Effect of virtual reality-integrated mindfulness-based cognitive therapy on pain and psychological symptoms in chronic non-specific low back pain: protocol for a randomized controlled trial.

Background: Chronic non-specific low back pain (CNLBP) is a common condition associated with persistent pain, functional limitation, reduced quality of life, and substantial healthcare and socioeconomic burden. Mindfulness-based cognitive therapy (MBCT) has been increasingly used in chronic pain management and may provide a promising therapeutic approach for CNLBP. The emergence of virtual reality (VR) further provides an immersive, standardized, and accessible platform for delivering MBCT. This study aims to evaluate the effects and safety of a CNLBP-specific VR-integrated MBCT intervention in patients with CNLBP. Methods: This multi-center, prospective, parallel-group, open-label randomized controlled trial will recruit 214 patients with CNLBP from the pain clinics of three hospitals. Participants will be randomly assigned in a 1:1 ratio to either an 8-week VR-MBCT group consisting of weekly in-clinic VR sessions supplemented by structured audio-guided home practice, or a usual care control group receiving usual care alone, such as pharmacotherapy and physical therapy, using stratified block randomization according to study center and age (≥60 years or <60 years), with block sizes of 2 and 4. The primary outcomes are the proportions of patients achieving at least a 30% improvement from baseline in functional disability, assessed by the Oswestry Disability Index (ODI), and in self-reported back pain bothersomeness, assessed on a 0-10 scale, at week 8. Secondary outcomes include pain intensity, anxiety, depression, sleep quality, kinesiophobia, pain catastrophizing, work productivity, system usability, and use of concomitant treatments. Safety outcomes will include VR-related adverse events, such as vertigo, vomiting and nausea, headache and falls. Assessments will be conducted at baseline, week 4, week 8, and week 26. Data will be analyzed according to the intention-to-treat principle using generalized estimating equations (GEEs). Discussion: This study aims to provide preliminary evidence regarding the efficacy and safety of VR-integrated MBCT as an adjunct to usual care in patients with CNLBP. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT07589790, identifier NCT07589790.