Combining procedural and behavioral treatments for chronic low back pain: A pilot feasibility randomized controlled trial.

Abstract

Individual treatments for chronic low back pain (CLBP) have small magnitude effects. Combining different types of treatments may produce larger effects. To (1) assess feasibility of conducting a factorial randomized controlled trial of these treatments; and (2) estimate individual and combined treatment effects of (a) lumbar radiofrequency ablation (LRFA) of the dorsal ramus medial branch nerves (vs. a simulated LRFA control procedure) and (b) Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program for CLBP (AcTIVE-CBT) (vs. an educational control treatment) on back-related disability at 3 months post-randomization. Participants (n = 13) were randomized in a 1:1:1:1 ratio in a 2 × 2 factorial randomized controlled trial. Feasibility goals included an enrollment proportion ≥ 30%, a randomization proportion ≥ 80%, and a ≥ 80% proportion of randomized participants completing the 3-month Roland-Morris Disability Questionnaire (RMDQ) primary outcome end point. An intent-to-treat analysis was used. The enrollment proportion was 62%, the randomization proportion was 81%, and all randomized participants completed the primary outcome. Though not statistically significant, there was a beneficial, moderate-magnitude effect of LRFA versus control on 3-month RMDQ (-3.25 RMDQ points [95% confidence interval [CI], -10.18 to 3.67]). There was a significant, beneficial, large-magnitude effect of AcTIVE-CBT versus control (-6.29 [95% CI, -10.97 to -1.60]). Though not statistically significant, there was a beneficial, large effect of LRFA+AcTIVE-CBT versus control (-8.37 [95% CI: -21.47, 4.74]). We conclude that it is feasible to conduct a randomized controlled trial combining procedural and behavioral treatments for CLBP. gov Registration: https://clinicaltrials.gov/ct2/show/NCT03520387.