In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample.

Objective: To determine whether an 8-week, self-administered in-home, behavioral skills virtual reality program for chronic low back pain (RelieVRx) that trains diaphragmatic breathing, biofeedback, cognition and emotion regulation, mindfulness, and pain education skills, is superior to a strong active Sham at day 56 for improving pain intensity and pain interference, in a large real-world sample. Patients and Methods: Participants included a national sample of demographically diverse individuals with self-reported nonmalignant chronic low back pain ≥3 months duration with an average pain intensity and pain interference of ≥4/10. Participants were randomized 1:1 to RelieVRx or active Sham, and data were collected from January 31, 2022, to October 31, 2022. We evaluated group differences in brief pain inventory, pain intensity, and pain interference to day 56 (end of treatment). Results: Of the 1067 participants (772 women, 293 men, and 2 others; mean ± SD age, 50.8±13.2 years) randomized (1:1) into 2 groups: RelieVRx (n=536) and Sham (n=531) comprised the modified intention-to-treat analytic dataset. RelieVRx was superior to Sham for pain intensity and pain interference reductions from pretreatment to day 56 (difference from Sham, pain intensity: 0.406 [0.170-0.642] and pain interference: 0.523 [0.285-0.760]). Pain intensity and interference reductions for RelieVRx at day 56 were clinically meaningful (pain intensity: 2.0 [out of 10] points [1.73-2.06], pain interference: 2.3 points [1.99-2.33]). Conclusion: An 8-week self-administered behavioral skills virtual reality program was found to impart clinically meaningful improvements above a strong active control comparison on pain intensity and pain interference in clinically severe and diverse adults with chronic low back pain. Trial Registration: clinicaltrials.gov Identifier: NCT05263037.