Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Feb 22, 2022
Date Accepted: Apr 26, 2022
Durability of treatment effects for a randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality for chronic low back pain: Six-month follow-up
ABSTRACT
Background:
We previously reported efficacy for 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 (CLBP) were randomized 1:1 to receive either (1) 56-day immersive therapeutic pain relief skills VR program or (2) 56-day sham VR program. Immediate post-treatment results revealed superiority for therapeutic vs. 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 post-treatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and newly for sleep.
Objective:
The current report assessed between-group and within-group treatment effects 6-months post-treatment to determine extended efficacy, magnitude of efficacy, and clinical importance for home-based therapeutic VR.
Methods:
E-surveys were deployed at pre-treatment, end of treatment, and post-treatment months 1, 2, 3, and 6. Self-reported data for N=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 post-treatment; secondary outcomes were PROMIS sleep disturbance and physical function.
Results:
Therapeutic VR maintained significant and clinically meaningful effects 6 months post-treatment and continued superiority over sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (all p’s < 0.003); ds = 0.44 to 0.54). Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (Physical Function: P=.019; ds = 0.34; Sleep Disturbance: P=.0002; ds = 0.46). 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:
An 8-week, home-based VR pain management program confers important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. Clinical Trial: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177
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