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Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: Follow-up Study of a Randomized Clinical Trial. Journal of medical Internet research Garcia, L., Birckhead, B., Krishnamurthy, P., Mackey, I., Sackman, J., Salmasi, V., Louis, R., Castro, C., Maddox, R., Maddox, T., Darnall, B. D. 2022; 24 (5): e37480

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<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=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.CONCLUSIONS: 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.TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.

View details for DOI 10.2196/37480

View details for PubMedID 35612905