination therapy, and placebo were used. An outcome measure of average leg pain was the primary, and secondary measures were global pain, disability, mood, and quality of life.
Findings: Nortriptyline showed a significant reduction in average and worst pain score by a ratio of about 2533 percent over placebo without zero confidence intervals. Morphine had small, not significant pain reliefs. Combination therapy produced comparable analgesic effects to nortriptyline monotherapy, and an extra effect in mood and quality of life.
Conclusion: Nortriptyline and morphine alone or combined with morphine were better than morphine monotherapy and placebo in reduction of pain and functional results of chronic lumbar radiculopathy.
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References
Arner S, Meyerson BA. Lack of analgesic effect of opioids on neuropathic and idiopathic forms of pain. Pain. 1988;33(1):11–23. doi: 10.1016/0304-3959(88)90198-4.
Atkinson JH, Slater MA, Williams RA, Zisook S, Patterson TL, Grant I, Wahlgren DR, Abramson I, Garfin SR. A placebo-controlled randomized clinical trial of nortriptyline for chronic low back pain. Pain. 1998;76(3):287–296. doi: 10.1016/S0304-3959(98)00064-5.
Colton T. Statistics in Medicine. Boston: Little Brown; 1974.
Dellemijn PL, van Duijn H, Vanneste JA. Prolonged treatment with transdermal fentanyl in neuropathic pain. J Pain Symptom Manage. 1998;16(4):220–229. doi: 10.1016/s0885-3924(98)00070-0.
Dellemijn PL, Vanneste JA. Randomised double-blind active-placebo-controlled crossover trial of intravenous fentanyl in neuropathic pain. Lancet. 1997;349(9054):753–758. doi: 10.1016/S0140-6736(96)09024-1.
Dworkin RH, Backonja M, Rowbotham MC, Allen RR, Argoff CR, Bennett GJ, Bushnell MC, Farrar JT, Galer BS, Haythornthwaite JA, Hewitt DJ, Loeser JD, Max MB, Saltarelli M, Schmader KE, Stein C, Thompson D, Turk DC, Wallace MS, Watkins LR, Weinstein SM. Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. Arch Neurol. 2003a;60(11):1524–1534. doi: 10.1001/archneur.60.11.1524.
Dworkin RH, Corbin AE, Young JP, Jr, Sharma U, LaMoreaux L, Bockbrader H, Garofalo EA, Poole RM. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology. 2003b;60(8):1274–1283. doi: 10.1212/01.wnl.0000055433.55136.55.
Eisenberg E, McNicol ED, Carr DB. Efficacy and safety of opioid agonists in the treatment of neuropathic pain of nonmalignant origin: systematic review and meta-analysis of randomized controlled trials. Jama. 2005;293(24):3043–3052. doi: 10.1001/jama.293.24.3043.
Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271–273.
Fardon DF, Milette PC. Nomenclature and classification of lumbar disc pathology. Recommendations of the Combined task Forces of the North American Spine Society, American Society of Spine Radiology, and American Society of Neuroradiology. Spine. 2001;26(5):E93–E113. doi: 10.1097/00007632-200103010-00006.
Farrar JT, Young JP, Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158. doi: 10.1016/S0304-3959(01)00349-9.
Finnerup NB, Otto M, McQuay HJ, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain. 2005;118(3):289–305. doi: 10.1016/j.pain.2005.08.013.
Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF, Houlden RL. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med. 2005;352(13):1324–1334. doi: 10.1056/NEJMoa042580.
Gilron I, Max MB. Combination pharmacotherapy for neuropathic pain: current evidence and future directions. Expert Rev Neurother. 2005;5(6):823–830. doi: 10.1586/14737175.5.6.823.
Gimbel JS, Richards P, Portenoy RK. Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial. Neurology. 2003;60(6):927–934. doi: 10.1212/01.wnl.0000057720.36503.2c.
Heliovaara M, Knekt P, Aromaa A. Incidence and risk factors of herniated lumbar intervertebral disc or sciatica leading to hospitalization. J Chronic Dis. 1987;40(3):251–258. doi: 10.1016/0021-9681(87)90161-5.
Hills M, Armitage P. The two-period cross-over clinical trial. Br J Clin Pharmacol. 1979;8(1):7–20. doi: 10.1111/j.1365-2125.1979.tb05903.x.
Irvine EJ. Measurement and expression of risk: optimizing decision strategies. Am J Med. 2004;117(Suppl 5A):2S–7S. doi: 10.1016/j.amjmed.2004.07.029.
Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27(1):117–126. doi: 10.1016/0304-3959(86)90228-9.
Khoromi S, Patsalides A, Parada S, Salehi V, Meegan JM, Max MB. Topiramate in chronic lumbar radicular pain. J Pain. 2005;6(12):829–836. doi: 10.1016/j.jpain.2005.08.002.
Kishore-Kumar R, Max MB, Schafer SC, Gaughan AM, Smoller B, Gracely RH, Dubner R. Desipramine relieves postherpetic neuralgia. Clin Pharmacol Ther. 1990;47(3):305–312. doi: 10.1038/clpt.1990.33.
Kroenke K, Spitzer RL, deGruy FV, 3rd, Swindle R. A symptom checklist to screen for somatoform disorders in primary care. Psychosomatics. 1998;39(3):263–272. doi: 10.1016/S0033-3182(98)71343-X.
Lacroix-Fralish ML, Tawfik VL, Tanga FY, Spratt KF, DeLeo JA. Differential spinal cord gene expression in rodent models of radicular and neuropathic pain. Anesthesiology. 2006;104(6):1283–1292. doi: 10.1097/00000542-200606000-00025.
Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004;63(11):2104–2110. doi: 10.1212/01.wnl.0000145767.36287.a1.
Max MB, Lynch SA, Muir J, Shoaf SE, Smoller B, Dubner R. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med. 1992;326(19):1250–1256. doi: 10.1056/NEJM199205073261904.
Max MB, Schafer SC, Culnane M, Smoller B, Dubner R, Gracely RH. Amitriptyline, but not lorazepam, relieves postherpetic neuralgia. Neurology. 1988;38(9):1427–1432. doi: 10.1212/wnl.38.9.1427.
Milliken G, Johnson DE. Analysis of Messy Data. New York: Van Nostrand Reinhold Co; 1984.
Moulin DE, Iezzi A, Amireh R, Sharpe WK, Boyd D, Merskey H. Randomised trial of oral morphine for chronic non-cancer pain. Lancet. 1996;347(8995):143–147. doi: 10.1016/s0140-6736(96)90339-6.
Raja SN, Haythornthwaite JA, Pappagallo M, Clark MR, Travison TG, Sabeen S, Royall RM, Max MB. Opioids versus antidepressants in postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology. 2002;59(7):1015–1021. doi: 10.1212/wnl.59.7.1015.
Remmers AE, Sharma U, Lamoreaux L, Young JP, Moore J, Poole RM. Pregabalin treatment of patients with chronic low back pain. Proceedings of the 19th Annual Meeting of the American Pain Society 2000; Atlanta, Georgia. Abstract 660.
Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6(4):253–260. doi: 10.1016/j.jpain.2004.12.007.
Rowbotham MC, Reisner-Keller LA, Fields HL. Both intravenous lidocaine and morphine reduce the pain of postherpetic neuralgia. Neurology. 1991;41(7):1024–1028. doi: 10.1212/wnl.41.7.1024.
Rowbotham MC, Twilling L, Davies PS, Reisner L, Taylor K, Mohr D. Oral opioid therapy for chronic peripheral and central neuropathic pain. N Engl J Med. 2003;348(13):1223–1232. doi: 10.1056/NEJMoa021420.
Sang CN, Booher S, Gilron I, Parada S, Max MB. Dextromethorphan and memantine in painful diabetic neuropathy and postherpetic neuralgia: efficacy and dose-response trials. Anesthesiology. 2002;96(5):1053–1061. doi: 10.1097/00000542-200205000-00005.
Schnitzer TJ, Gray WL, Paster RZ, Kamin M. Efficacy of tramadol in treatment of chronic low back pain. J Rheumatol. 2000;27(3):772–778.
Sindrup SH, Bach FW, Madsen C, Gram LF, Jensen TS. Venlafaxine versus imipramine in painful polyneuropathy: a randomized, controlled trial. Neurology. 2003;60(8):1284–1289. doi: 10.1212/01.wnl.0000058749.49264.bd.
Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999;83(3):389–400. doi: 10.1016/S0304-3959(99)00154-2.
van Seventer R, Feister HA, Young JP, Jr, Stoker M, Versavel M, Rigaudy L. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin. 2006;22(2):375–384. doi: 10.1185/030079906x80404.
Ware JE., Jr SF-36 health survey update. Spine. 2000;25(24):3130–3139. doi: 10.1097/00007632-200012150-00008.
Watson CP, Babul N. Efficacy of oxycodone in neuropathic pain: a randomized trial in postherpetic neuralgia. Neurology. 1998;50(6):1837–1841. doi: 10.1212/wnl.50.6.1837.
Watson CP, Evans RJ, Reed K, Merskey H, Goldsmith L, Warsh J. Amitriptyline versus placebo in postherpetic neuralgia. Neurology. 1982;32(6):671–673. doi: 10.1212/wnl.32.6.671.
Watson CP, Moulin D, Watt-Watson J, Gordon A, Eisenhoffer J. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain. 2003;105(1–2):71–78. doi: 10.1016/s0304-3959(03)00160-x.
Watson CP, Vernich L, Chipman M, Reed K. Nortriptyline versus amitriptyline in postherpetic neuralgia: a randomized trial. Neurology. 1998;51(4):1166–1171. doi: 10.1212/wnl.51.4.1166.
Williams AC, Richardson PH. What does the BDI measure in chronic pain? Pain. 1993;55(2):259–266. doi: 10.1016/0304-3959(93)90155-I.
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee Arthritis Rheum. 1990;33(2):160–172. doi: 10.1002/art.1780330203.
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