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

Abstract

Background: Individual treatments for chronic low back pain (CLBP) have small magnitude effects. Combining different types of treatments may produce larger effects.

Objective: 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.

Methods: 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.

Results: 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]).

Conclusion: We conclude that it is feasible to conduct a randomized controlled trial combining procedural and behavioral treatments for CLBP.

Clinicaltrials: gov Registration: https://clinicaltrials.gov/ct2/show/NCT03520387.