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

One hundred twelve participants were enrolled; eight withdrew from the study before receiving therapy; 104 participants (53% female; 58 ± $$ \pm $$ 15 years old; body mass index 28 ± 5 kg/m2, with 19 ± $$ \pm $$ 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.