The preliminary results of a comparative effectiveness evaluation of adhesiolysis and caudal epidural injections in managing chronic low back pain secondary to spinal stenosis: A randomized, equivalence controlled trial

Pain Physician

Volumn 12, Issue 6, 2009, Pages

  Manchikanti, Laxmaiah ^a,d   Cash, Kimberly A ^a   McManus, Carla D ^a   Pampati, Vidyasagar ^a   Singh, Vijay ^b   Benyamin, Ramsin ^c,e  

^a PAIN MANAGEMENT CENTER OF PADUCAH   (United States)

^b Pain Diagnostics Associates   (United States)

^c MILLENNIUM PAIN CENTER   (United States)

^d University of Louisville School of Medicine   (United States)

^e UNIVERSITY OF ILLINOIS   (United States)

Author keywords

Hypertonic sodium chloride solution; Local anesthetics; Percutaneous adhesiolysis; Pragmatic trial; Randomized equivalence controlled trial; Spinal stenosis; Steroids

Indexed keywords

BETAMETHASONE; HYPERTONIC SOLUTION; LIDOCAINE; OPIATE; SODIUM CHLORIDE;

ADHESION; ADULT; AGED; ANALGESIA; ARTICLE; CATHETERIZATION; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; EVALUATION RESEARCH; FEMALE; FLUOROSCOPY; HUMAN; LEG PAIN; LOW BACK PAIN; LUMBAR SPINAL CORD; MAJOR CLINICAL STUDY; MALE; NEUROLYSIS; OUTCOME ASSESSMENT; PERCUTANEOUS ADHESIOLYSIS; RANDOMIZED CONTROLLED TRIAL; VERTEBRAL CANAL STENOSIS;

AGED; ANESTHESIA, EPIDURAL; ANESTHETICS, LOCAL; CASE-CONTROL STUDIES; CHI-SQUARE DISTRIBUTION; CHRONIC DISEASE; DISABILITY EVALUATION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS, EPIDURAL; LIDOCAINE; LOW BACK PAIN; MALE; MIDDLE AGED; PAIN MEASUREMENT; SPINAL STENOSIS; STEROIDS; TIME FACTORS;

EID: 76549093869     PISSN: 15333159     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (85)

1. Cummins J, Lurie JD, Tosteson TD, Hanscom B, Abdu WA, Birkmeyer NJ, Herkowitz H, Weinstein J. Descriptive epidemiology and prior healthcare utilization of patients in the Spine Patient Outcomes Research Trial's (SPORT) three observational cohorts: Disc herniation, spinal stenosis, and degenerative spondylolisthesis. Spine (Phila Pa 1976) 2006; 31:806-814.
2. Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine (Phila Pa 1976) 1994; 19:1201-1206.
3. Katz JN, Harris MB. Clinical practice. Lumbar spinal stenosis. N Engl J Med 2008; 358:818-825.
4. Deyo RA, Ciol MA, Cherkin DC, Loeser JD, Bigos SJ. Lumbar spinal fusion: A cohort study of complications, reoperations, and resource use in the Medicare population. Spine (Phila Pa 1976) 1993; 18:1463-1470.
5. Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI. United States trends in lumbar fusion surgery for degenerative conditions. Spine (Phila Pa 1976) 2005; 30:1441-1445.
6. Ciol MA, Deyo RA, Howell E, Kreif S. An assessment of surgery for spinal stenosis: Time trends, geographic variations, complications, and reoperations. J Am Geriatr Soc 1996; 44:285-290.
7. Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med 2008; 358:794-810.
8. Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ. Spinal stenosis prevalence and association with symptoms: The Framingham Study. Spine J 2009; 9:545-550.
9. ECRI Health Technology Assessment Group. Treatment of degenerative lumbar spinal stenosis. Evid Rep Technol Assess (Summ) 2001; 32:1-5.
10. Boden SD, McCowin PR, Davis DO, Dina TS, Mark AS, Wiesel S. Abnormal magnetic resonance scans of the lumbar spine in asymptomatic subjects: A prospective investigation. J Bone Joint Surg Am 1990; 72:403-408.
11. Jensen MC, Brant-Zawadzki MN, Obuchowski N, Modic MT, Malkasian D, Ross JS. Magnetic resonance imaging of the lumbar spine in people without back pain. N Engl J Med 1994; 331:69-73.
12. Manchikanti L, Cash KA, McManus CD, Pampati V, Abdi S. Preliminary results of randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 4. Spinal stenosis. Pain Physician 2008; 11:833-848.
13. Manchikanti L, Giordano J. Physician payment 2008 for interventionalists: Current state of health care policy. Pain Physician 2007; 10:607-626.
14. Friedly J, Leighton C, Deyo R. Increases in lumbosacral injections in the Medicare population: 1994 to 2001. Spine (Phila Pa 1976) 2007; 32:1754-1760.
15. Manchikanti L, Singh V, Pampati V, Smith HS, Hirsch JA. Analysis of growth of interventional techniques in managing chronic pain in Medicare population: A 10-year evaluation from 1997 to 2006. Pain Physician 2009; 12:9-34.
16. Gibson JN, Waddell G. Surgery for degenerative lumbar spondylosis. Cochrane Database Syst Rev 2005; 4: CD001352.
17. Atlas SJ, Deyo RA, Keller RB, Chapin AM, Patrick DL, Long JM, Singer DE. The Maine Lumbar Spine Study, Part III: 1-year outcomes of surgical and nonsurgical management of lumbar spinal stenosis. Spine (Phila Pa 1976) 1996; 21:1787-1794.
18. Johnsson KE, Uden A, Rosen I. The effect of decompression on the natural course of spinal stenosis: A comparison of surgically treated and untreated patients. Spine (Phila Pa 1976) 1991; 16:615-619.
19. Malmivaara A, Statis P, Heliovaara M, Kankare J, Seitsalo S. Surgical treatment for moderate lumbar spinal stenosis: A randomized controlled trial. In: Proceedings of the International Society for Study of the Lumbar Spine, Porto, Portugal, May 30-June 5, 2004.
20. Mariconda M, Fava R, Gatto A, Longo C, Milano C. Unilateral laminectomy for bilateral decompression of lumbar spinal stenosis: A prospective comparative study with conservatively treated patients. J Spinal Disord Tech 2002; 15:39-46.
21. Gibson JNA, Waddell G, Grant IC. Surgery for degenerative lumbar spondylolysis. Cochrane Database Syst Rev 2000; 3:CD001352.
22. Airaksinen O, Herno A, Turunen V, Saari T, Suomlainen O. Surgical outcome of 438 patients treated surgically for lumbar spinal stenosis. Spine (Phila Pa 1976) 1997; 22:2278-2282.
23. Cornefjord M, Byröd G, Brisby H, Rydevik B. A long-term (4- to 12-year) follow-up study of surgical treatment of lumbar spinal stenosis. Eur Spine J 2000; 9:563-570.
24. Hansraj KK, Cammisa FP Jr, O'Leary PF, Crockett HC, Fras CI, Cohen MS, Dorey FJ. Decompressive surgery for typical lumbar spinal stenosis. Clin Orthop 2001; 384:10-17.
25. Katz JN, Lipson SJ, Chang LC, Levine SA, Fossel AH, Liang MH. Seven- to 10-year outcome of decompressive surgery for degenerative lumbar spinal stenosis. Spine (Phila Pa 1976) 1996; 21:92-98.
26. Kuntz KM, Snider RK, Weinstein JN, Pope MH, Katz JN. Cost-effectiveness of fusion with and without instrumentation for patients with degenerative spondylolisthesis and spinal stenosis. Spine (Phila Pa 1976) 2000; 25:1132-1139.
27. Tosteson AN, Lurie JD, Tosteson TD, Skinner JS, Herkowitz H, Albert T, Boden SD, Bridwell K, Longley M, Andersson GB, Blood EA, Grove MR, Weinstein JN; SPORT Investigators. Surgical treatment of spinal stenosis with and without degenerative spondylolisthesis: Cost-effectiveness after 2 years. Ann Intern Med 2008; 149:845-853.
28. Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: A systematic review. Pain Physician 2007; 10:185-212.
29. Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL, Bowman RC, Deer TR, Swice-good JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti L. Interventional techniques: Evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007; 10:7-111.
30. Staal JB, de Bie R, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low back pain. Cochrane Database Syst Rev 2008; 3:CD001824.
31. Botwin K, Brown LA, Fishman M, Rao S. Fluoroscopically guided caudal epidural steroid injections in degenerative lumbar spinal stenosis. Pain Physician 2007; 10:547-558.
32. Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJE, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician 2009: 12:699-802.
33. Manchikanti L, Boswell MV, Datta S, Fellows B, Abdi S, Singh V, Benyamin RM, Falco FJE, Helm S, Hayek S, Smith HS. Comprehensive review of therapeutic interventions in managing chronic spinal pain. Pain Physician 2009: 12:E123-E198.
34. Barre L, Lutz GE, Southern D, Cooper G. Fluoroscopically guided caudal epidural steroid injections for lumbar spinal stenosis: A retrospective evaluation of long-term efficacy. Pain Physician 2004; 7:187-193.
35. Delport EG, Cucuzzella AR, Marley JK, Pruitt CM, Fisher JR. Treatment of lumbar spinal stenosis with epidural steroid injections: A retrospective outcome study. Arch Phys Med Rehabil 2004; 85:479-484.
36. Koc Z, Ozcakir S, Sivrioglu K, Gurbet A, Kucukoglu S. Effectiveness of physical therapy and epidural steroid injections in lumbar spinal stenosis. Spine (Phila Pa 1976) 2009; 34:985-989.
37. Huntoon MC, Burgher AH. Back to the future: The end of the steroid century? Pain Physician 2008; 11:713-716.
38. Epter RS, Helm S, Hayek SM, Benyamin RM, Smith HS, Abdi S. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician 2009; 12:361-378.
39. Trescot AM, Chopra P, Abdi S, Datta S, Schultz DM. Systematic review of effectiveness and complications of adhesiolysis in the management of chronic spinal pain: An update. Pain Physician 2007; 10:129-146.
40. Heavner JE, Racz GB, Raj P. Percutaneous epidural neuroplasty. Prospective evaluation of 0.9% NaCl versus 10% NaCl with or without hyaluronidase. Reg Anesth Pain Med 1999; 24:202-207.
41. Manchikanti L, Rivera J, Pampati V, Damron KS, McManus CD, Brandon DE, Wilson SR. One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: A randomized double blind trial. Pain Physician. 2004; 7:177-186.
42. Manchikanti L, Pampati V, Rivera J, Fellows B, Beyer CD, Damron KS, Cash KA. Effectiveness of percutaneous adhesiolysis and hypertonic saline neurolysis in refractory spinal stenosis. Pain Physician 2001; 4:366-373.
43. Moher D, Schulz KF, Altman D, for the CONSORT Group. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285:1987-1991.
44. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA 2006; 295:1152-1160.
45. Manchikanti L, Hirsch JA, Smith HS. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: Part 2. Randomized controlled trials. Pain Physician 2008; 11:713-775.
46. Manchikanti L. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: Part 1: Introduction and general considerations. Pain Physician 2008; 11:161-186.
47. Manchikanti L, Benyamin RM, Helm S, Hirsch JA. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: Part 3: Systematic reviews and meta-analysis of randomized trials. Pain Physician 2009; 12:35-72.
48. Fairbank JCT, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976) 2000; 25:2940-2953.
49. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: One-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician 2008; 11:121-132.
50. Manchikanti L, Singh V, Falco FJ, Cash KA, Fellows B. Cervical medial branch blocks for chronic cervical facet joint pain: A randomized double-blind, controlled trial with one-year follow-up. Spine (Phila Pa 1976) 2008; 33:1813-1820.
51. Manchikanti L, Singh V, Falco FJE, Cash KA, Pampati V. Effectiveness of thoracic medial branch blocks in managing chronic pain: A preliminary report of a randomized, double-blind controlled trial; Clinical trial NCT00355706. Pain Physician 2008; 11:491-504.
52. Manchikanti L, Cash KA, McManus CD, Pampati V, Smith HS. Preliminary results of randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 1. Discogenic pain without disc herniation or radiculitis. Pain Physician 2008; 11:785-800.
53. Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. Preliminary results of randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 2. Disc herniation and radiculitis. Pain Physician 2008; 11:801-815.
54. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Preliminary results of randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 3. Post surgery syndrome. Pain Physician 2008; 11:817-831.
55. Pereira J, Lawlor P, Vigano A, Dorgan M, Bruera E. Equianalgesic dose ratios for opioids. A critical review and proposals for long-term dosing. J Pain Symptom Manage 2001; 22:672-687. Narcotic analgesic converter, Global-RPh Inc. www.globalrph.com/narcotic.cgi
56. Browner WS, Newman TB, Cummings SR, Hulley SB. Estimating sample size and power. In: Hulley SB, Cummings SR, Browner WS, Grady D, Hearst N, Newman TB (eds). Designing Clinical Research: An Epidemiologic Approach, 2nd ed. Lippincott, Williams & Wilkins, Philadelphia, 2001, pp 65-84.
57. Manchikanti L. Role of neuraxial steroids in interventional pain management. Pain Physician 2002; 5:182-199.
58. Byrod G, Otani K, Brisby H, Rydevik B, Olmarker K. Methylprednisolone reduces the early vascular permeability increase in spinal nerve roots induced by epidural nucleus pulposus application. J Orthop Res 2000; 18:983-987.
59. Pasqualucci A, Varrassi G, Braschi A, Peduto VA, Brunelli A, Marinangeli F, Gori F, Colò F, Paladín A, Mojoli F. Epidural local anesthetic plus corticosteroid for the treatment of cervical brachial radicular pain: Single injection verus continuous infusion. Clin J Pain 2007; 23:551-557.
60. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: A randomized, double-blind, equivalence controlled trial. Pain Physician 2009; in press.
61. Manchikanti L, Singh V, Smith HS, Hirsch JA. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: Part 4: Observational studies. Pain Physician 2009; 12:73-108.
62. Manchikanti L, Datta S, Smith HS, Hirsch JA. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: Part 6. Systematic reviews and meta-analyses of observational studies. Pain Physician 2009; 12:819-850.
63. Hotopf M. The pragmatic randomized controlled trial. Adv Psychiatr Treat 2002; 8:326-333.
64. Hotopf M, Lewis G, Normand C. Putting trials on trial: The costs and consequences of small trials in depression: A systematic review of methodology. J Epidemiol Community Health 1997; 51:354-358.
65. Hotopf M, Churchill R, Lewis G. Pragmatic randomized controlled trials in psychiatry. Br J Psychiatry 1999; 175:217-223.
66. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003; 290:1624-1632.
67. Roland M, Torgerson DJ. What are pragmatic trials? BMJ 1998; 316:285.
68. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Choice of Control Group and Related Issues in Clinical Trials E10. July 20, 2000.
69. Jespersen SM, Hansen ES, Høy K, Christensen KO, Lindblad BE, Ahrensberg J, Bünger C. Two-level spinal stenosis in minipigs: Hemodynamic effects of exercise. Spine (Phila Pa 1976) 1995; 20:2765-2773.
70. Porter RW. Spinal stenosis and neurogenic claudication. Spine (Phila Pa 1976) 1996; 21:2046-2052.
71. Sekiguchi M, Kikuchi S. Experimental studies of lumbar spinal stenosis. Clin Calcium 2005; 15:51-56.
72. Takenobu Y, Katsube N, Marsala M, Kondo K. Model of neuropathic intermittent claudication in the rat: Methodology and application. J Neurosci Methods 2001; 104:191-198.
73. Olmarker K, Holm S, Rosenqvist AL, Rydevik B. Experimental nerve root compression: A model of acute, graded compression of the porcine cauda equina and an analysis of neural and vascular anatomy. Spine (Phila Pa 1976) 1991; 16:61-69.
74. Olmarker K, Rydevik B. Single- versus double-level nerve root compression: An experimental study on the porcine cauda equina with analyses of nerve impulse conduction properties. Clin Orthop Relat Res 1992; 279:35-39.
75. Olmarker K, Rydevik B, Holm S. Edema formation in spinal nerve roots induced by experimental, graded compression: An experimental study on the pig cauda equina with special reference to differences in effects between rapid and slow onset of compression. Spine (Phila Pa 1976) 1989; 14:569-573.
76. Olmarker K, Rydevik B, Holm S, Bagge U. Effects of experimental graded compression on blood flow in spinal nerve roots: A vital microscopic study on the porcine cauda equina. J Orthop Res 1989; 7:817-823.
77. Wheeler AH, Murrey DB. Chronic lumbar spine and radicular pain: Pathophysiology and treatment. Curr Pain Headache Rep 2002; 6:97-105.
78. Hadjipavlou AG, Tzermiadianos MN, Bogduk N, Zindrick MR. The pathophysiology of disc degeneration: A critical review. J Bone Joint Surg Br 2008; 90:1261-1270.
79. Norimoto M, Ohtori S, Yamashita M, Inoue G, Yamauchi K, Koshi T, Suzuki M, Orita S, Eguchi Y, Sugiura A, Ochiai N, Takaso M, Takahashi K. Direct application of the TNF-alpha inhibitor, etanercept, does not affect CGRP expression and phenotypic change of DRG neurons following application of nucleus pulposus onto injured sciatic nerves in rats. Spine (Phila Pa 1976) 2008; 33:2403-2408.
80. Okamoto K, Kobashi G, Washio M, Sasaki S, Yokoyama T, Miyake Y, Sakamoto N, Ohta K, Inaba Y, Tanaka H; Japan Collaborative Epidemiological Study Group for Evaluation of Ossification of the Posterior Longitudinal Ligament of the Spine (OPLL) Risk. Dietary habits and risk of ossification of the posterior longitudinal ligaments of the spine (OPLL); findings from a case-control study in Japan. J Bone Miner Metab 2004; 22:612-617.
81. Kobashi G, Washio M, Okamoto K, Sasaki S, Yokoyama T, Miyake Y, Sakamoto N, Ohta K, Inaba Y, Tanaka H; Japan Collaborative Epidemiological Study Group for Evaluation of Ossification of the Posterior Longitudinal Ligament of the Spine Risk. High body mass index after age 20 and diabetes mellitus are independent risk factors for ossification of the posterior longitudinal ligament of the spine in Japanese subjects: A case-control study in multiple hospitals. Spine (Phila Pa 1976) 2004; 29:1006-1010.
82. Akune T, Ogata N, Seichi A, Ohnishi I, Nakamura K, Kawaguchi H. Insulin secretory response is positively associated with the extent of ossification of the posterior longitudinal ligament of the spine. J Bone Joint Surg Am 2001; 83:1537-1544.
83. Genevay S, Finckh A, Payer M, Mezin F, Tessitore E, Gabay C, Guerne PA. Elevated levels of tumor necrosis factoralpha in periradicular fat tissue in patients with radiculopathy from herniated disc. Spine (Phila Pa 1976) 2008; 33:2041-2046.
84. Sugiura A, Ohtori S, Yamashita M, Inoue G, Yamauchi K, Koshi T, Suzuki M, Norimoto M, Orita S, Eguchi Y, Takahashi Y, Watanabe TS, Ochiai N, Takaso M, Takahashi K. Existence of nerve growth factor receptors, tyrosine kinase a and p75 neurotrophin receptors in intervertebral discs and on dorsal root ganglion neurons innervating intervertebral discs in rats. Spine (Phila Pa 1976) 2008; 33:2047-2051.
85. Yamashita M, Ohtori S, Koshi T, Inoue G, Yamauchi K, Suzuki M, Takahashi K. Tumor necrosis factor-alpha in the nucleus pulposus mediates radicular pain, but not increase of inflammatory peptide, associated with nerve damage in mice. Spine (Phila Pa 1976) 2008; 33:1836-1842.