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

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). 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. 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. 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 (d_s=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (d_s=0.34; P=.02 and d_s=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. RR2-10.2196/25291.