Randomized-controlled trial of skills-based vr vs. distraction vr vs. sham VR for chronic low back pain

Chronic low back pain (cLBP) significantly impacts quality of life, highlighting the need for safe, home-based, non-pharmacological therapies. This study (NCT04409353) evaluated three interventions utilizing Virtual Reality (VR) for managing cLBP. 385 participants were randomized across three groups: Skills-Based VR (biofeedback, interoceptive training, and relaxation), Distraction VR (immersive 360-degree videos), and Sham VR (2D videos). The primary outcome was the change in PROMIS Pain Interference (PI). Secondary outcomes included the change in physical function, anxiety, depression, sleep disturbance, opioid use, and Fitbit-measured steps and sleep efficiency. No significant differences were observed between active VR (Skills-Based and Distraction) and Sham VR for the primary or most secondary outcomes. Secondary findings indicated a greater reduction in daily opioid use in the Distraction VR group compared to Sham VR (p = 0.009), and exploratory analyses revealed that baseline anxiety significantly predicted PROMIS-PI improvement within the Skills-Based VR (p = 0.025) group. Depression symptoms showed no such association. Adverse events were predominantly mild and self-limited, with cybersickness being the most common. Neither active VR program outperformed Sham VR for the primary outcome. High adherence across groups underscored the feasibility of home-based VR. Future studies, powered to test anxiety-moderated treatment effects and opioid-use reduction as primary outcomes, are warranted.