Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial

Abstract

Background: We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). Objective: This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. Methods: E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. Results: Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P