Prolotherapy Versus Epidural Steroid Injections (ESI) for Lumbar Pain Radiating to the Leg

Summary

The hypothesis is that in the treatment of low back pain (LBP) radiating to the leg, the long-term results of prolotherapy are more effective than those of the current conventional treatment: epidural steroid injections (ESI). This research will examine the efficacy of prolotherapy injections versus epidural steroid injections for the treatment of low back pain radiating to the leg. This is a randomized, unblinded study, in which patients seen in the principle investigator's pain clinic will be randomly divided to receive treatments from either the experimental, prolotherapy group, or the active control, ESI group.

Timeline

Start

2013-12-01

Primary completion

2023-04-01

Completion

2023-04-10

Publications

• Background Benyamin RM, Manchikanti L, Parr AT, Diwan S, Singh V, Falco FJ, Datta S, Abdi S, Hirsch JA. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician. 2012 Jul-Aug;15(4):E363-404.
• Background Manchikanti L, Buenaventura RM, Manchikanti KN, Ruan X, Gupta S, Smith HS, Christo PJ, Ward SP. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician. 2012 May-Jun;15(3):E199-245.
• Background Iguchi T, Kanemura A, Kasahara K, Kurihara A, Doita M, Yoshiya S. Age distribution of three radiologic factors for lumbar instability: probable aging process of the instability with disc degeneration. Spine (Phila Pa 1976). 2003 Dec 1;28(23):2628-33. doi: 10.1097/01.BRS.0000097162.80495.66.
• Background Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available.
• Background Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
• Background Yelland MJ, Del Mar C, Pirozzo S, Schoene ML. Prolotherapy injections for chronic low back pain: a systematic review. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2126-33. doi: 10.1097/01.brs.0000141188.83178.b3.
• Background Wilkinson HA. Injection therapy for enthesopathies causing axial spine pain and the "failed back syndrome": a single blinded, randomized and cross-over study. Pain Physician. 2005 Apr;8(2):167-73.
• Wende O, Reeves KD, Vishnevsky G, Cheng AL, Rabago D. Prolotherapy versus epidural steroid injections for lumbar pain with associated leg pain: A pragmatic randomized controlled trial. PM R. 2026 Apr 29. doi: 10.1002/pmrj.70136. Online ahead of print.

Drugs

Indications