Prolotherapy versus epidural steroid injections for lumbar pain with associated leg pain: A pragmatic randomized controlled trial.

BACKGROUND: Chronic low back pain with associated leg pain (CLBP-L) (whether referred or radiating) is a common, debilitating, and expensive condition. Epidural steroid injections (ESI) are commonly used, although effectiveness is often limited. Dextrose prolotherapy injections (DPT) are a potential alternative treatment to address the biomechanical and neurological causes of CLBP-L. OBJECTIVE: To assess the effectiveness of DPT compared with ESI for CLBP-L. DESIGN: Pragmatic unblinded, randomized controlled trial. SETTING: Outpatient pain clinic; ESIs were performed in an operating room, DPT in a clinic procedure room. PARTICIPANTS: Adults aged between 18 and 90 years with at least 12 weeks of CLBP-L, and at least 6 on a 0-10 point leg pain severity numerical rating scale (NRS). INTERVENTIONS: Up to three monthly injections for ESI participants; up to five monthly treatments for DPT participants. MAIN OUTCOME MEASURES: Least square mean (LSM) analysis of NRS 0-10 point pain scale (primary) and Oswestry Disability Index (secondary) at 1, 3, 6, and 12 months after treatment completion, using intention to treat analysis. RESULTS: 23 months CLBP-L) were randomized (55 DPT, 49 ESI) and analyzed. No baseline differences existed between groups. DPT outperformed ESI in LSM pain scores at 6 (5.1 ± 0.7 vs. 7.2 ± 0.75 points; p < .001) and 12 m(5.2 ± 0.7 vs. 6.9 ± 0.7 points; p = .001) months. Function score LSMs also favored the DPT group at 6 (33 ± 5 vs. 45 ± 4.5 points; p < .001) and 12 (34 ± 4.5 vs. 42 ± 5 points; p = .012) months. There were no adverse events. CONCLUSIONS: For participants with CLBP-L, DPT resulted in statistically significant and clinically meaningful improvement of pain and function compared with ESI at 1 year after treatment completion. DPT may be an appropriate alternative for patients with CLBP-L. CLINICAL TRIALS: NCT01934868, registered on August 30, 2013.