BACKGROUND: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. OBJECTIVE: To conduct a double-blind, parallel arm, single cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. METHODS: A national online convenience sample of individuals with self-reported non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 was enrolled and randomized 1:1 to one of two daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. RESULTS: The study sample was 179 adults (female 77%; caucasian 91%; at least some college education 92%; mean age 51.5 years, SD 13.1; average pain intensity 5/10, SD 1.2; back pain duration > 5 years 67%). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus sham VR (p < 0.0001). For the between-groups factor, EaseVRx was superior to sham VR for all primary outcomes (highest p-value = 0.0090), and between-groups Cohen's d effect sizes ranged from 0.40 to 0.49 indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between group comparisons for physical function and sleep disturbance showed superiority for the EaseVRx group versus the sham VR group (p = 0.0224 and p = 0.0132, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent; MME) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (p < 0.01) but not for sham VR. CONCLUSIONS: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand non-pharmacologic treatment for chronic low back pain. CLINICAL TRIAL: ClinicalTrials.gov NCT04415177. INTERNATIONAL REGISTERED REPORT: Rr2-25291.

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