Study of Virtual Reality-Based Mindfulness Cognitive Therapy for Adults With Chronic Nonspecific Low Back Pain

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a virtual reality-based mindfulness-based cognitive therapy VR-MBCT as an additional treatment for adults with chronic nonspecific low back pain CNLBP. This multi-center, open-label, randomized controlled trial will include 214 participants aged 20 to 70 years who have had pain for at least 3 months and report significant bothersomeness. The study aims to measure improvements in disability and back pain bothersomeness after 8 weeks of intervention. Participants will be randomly assigned to one of two groups an 8-week VR-MBCT program plus usual care, or a waitlist control group receiving usual care only during the study period. The VR-MBCT group will participate in weekly 30-minute in-clinic VR sessions and at least three home audio practice sessions each week, following a progressive curriculum designed to address cognitive and emotional aspects of pain. After the 26-week follow-up, control group participants will have the option to receive the VR-MBCT program. Throughout the study, assessments will be conducted at baseline, week 4, week 8, and week 26 to evaluate disability, pain bothersomeness, pain intensity, mood, physical activity, sleep quality, fear-avoidance beliefs, pain catastrophizing, work productivity, treatment use, usability of the VR system, and patient satisfaction. Safety monitoring will focus on VR-related adverse events like dizziness or nausea. Data analysis will follow rigorous standards to provide evidence on the role of VR-MBCT as a non-drug adjunct therapy for CNLBP.

Effect of VR-MBCT in Chronic Nonspecific Low Back Pain