Clinical Trial

Effect of VR-MBCT in Chronic Nonspecific Low Back Pain

Study acronym: VR-MBCT-CNLBP
Recruiting
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Summary
This is a multi-center, prospective, open-label randomized controlled trial evaluating the efficacy and safety of virtual reality-based mindfulness-based cognitive therapy (VR-MBCT) as an adjunct to usual care in adults with chronic nonspecific low back pain (CNLBP). A total of 214 participants aged 20-70 years with pain duration ≥3 months and average back pain bothersomeness ≥4 (0-10 scale) will be enrolled from three hospitals in China and randomized 1:1 to an 8-week VR-MBCT intervention group or a waitlist usual care control group. The co-primary outcomes are the proportions of patients achieving ≥30% improvement from baseline in Oswestry Disability Index (ODI) and self-rated back pain bothersomeness at week 8. Secondary outcomes include pain intensity (NRS), global improvement, anxiety (GAD-7), depression (PHQ-9), physical activity (IPAQ-SF), sleep quality (SQS), fear-avoidance beliefs (FABQ-PA), pain catastrophizing (PCS), work productivity (WPAI-GH), treatment use, system usability (SUS), and patient satisfaction. Safety will be monitored for VR-related adverse events. Assessments will be performed at baseline (T0), week 4 (T1), week 8 (T2), and week 26 (T3). Data will be analyzed following the intention-to-treat principle using mixed-effects models and per-protocol analyses.
Trial Details
NCT Number NCT07589790
Lead Sponsor The First Affiliated Hospital of Soochow University
Collaborators: The Fourth Affiliated Hospital of Soochow University, Sir Run Run Shaw Hospital
Conditions Chronic Non-specific Low Back Pain
Enrollment 214 participants
Start Date 2026-04-01
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-15