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

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. 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. 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. 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. 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.

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Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Déclaration de conflit d'intérêts

Dr. Maddox, Dr. Oldstone, Roselani Maddox, Kelsey Ffrench, and Takisha Adair are employees of AppliedVR, Inc. Joshua Sackman is president of AppliedVR, Inc. Dr. Sparks is a former employee of AppliedVR, Inc who was employed during execution of the study. Dr. Darnall is chief science advisor for AppliedVR, Inc. Dr. Darnall has authored or coauthored 5 pain treatment books for patients and clinicians and receives royalties for 4. Dr. Darnall is the principal investigator for pain research grants and awards from the National Institutes of Health (NIH) and the Patient-Centered Research Outcomes Research Institute (none specific to the current work). Dr. Darnall is a co-investigator on 2 NIH research grants investigating virtual reality analgesia; neither of these grants is specific to the current work. Dr. Darnall serves on the Board of Directors for the American Academy of Pain Medicine and is on the Board of Directors for the Institute for Brain Potential. Dr. Darnall is a scientific member of the NIH Interagency Pain Research Coordinating Committee, the Centers for Disease Control and Prevention (CDC) Opioid Workgroup (2020–2021), and the Pain Advisory Group of the American Psychological Association.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.