Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial

Laxmaiah Manchikanti, Vijay Singh, Kimberly A Cash, Vidyasagar Pampati, Laxmaiah Manchikanti, Vijay Singh, Kimberly A Cash, Vidyasagar Pampati

Abstract

Background: The literature is replete with evaluations of failed surgery, illustrating a 9.5%-25% reoperation rate. Speculated causes of post lumbar surgery syndrome include epidural fibrosis, acquired stenosis, recurrent disc herniation, sacroiliac joint pain, and facet joint pain among other causes.

Methods: Patients (n = 120) were randomly assigned to two groups with a 2-year follow-up. Group I (control group, n = 60) received caudal epidural injections with catheterization up to S3 with local anesthetic (lidocaine 2%, 5 mL), nonparticulate betamethasone (6 mg, 1 mL), and 6 mL of 0.9% sodium chloride solution. Group II (intervention group, n = 60) received percutaneous adhesiolysis of the targeted area, with targeted delivery of lidocaine 2% (5 mL), 10% hypertonic sodium chloride solution (6 mL), and nonparticulate betamethasone (6 mg). The multiple outcome measures included the Numeric Rating Scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as 50% improvement in pain and Oswestry Disability Index scores.

Results: Significant improvement with at least 50% relief with pain and improvement in functional status was illustrated in 82% of patients at the 2-year follow-up in the intervention group compared to 5% in the control group receiving caudal epidural injections. The average number of procedures over a period of 2 years in Group II was 6.4 ± 2.35 with overall total relief of approximately 78 weeks out of 104 weeks.

Conclusion: The results of this study show significant improvement in 82% of patients over a period of 2 years with an average of six to seven procedures of 1-day percutaneous adhesiolysis in patients with failed back surgery syndrome.

Keywords: epidural adhesions; epidural fibrosis; epidural steroid injections.

Figures

Figure 1
Figure 1
Schematic presentation of patient flow at 2-year follow-up.
Figure 2
Figure 2
Proportion of patients with significant relief (≥50%) in average pain score (Numeric Rating Scale and Oswestry Disability Index).

References

    1. Tosteson AN, Tosteson TD, Lurie JD, et al. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976) 2011;36(24):2061–2068.
    1. Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010;303(13):1259–1265.
    1. Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979–1990. Spine (Phila Pa 1976) 1994;19(10):1117–1123.
    1. Hu RW, Jaglal S, Axcell T, Anderson G. A population-based study of reoperations after back surgery. Spine (Phila Pa 1976) 1997;22(19):2265–2270.
    1. Malter AD, McNeney B, Loeser JD, Deyo RA. 5-year reoperation rates after different types of lumbar spine surgery. Spine (Phila Pa 1976) 1998;23(7):814–820.
    1. Keskimaki I, Seitsalo S, Osterman H, Rissanen P. Reoperations after lumbar disc surgery: a population-based study of regional and interspecialty variations. Spine (Phila Pa 1976) 2000;25(12):1500–1508.
    1. Waddell G, Kummel EG, Lotto WN, Graham JD, Hall H, McCulloch JA. Failed lumbar disc surgery and repeat surgery following industrial injuries. J Bone Joint Surg Am. 1979;61(2):201–207.
    1. Ross JS, Robertson JT, Frederickson RC, et al. ADCON-L European Study Group. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. Neurosurgery. 1996;38(4):855–861.
    1. Fritsch EW, Heisel J, Rupp S. The failed back surgery syndrome: reasons, intraoperative findings, and long-term results: a report of 182 operative treatments. Spine (Phila Pa 1976) 1996;21(5):626–633.
    1. Osterman H, Sund R, Seitsalo S, Keskimaki I. Risk of multiple reoperations after lumbar discectomy: a population-based study. Spine (Phila Pa 1976) 2003;28(6):621–627.
    1. Law JD, Lehman RA, Kirsch WM. Reoperation after lumbar intervertebral disc surgery. J Neurosurg. 1978;48(2):259–263.
    1. Rajaee SS, Bae HW, Kanim LE, Delamarter RB. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine (Phila Pa 1976) 2012;37(1):67–76.
    1. Martin BI, Mirza SK, Flum DR, et al. Repeat surgery after lumbar decompression for herniated disc: the quality implications of hospital and surgeon variation. Spine J. 2012;12(2):89–97.
    1. Deyo RA, Martin BI, Kreuter W, Jarvik JG, Angier H, Mirza SK. Revision surgery following operations for lumbar stenosis. J Bone Joint Surg Am. 2011;93(21):1979–1986.
    1. Helm S, 2nd, Benyamin RM, Chopra P, Deer TR, Justiz R. Percutaneous adhesiolysis in the management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: a systematic review. Pain Physician. 2012;15(4):E435–E462.
    1. Parr AT, Manchikanti L, Hameed H, et al. Caudal epidural injections in the management of chronic low back pain: a systematic appraisal of the literature. Pain Physician. 2012;15(3):E159–E198.
    1. Simopoulos TT, Manchikanti L, Singh V, et al. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain Physician. 2012;15(3):E305–E344.
    1. Hansen H, Manchikanti L, Simopoulous TT, et al. A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions. Pain Physician. 2012;15(3):E247–E278.
    1. Manchikanti L, Boswell MV, Singh V, et al. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009;12(4):699–802.
    1. Manchikanti L, Manchukonda R, Pampati V, Damron KS, McManus CD. Prevalence of facet joint pain in chronic low back pain in postsurgical patients by controlled comparative local anesthetic blocks. Arch Phys Med Rehabil. 2007;88(4):449–455.
    1. Brzezicki G, Jankowski R, Blok T, Klimczak A, et al. Postlaminectomy osteopontin expression and associated neurophysiological findings in rat peridural scar model. Spine (Phila Pa 1976) 2011;36(5):378–385.
    1. Ronnberg K, Lind B, Zoega B, et al. Peridural scar and its relation to clinical outcome: a randomised study on surgically treated lumbar disc herniation patients. Eur Spine J. 2008;17(12):1714–1720.
    1. Almeida DB, Prandini MN, Awamura Y, et al. Outcome following lumbar disc surgery: the role of fibrosis. Acta Neurochir (Wien) 2008;150(11):1167–1176.
    1. Jou IM, Tai TW, Tsai CL, Tsai TM, Yung WS, Jung YC. Spinal somatosensory evoked potential to evaluate neurophysiologic changes associated with postlaminotomy fibrosis: an experimental study. Spine (Phila Pa 1976) 2007;32(19):2111–2118.
    1. Alkalay RN, Kim DH, Urry DW, Xu J, Parker TM, Glazer PA. Prevention of postlaminectomy epidural fibrosis using bioelastic materials. Spine (Phila Pa 1976) 2003;28(15):1659–1665.
    1. Ozer AF, Oktenoglu T, Sasani M, et al. Preserving the ligamentum flavum in lumbar discectomy: a new technique that prevents scar tissue formation in the first 6 months postsurgery. Neurosurgery. 2006;59(1 Suppl 1):ONS126–ONS133.
    1. Cooper RG, Freemont AJ, Hoyland JA, et al. Herniated intervertebral disc-associated periradicular fibrosis and vascular abnormalities occur without inflammatory cell infiltration. Spine (Phila Pa 1976) 1995;20(5):591–598.
    1. Schimizzi AL, Massie JB, Murphy M, et al. High-molecular-weight hyaluronan inhibits macrophage proliferation and cytokine release in the early wound of a preclinical postlaminectomy rat model. Spine J. 2006;6(5):550–556.
    1. Massie JB, Huang B, Malkmus S, et al. A preclinical post laminectomy rat model mimics the human post laminectomy syndrome. J Neurosci Methods. 2004;137(2):283–289.
    1. Haq I, Cruz-Almeida Y, Siqueira EB, Norenberg M, Green BA, Levi AD. Postoperative fibrosis after surgical treatment of the porcine spinal cord: a comparison of dural substitutes. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine. 2005;2(1):50–54.
    1. Abbott ZI, Nai KV, Allen RR, Akuthota VR. Utilization characteristics of spinal interventions. Spine J. 2012;12(1):35–43.
    1. Manchikanti L, Pampati V, Boswell MV, Smith HS, Hirsch JA. Analysis of the growth of epidural injections and costs in the Medicare population: a comparative evaluation of 1997, 2002, and 2006 data. Pain Physician. 2010;13(3):199–212.
    1. Manchikanti L, Pampati V, Falco FJ, Hirsch JA. Growth of spinal interventional pain management techniques: analysis of utilization trends and Medicare expenditures 2000 to 2008. Spine (Phila Pa 1976) 2012 Jul 11; [Epub ahead of print.]
    1. Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010;13(6):509–521.
    1. 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, equivalence controlled trial. Pain Physician. 2009;12(6):E355–E368.
    1. Manchikanti L, Singh V, Cash KA, Pampati V, Damron KS, Boswell MV. A randomized, controlled, double-blind trial of fluoroscopic caudal epidural injections in the treatment of lumbar disc herniation and radiculitis. Spine (Phila Pa 1976) 2011;36(23):1897–1905.
    1. Manchikanti L, Cash RA, McManus CD, Pampati V, Fellows B. Fluoroscopic caudal epidural injections with or without steroids in managing pain of lumbar spinal stenosis: one year results of randomized, double-blind, active-controlled trial. J Spinal Disord Tech. 2012;25(4):226–234.
    1. Manchikanti L, Cash KA, McManus CD, Pampati V, Smith HS. One-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections with or without steroids in managing chronic discogenic low back pain without disc herniation or radiculitis. Pain Physician. 2011;14(1):25–36.
    1. Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010;13(2):E91–E110.
    1. Yousef AA, El-Deen AS, Al-Deeb AE. The role of adding hyaluronidase to fluoroscopically guided caudal steroid and hypertonic saline injection in patients with failed back surgery syndrome: a prospective, double-blinded, randomized study. Pain Pract. 2010;10(6):548–553.
    1. Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions – evidence for safety and efficacy. Pain Pract. 2008;8(4):277–286.
    1. Racz GB, Day MR, Heavner JE, et al. Epidural lysis of adhesions and percutaneous neuroplasty. In: Racz GB, Noe CE, editors. Pain Management: Current Issues and Opinions. New York, NY: InTech; 2012. pp. 337–370.
    1. Manchikanti L, Falco FJ, Boswell MV, Hirsch JA. Facts, fallacies, and politics of comparative effectiveness research: part 1. Basic considerations. Pain Physician. 2010;13(1):E23–E54.
    1. Manchikanti L, Falco FJ, Boswell MV, Hirsch JA. Facts, fallacies, and politics of comparative effectiveness research: part 2. Implications for interventional pain management. Pain Physician. 2010;13:E55–E79.
    1. Manchikanti L, Falco FJ, Benyamin RM, Helm S, 2nd, Parr AT, Hirsch JA. The impact of comparative effectiveness research on interventional pain management: evolution from Medicare Modernization Act to Patient Protection and Affordable Care Act and the Patient-Centered Outcomes Research Institute. Pain Physician. 2011;14:E249–E282.
    1. Manchikanti L, Datta S, Derby R, Wolfer LR, Benyamin RM, Hirsch JA. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 1. Diagnostic interventions. Pain Physician. 2010;13(3):E141–E174.
    1. Manchikanti L, Datta S, Gupta S, et al. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. 2010;13(4):E215–E264.
    1. Chou R, Atlas SJ, Loeser JD, Rosenquist RW, Stanos SP. Guideline warfare over interventional therapies for low back pain: can we raise the level of discourse? J Pain. 2011;12(8):833–839.
    1. Manchikanti L, Benyamin RM, Falco FJ, Caraway DL, Datta S, Hirsch JA. Guidelines warfare over interventional techniques: is there a lack of discourse or straw man? Pain Physician. 2012;15(1):E1–E26.
    1. Altman DG, Schulz KF, Moher D, et al. CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663–694.
    1. 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-analyses of randomized trials. Pain Physician. 2009;12(1):35–72.
    1. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976) 2000;25(22):2940–2952.
    1. Manchikanti L, Singh V, Falco FJ, Cash KA, Fellows B. Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial. Pain Physician. 2010;13(5):437–450.
    1. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010;7(3):124–135.
    1. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V, Fellows B. Comparative effectiveness of a one-year follow-up of thoracic medial branch blocks in management of chronic thoracic pain: a randomized, double-blind active controlled trial. Pain Physician. 2010;13(6):535–548.
    1. Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010;13(4):E265–E278.
    1. Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. The effectiveness of fluoroscopic cervical interlaminar epidural injections in managing chronic cervical disc herniation and radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010;13(3):223–236.
    1. Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A preliminary report of a randomized double-blind, active controlled trial of fluoroscopic thoracic interlaminar epidural injections in managing chronic thoracic pain. Pain Physician. 2010;13(6):E357–E369.
    1. Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010;13(4):343–355.
    1. Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. Preliminary results of a randomized, double-blind, controlled trial of fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar discogenic pain without disc herniation or radiculitis. Pain Physician. 2010;13(4):E279–E292.
    1. Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012;15(1):51–63.
    1. Manchikanti L, Cash KA, Pampati V, Malla Y. Fluoroscopic cervical epidural injections in chronic axial or disc-related neck pain without disc herniation, facet joint pain, or radiculitis. J Pain Res. 2012;5:227–236.
    1. Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin R. Fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar axial or discogenic pain. J Pain Res. 2012;5:301–311.
    1. Manchikanti L, Singh V, Cash KA, Pampati V, Falco FJ. The role of fluoroscopic interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind trial. Pain Pract. 2012
    1. Manchikanti L, Singh V, Falco FJE, Cash KA, Pampati V, Fellows B. The role of thoracic medial branch blocks in managing chronic mid and upper back pain: a randomized, double-blind, active-control trial with a 2-year follow-up. Anesthesiol Res Pract. 2012;2012:585806.
    1. Pereira J, Lawlor P, Vigano A, Dorgan M, Bruera E. J Pain Symptom Manage. 2. Vol. 22. Narcotic analgesic converter, GlobalRPh Inc; 2001. [Accessed April 7, 2010]. Equianalgesic dose ratios for opioids. A critical review and proposals for long-term dosing; pp. 672–687. .
    1. Manchikanti L, Rivera JJ, Pampati V, et al. 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(2):177–186.
    1. Browner WS, Newman TB, Cummings SR, Hulley SB. Estimating sample size and power: the nitty-gritty. In: Hulley SB, Cummings SR, Browner WS, Grady D, Hearst N, Newman TB, editors. Designing Clinical Research: An Epidemiologic Approach. 2nd ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 2001. pp. 65–91.
    1. Manchikanti L. Role of neuraxial steroids in interventional pain management. Pain Physician. 2002;5(2):182–199.
    1. 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(6):983–987.
    1. Hayashi N, Weinstein JN, Meller ST, Lee HM, Spratt KF, Gebhart GF. The effect of epidural injection of betamethasone or bupivacaine in a rat model of lumbar radiculopathy. Spine (Phila Pa 1976) 1998;23(8):877–885.
    1. Lee HM, Weinstein JN, Meller ST, Hayashi N, Spratt KF, Gebhart GF. The role of steroids and their effects on phospholipase A2. An animal model of radiculopathy. Spine (Phila Pa 1976) 1998;23(11):1191–1196.
    1. Bhatia MT, Parikh CJ. Epidural-saline therapy in lumbosciatic syndrome. J Indian Med Assoc. 1966;47(11):537–542.
    1. Gupta AK, Mital VK, Azmi RU. Observations of the management of lumbosciatic syndromes (sciatica) by epidural saline. J Indian Med Assoc. 1970;54(5):194–196.
    1. Wittenberg RH, Greskotter KR, Steffen R, Schoenfeld BL. Is epidural injection treatment with hypertonic saline solution in intervertebral disk displacement useful? (The effect of NaCl solution on intervertebral disk tissue) Z Orthop Ihre Grenzgeb. 1990;128(2):223–226. German.
    1. Pasqualucci A, Varrassi G, Braschi A, et al. Epidural local anesthetic plus corticosteroid for the treatment of cervical brachial radicular pain: single injection verus continuous infusion. Clin J Pain. 2007;23(7):551–557.
    1. Pasqualucci A. Experimental and clinical studies about the preemptive analgesia with local anesthetics. Possible reasons of the failure. Minerva Anestesiol. 1998;64(10):445–457.
    1. Cassuto J, Sinclair R, Bonderovic M. Anti-inflammatory properties of local anesthetics and their present and potential clinical implications. Acta Anaesthesiol Scand. 2006;50(3):265–282.
    1. 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(3):202–207.
    1. Tachihara H, Sekiguchi M, Kikuchi S, Konno S. Do corticosteroids produce additional benefit in nerve root infiltration for lumbar disc herniation? Spine (Phila Pa 1976) 2008;33(7):743–747.
    1. Sato C, Sakai A, Ikeda Y, Suzuki H, Sakamoto A. The prolonged analgesic effect of epidural ropivacaine in a rat model of neuropathic pain. Anesth Analg. 2008;106(1):313–320.
    1. Carette S, Leclaire R, Marcoux S, et al. Epidural corticosteroid injections for sciatica due to herniated nucleus pulposus. N Engl J Med. 1997;336(23):1634–1640.
    1. Karppinen J, Malmivaara A, Kurunlahti M, et al. Periradicular infiltration for sciatica: a randomized controlled trial. Spine (Phila Pa 1976) 2001;26(9):1059–1067.
    1. Manchikanti L, Giordano J, Fellows B, Hirsch JA. Placebo and nocebo in interventional pain management: a friend or a foe – or simply foes? Pain Physician. 2011;14(2):E157–E175.
    1. Smuck M, Levin JH. Re: Manchikanti L, Singh V, Falco FJ, et al. 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. Spine (Phila Pa 1976) 2009;34(10):1116.
    1. Indahl A, Kaigle AM, Reikeras O, Holm SH. Interaction between the porcine lumbar intervertebral disc, zygapophysial joints, and paraspinal muscles. Spine (Phila Pa 1976) 1997;22(24):2834–2840.
    1. Indahl A, Kaigle A, Reikeras O, Holm S. Electromyographic response of the porcine multifidus musculature after nerve stimulation. Spine (Phila Pa 1976) 1995;20(24):2652–2658.
    1. Pham Dang C, Lelong A, Guilley J, et al. Effect on neurostimulation of injectates used for perineural space expansion before placement of a stimulating catheter: normal saline versus dextrose 5% in water. Reg Anesth Pain Med. 2009;34(5):398–403.
    1. Tsui BC, Kropelin B, Ganapathy S, Finucane B. Dextrose 5% in water: fluid medium for maintaining electrical stimulation of peripheral nerves during stimulating catheter placement. Acta Anaesthesiol Scand. 2005;49(10):1562–1565.
    1. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010;11(8):1149–1168.
    1. ICH Expert Working Group. ICH Harmonised Tripartite Guideline: Choice of Control Group and Related Issues in Clinical Trials E10. Geneva: ICH; 2000. [Accessed November 19, 2012]. Available from: .

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