Combining Procedural and Behavioral Treatments for Chronic Low Back Pain: A Pilot Randomized Controlled Trial

Research Objectives: The primary aim was to evaluate the feasibility of conducting a factorial randomized controlled trial (RCT) of lumbar medial branch nerve radiofrequency ablation (LRFA) and video-based cognitive behavioral therapy (vCBT) for treatment of chronic low back pain (CLBP), each compared to an active control condition. The secondary aim was to estimate individual and combined treatment effects of (1) LRFA (vs. a simulated LRFA control procedure) and (2) vCBT (vs. an educational control treatment) on back-related disability at 3 months post-randomization.

Design: Feasibility study, 2x2 factorial RCT

Setting: Veterans Affairs (VA) Pain Clinic

Participants: Consecutive sample of adults with CLBP receiving lumbar medial branch blocks (MBBs) in usual clinical screening for LRFA. Of n=26 eligible patients, n=16 enrolled and n=13 were randomized and completed study procedures. No participants withdrew after randomization.

Interventions: Participants were randomized to LRFA vs. simulated LRFA, and simultaneously to vCBT vs. educational control.

Main Outcome Measures: Roland-Morris Disability Questionnaire (RMDQ) at 3 months

Results: All participants completed 3-month follow-up and study processes appeared feasible. Though not statistically significant, there was a beneficial, moderate-magnitude effect of LRFA vs. control on 3-month RMDQ (-3.25 RMDQ points; 95% CI: -10.18, 3.67). There was a significant, beneficial, large-magnitude effect of vCBT vs. control (-6.29, 95% CI: -10.97, -1.60). Though not statistically significant, there was a beneficial, large effect of LRFA+vCBT vs. control (-8.37; 95% CI: -21.47, 4.74).

Conclusions: It was feasible to conduct an RCT combining procedural and behavioral treatments for CLBP. Point estimates suggested beneficial effects of LRFA and vCBT, with insufficient evidence for additive interactions between treatments, but only the effect of vCBT was statistically significant.

Author(s) Disclosures: No conflicts to disclose.