Randomized controlled trial of behavioral skills-based virtual reality (VR) for chronic low back pain: Study protocol for self-administered at-home VR therapy (Preprint)

BACKGROUND Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a non-pharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS We will randomize 180 individuals with cLBP to one of two VR programs: (1) EaseVRx (eight-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a virtual reality headset to minimize any biases related to the technology’s novelty. The Sham VR group had 2-D neutral content in a 3-D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months post-treatment using an approach suitable for the longitudinal nature of the data. RESULTS The study was approved by IRB on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020 and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain’s societal burden. Our study could help shape future research and development of these innovative approaches. CLINICALTRIAL ClinicalTrials.gov, NCT04415177. https://clinicaltrials.gov/ct2/show/NCT04415177