Pain Rehabilitation Virtual Reality (PR-VR) at Home: A Pilot Randomized Controlled Trial for Youth with Chronic Pain.

Background: Pain Rehabilitation Virtual Reality (PR-VR) is a novel tool designed to engage youth with chronic pain in exercise as a part of physiotherapy. PR-VR has been evaluated in day-treatment and outpatient settings, but not for at home use. Aims: To evaluate the feasibility, acceptability and safety of PR-VR at home for youth with chronic pain. An exploratory aim evaluated the preliminary effectiveness of PR-VR on pain and disability. Methods: This was a 3-arm pilot randomized controlled trial (registration #NCT04912817). Each study arm included four 60-min physiotherapy sessions via Zoom (1: commercially available VR; 2: custom-developed PR-VR; 3: standard physiotherapy care). Feasibility metrics included enrollment, accrual, and drop-out rates. Acceptability was measured via satisfaction surveys and qualitative interviews. Pain and disability were measured via self-report, physical performance, and actigraphy. Results: Thirty-seven of 70 eligible patients approached were enrolled and randomized (53% enrollment rate, 100% accrual rate), including 28 females (76%) aged 10-17 years. Twenty-eight participants completed the study (33% drop-out rate; reasons include pain resolution, medical complexity, dissatisfaction with assignment to control). Ten minor adverse events were reported across study arms. Participants and physiotherapists expressed high levels of VR acceptability. Of the participants who completed arms 1 and 2 (n = 17), 94% were satisfied/very satisfied with VR and 100% rated VR as easy/very easy to use. Conclusions: Results from this study demonstrate the safety and acceptability of VR in pediatric pain rehabilitation. These feasibility results will inform the design of future large-scale trials, including consideration of a wait-list control group. Trial Registration: ClinicalTrials.gov, NCT04912817.