Comparative Effectiveness of Fluoroscopy-Guided Caudal Epidural Steroid Injection with or without Hyaluronidase in Chronic Lumbo-Sacral Radiculopathy: A Single-Blind Randomized Clinical Trial
-
Mehrshad Namazi
,
Alireza Khajenasiri
,
Ebrahim Espahbodi
,
Hossein Majedi
,
Babak Eslami
,
Reza Atef-Yekta
Abstract
Background: Chronic lumbosacral radiculopathy involves persistent radicular pain associated with mechanical and inflammatory processes. Caudal epidural steroid injections (ESIs) are commonly used for chronic radicular pain. Hyaluronidase has been proposed as an adjunct to facilitate epidural spread, but evidence regarding its incremental benefit remains limited.
Methods: In this single-blind randomized controlled trial, 40 patients with chronic lumbosacral radiculopathy due to lumbar disc protrusion and/or lumbar canal stenosis were randomly assigned to two groups. Group A received 10 mL of 5% saline, followed by 10 mL of 1% ropivacaine and 40 mg dexamethasone. Group B received 5 mL of 5% saline followed by the same dose of 1% ropivacaine and dexamethasone plus 5 mL containing 1500 U hyaluronidase. All procedures were performed under fluoroscopic guidance. The primary outcome was the change in pain intensity measured by the Numeric Rating Scale (NRS) at 3 months. Secondary outcomes included sleep disturbance, sitting and standing intolerance, neurogenic claudication assessed by walking distance, lower extremity muscle strength, and procedure-related adverse events.
Results: Group B had a greater reduction in NRS at 3 months than Group A (between-group mean difference 1.60, 95% confidence interval [CI] 0.45–2.75; P = 0.009). Sleep disturbance improved more in Group B, with a 54.3% reduction at 3 months (P = 0.012). Neurogenic claudication also improved more in Group B, with 75% of patients able to walk ≥300 meters at 3 months versus 30% in Group A (P = 0.010).
Conclusion: Adding hyaluronidase to fluoroscopy-guided caudal epidural steroid injection was associated with greater pain reduction and improvement in selected functional outcomes over 3 months. These findings warrant confirmation in larger randomized trials with longer follow-up and validated disability measures.
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[7] Budisulistyo T, Husni A, Pramukarso DT, Pudjonarko D. Effect of caudal epidural adhesiolysis plus steroid injections on pain and daily activities among chronic lumbar disc herniation patients; an observational study. Anaesth Pain & Intensive Care. 2023; 27(2):198.
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[19] Acaroğlu E, Nordin M, Randhawa K, Chou R, et al. The Global Spine Care Initiative: a summary of guidelines on invasive interventions for the management of persistent and disabling spinal pain in low- and middle-income communities. Eur Spine J. 2018; 27(Suppl 6):870-878.
[20] Blyth FM, Briggs AM, Schneider CH, Hoy DG, et al. The Global Burden of Musculoskeletal Pain-Where to From Here? Am J Public Health. 2019; 109(1):35-40.
[21] Manchikanti L, Kaye AD, Manchikanti K, Boswell M, et al. Efficacy of epidural injections in the treatment of lumbar central spinal stenosis: a systematic review. Anesth Pain Med. 2015; 5(1):e23139.
[22] Manchikanti L, Nampiaparampil DE, Manchikanti KN, Falco FJ, et al. Comparison of the efficacy of saline, local anesthetics, and steroids in epidural and facet joint injections for the management of spinal pain: A systematic review of randomized controlled trials. Surg Neurol Int. 2015; 6(Suppl 4):S194-235.
[23] Manchikanti L, Benyamin RM, Falco FJ, Kaye AD, et al. Do Epidural Injections Provide Short- and Long-term Relief for Lumbar Disc Herniation? A Systematic Review. Clin Orthop Relat Res. 2015; 473(6):1940-56.
[24] Manchikanti L, Soin A, Boswell MV, Kaye AD, et al. Effectiveness of Percutaneous Adhesiolysis in Post Lumbar Surgery Syndrome: A Systematic Analysis of Findings of Systematic Reviews. Pain Physician. 2019; 22(4):307-322.
[25] Manchikanti L, Knezevic NN, Sanapati MR, Boswell MV, et al. Effectiveness of Percutaneous Adhesiolysis in Managing Chronic Central Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis. Pain Physician. 2019; 22(6):E523-E550.
[26] Manchikanti L, Knezevic NN, Sanapati SP, Sanapati MR, et al. Is Percutaneous Adhesiolysis Effective in Managing Chronic Low Back and Lower Extremity Pain in Post-surgery Syndrome: a Systematic Review and Meta-analysis. Curr Pain Headache Rep. 2020; 24(6):30.
[27] US Department of Health and Human Services. Pain management best practices inter-agency task force report: updates, gaps, inconsistencies, and recommendations. Washington, DC: US Department of Health and Human Services; 2019.
[28] Manchikanti L, Singh V, Kaye AD, Hirsch JA. Lessons for Better Pain Management in the Future: Learning from the Past. Pain Ther. 2020; 9(2):373-391.
[29] Racz GB, Heavner JE. Introduction to Lysis of Adhesions. In: Racz G, Noe C, editors. Techniques of Neurolysis. Springer, Cham; 2016.
[30] Rapčan R, Kočan L, Mláka J, Burianek M, et al. A Randomized, Multicenter, Double-Blind, Parallel Pilot Study Assessing the Effect of Mechanical Adhesiolysis vs Adhesiolysis with Corticosteroid and Hyaluronidase Administration into the Epidural Space During Epiduroscopy. Pain Med. 2018; 19(7):1436-1444.
[31] 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):202-7.
[32] Smith MT, Haythornthwaite JA. How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med Rev. 2004; 8(2):119-32.
[33] Lautenbacher S, Kundermann B, Krieg JC. Sleep deprivation and pain perception. Sleep Med Rev. 2006; 10(5):357-69.
[34] Smith MT, Klick B, Kozachik S, Edwards RE, et al. Sleep onset insomnia symptoms during hospitalization for major burn injury predict chronic pain. Pain. 2008; 138(3):497-506.
[2] Chung SG. Epidural steroid injection in lumbosacral radiculopathy (due to herniated intervertebral disc) efficacy-randomized placebo controlled studies. Clinical Pain. 2007; 6(1):14-23.
[3] Delport EG, Cucuzzella AR, Marley JK, Pruitt CM, et al. Treatment of lumbar spinal stenosis with epidural steroid injections: a retrospective outcome study. Arch Phys Med Rehabil. 2004; 85(3):479-84.
[4] Igarashi T, Hirabayashi Y, Seo N, Saitoh K, et al. Lysis of adhesions and epidural injection of steroid/local anaesthetic during epiduroscopy potentially alleviate low back and leg pain in elderly patients with lumbar spinal stenosis. Br J Anaesth. 2004; 93(2):181-7.
[5] Kim SB, Lee KW, Lee JH, Kim MA, et al. The additional effect of hyaluronidase in lumbar interlaminar epidural injection. Ann Rehabil Med. 2011; 35(3):405-11.
[6] Lee KJ, Han SG, Yoon SH, Kim JS, et al. Nerve root block with corticosteroids, hyaluronidase, and local anesthetic in the failed back surgery syndrome. Korean J Pain. 1999; 12(2):191-194.
[7] Budisulistyo T, Husni A, Pramukarso DT, Pudjonarko D. Effect of caudal epidural adhesiolysis plus steroid injections on pain and daily activities among chronic lumbar disc herniation patients; an observational study. Anaesth Pain & Intensive Care. 2023; 27(2):198.
[8] Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ. 2007; 334(7607):1313-7.
[9] Racz GB, Holubec JT. Lysis of Adhesions in the Epidural Space. In: Racz GB, editor. Techniques of Neurolysis. Current Management of Pain, vol 4. Springer, Boston, MA; 1989.
[10] Leboeuf-Yde C, Nielsen J, Kyvik KO, Fejer R, et al. Pain in the lumbar, thoracic or cervical regions: do age and gender matter? A population-based study of 34,902 Danish twins 20-71 years of age. BMC Musculoskelet Disord. 2009; 10:39.
[11] Manchikanti L, Knezevic NN, Navani A, Christo PJ, et al. Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines. Pain Physician. 2021; 24(S1):S27-S208.
[12] Navani A, Manchikanti L, Albers SL, Latchaw RE, et al. Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. 2019; 22(1S):S1-S74.
[13] Manchikanti L, Kaye AM, Knezevic NN, McAnally H, et al. Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. 2017; 20(2S):S3-S92.
[14] Manchikanti L, Abdi S, Atluri S, Benyamin RM, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013; 16(2 Suppl):S49-283.
[15] Manchikanti L, Kaye AD, Soin A, Albers SL, et al. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines. Pain Physician. 2020; 23(3S):S1-S127.
[16] Manchikanti L, Singh V, Falco FJ, Benyamin RM, et al. Epidemiology of low back pain in adults. Neuromodulation. 2014; 17 Suppl 2:3-10.
[17] Freburger JK, Holmes GM, Agans RP, Jackman AM, et al. The rising prevalence of chronic low back pain. Arch Intern Med. 2009; 169(3):251-8.
[18] World Health Organization. World report on ageing and health. Geneva: World Health Organization; 2015.
[19] Acaroğlu E, Nordin M, Randhawa K, Chou R, et al. The Global Spine Care Initiative: a summary of guidelines on invasive interventions for the management of persistent and disabling spinal pain in low- and middle-income communities. Eur Spine J. 2018; 27(Suppl 6):870-878.
[20] Blyth FM, Briggs AM, Schneider CH, Hoy DG, et al. The Global Burden of Musculoskeletal Pain-Where to From Here? Am J Public Health. 2019; 109(1):35-40.
[21] Manchikanti L, Kaye AD, Manchikanti K, Boswell M, et al. Efficacy of epidural injections in the treatment of lumbar central spinal stenosis: a systematic review. Anesth Pain Med. 2015; 5(1):e23139.
[22] Manchikanti L, Nampiaparampil DE, Manchikanti KN, Falco FJ, et al. Comparison of the efficacy of saline, local anesthetics, and steroids in epidural and facet joint injections for the management of spinal pain: A systematic review of randomized controlled trials. Surg Neurol Int. 2015; 6(Suppl 4):S194-235.
[23] Manchikanti L, Benyamin RM, Falco FJ, Kaye AD, et al. Do Epidural Injections Provide Short- and Long-term Relief for Lumbar Disc Herniation? A Systematic Review. Clin Orthop Relat Res. 2015; 473(6):1940-56.
[24] Manchikanti L, Soin A, Boswell MV, Kaye AD, et al. Effectiveness of Percutaneous Adhesiolysis in Post Lumbar Surgery Syndrome: A Systematic Analysis of Findings of Systematic Reviews. Pain Physician. 2019; 22(4):307-322.
[25] Manchikanti L, Knezevic NN, Sanapati MR, Boswell MV, et al. Effectiveness of Percutaneous Adhesiolysis in Managing Chronic Central Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis. Pain Physician. 2019; 22(6):E523-E550.
[26] Manchikanti L, Knezevic NN, Sanapati SP, Sanapati MR, et al. Is Percutaneous Adhesiolysis Effective in Managing Chronic Low Back and Lower Extremity Pain in Post-surgery Syndrome: a Systematic Review and Meta-analysis. Curr Pain Headache Rep. 2020; 24(6):30.
[27] US Department of Health and Human Services. Pain management best practices inter-agency task force report: updates, gaps, inconsistencies, and recommendations. Washington, DC: US Department of Health and Human Services; 2019.
[28] Manchikanti L, Singh V, Kaye AD, Hirsch JA. Lessons for Better Pain Management in the Future: Learning from the Past. Pain Ther. 2020; 9(2):373-391.
[29] Racz GB, Heavner JE. Introduction to Lysis of Adhesions. In: Racz G, Noe C, editors. Techniques of Neurolysis. Springer, Cham; 2016.
[30] Rapčan R, Kočan L, Mláka J, Burianek M, et al. A Randomized, Multicenter, Double-Blind, Parallel Pilot Study Assessing the Effect of Mechanical Adhesiolysis vs Adhesiolysis with Corticosteroid and Hyaluronidase Administration into the Epidural Space During Epiduroscopy. Pain Med. 2018; 19(7):1436-1444.
[31] 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):202-7.
[32] Smith MT, Haythornthwaite JA. How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med Rev. 2004; 8(2):119-32.
[33] Lautenbacher S, Kundermann B, Krieg JC. Sleep deprivation and pain perception. Sleep Med Rev. 2006; 10(5):357-69.
[34] Smith MT, Klick B, Kozachik S, Edwards RE, et al. Sleep onset insomnia symptoms during hospitalization for major burn injury predict chronic pain. Pain. 2008; 138(3):497-506.
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How to Cite
1.
Namazi M, Khajenasiri A, Espahbodi E, Majedi H, Eslami B, Atef-Yekta R. Comparative Effectiveness of Fluoroscopy-Guided Caudal Epidural Steroid Injection with or without Hyaluronidase in Chronic Lumbo-Sacral Radiculopathy: A Single-Blind Randomized Clinical Trial. Arch Anesth & Crit Care. 2026;.
