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 (Preprint)

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 (<i>d<sub>s</sub></i>=0.44-0.54; <i>P</i><.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (<i>d<sub>s</sub></i>=0.34; <i>P</i>=.02 and <i>d<sub>s</sub></i>=0.46; <i>P</i><.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. CLINICALTRIAL ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 INTERNATIONAL REGISTERED REPORT RR2-10.2196/25291

Software‐based interventions for low back pain management: A systematic review and meta‐analysis

“…These differences from prior studies may be related to the fact that two of the five studies were pilot studies with very small numbers of participants and that three of the five studies provided only 4 weeks of intervention. Similarly, a double-blind randomized controlled trial study reported that giving patients who are living with low back pain a virtual reality intervention for 8 weeks had no meaningful impact on their level of self-efficacy (Garcia et al, 2021). Given that a prior study that employed interventions like yoga, physical therapy, and education found that self-efficacy had improved after 12 weeks, it is essential to conduct additional research with larger sample sizes and provide interventions for a sufficient period of time.…”