Twelve-month results for a randomized sham-controlled effectiveness trial of an in-home skills-based virtual reality program for chronic low back pain

Introduction: Low-risk, accessible, and long-term effective nonpharmacologic behavioral interventions for chronic low back pain (cLBP) are needed. Pain education and cognitive behavioral therapy (CBT) are recommended first-line treatments, but access is poor, treatment effectiveness is variable, and long-term effectiveness is inconsistent. In-home virtual reality (VR)-delivered therapies might address these shortcomings because therapeutic content can be delivered in a consistent and quality-controlled manner. Objective: To determine whether a 56-session, self-administered in-home, Skills-Based VR program for cLBP (RelieVRx) yields long-term reductions in pain intensity and pain interference 12 months posttreatment in a large demographically diverse and clinically severe real-world sample. Methods: Participants were 1,093 demographically diverse individuals with self-reported nonmalignant cLBP >= 3 months duration and average pain intensity and interference scores >= 4/10. Participants were randomized to Skills-Based VR or active Sham, and data were collected from January 31, 2022 to October 31, 2023. Pretreatment to 12-month posttreatment analyses were conducted. Results: From baseline to 12 months posttreatment, Skills-Based VR reductions for average pain intensity (1.7 +/- 2.1) and pain interference (1.9 +/- 2.3) were robust and significantly greater than those found for Sham. More than half of Skills-Based VR participants reported at least a 2-point reduction in pain intensity, pain interference, or both at 12 months posttreatment. Conclusions: A standardized, in-home Skills-Based VR therapy is effective for reducing pain intensity and pain interference, and these effects are maintained to 12 months posttreatment.