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.
Chronic nonspecific low back pain (CNLBP) is a leading global cause of disability, yet conventional treatments often focus on structural damage and neglect cognitive, emotional, and behavioral dimensions. Mindfulness-based cognitive therapy (MBCT) is effective for chronic pain but limited by therapist resources and low adherence. Virtual reality (VR) provides an immersive, standardized platform to improve treatment fidelity, engagement, and scalability. This multi-center randomized controlled trial investigates a tailored 8-week VR-MBCT intervention for CNLBP. The intervention group receives a hybrid VR-MBCT program consisting of 1 weekly in-clinic VR session (approximately 30 minutes) plus at least 3 home-based audio practice sessions (20-30 minutes per session) for 8 weeks. The progressive curriculum includes automatic pilot and awareness, body scan, mindful movement, graded exposure, responding versus reacting, cognitive defusion, self-compassion, relapse prevention, self-care, and real-world transfer training. The control group receives usual medical care only during the 8-week study period and will be offered the same VR-MBCT intervention after completing the 26-week follow-up. Outcome assessments are conducted at baseline (T0), week 4 (T1), week 8 (T2), and week 26 (T3). Co-primary outcomes are the proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) and back pain bothersomeness (0-10 scale) at week 8. Secondary outcomes include pain intensity (NRS), global improvement, depression (PHQ-9), anxiety (GAD-7), physical activity (IPAQ-SF), sleep quality (SQS), fear-avoidance beliefs (FABQ-PA), pain catastrophizing (PCS), work productivity and activity impairment (WPAI-GH), and use of concomitant treatments. System usability scale (SUS) and patient satisfaction are assessed in the intervention group only. Safety assessments include monitoring and grading of VR-related adverse events such as dizziness, nausea, eye fatigue, headache, and falls at each contact. Randomization is performed using a computer-generated sequence with 1:1 allocation, stratified by sex and pain duration (\<2 years versus ≥2 years). Outcome assessors and statisticians are blinded to group assignment. Data management follows Good Clinical Practice (GCP) with double-entry verification and independent monitoring. This study will provide evidence for VR-MBCT as a scalable, standardized, non-pharmacological adjunctive intervention for CNLBP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Participants in the intervention group will receive an 8-week VR-based telerehabilitation program integrating mindfulness-based cognitive therapy (MBCT), pain neuroscience education (PNE), and graded exposure principles, specifically designed for chronic non-specific low back pain (CNLBP) besides usual clinical care. The program will be delivered through a VR-MR system co-developed by the research team and a technology company in Hangzhou. The system will comprise a PICO Ultra VR-MR headset for immersive mixed-reality experiences and a DM-TG01A motion capture camera for real-time tracking of participant movements and postures. All equipment will be provided to participants at no cost.
The control group will receive standard clinical care (including pharmacological treatment, physical therapy, and home exercise as usual) without any structured VR training for the initial 8-week study period. After completing the 6-month follow-up assessment, control group participants will be offered the same 8-week VR-MBCT program based on their choices.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGProportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) from baseline at Week 8
Functional disability assessed by the validated Oswestry Disability Index (ODI, score range 0-100%). Treatment responder defined as achieving a minimum clinically important improvement of ≥30% reduction from baseline at week 8.
Time frame: Baseline, Week 8
Proportion of participants achieving ≥30% improvement in self-reported back pain bothersomeness (0-10 scale) from baseline at Week 8
Back pain bothersomeness rated on a 0-10 scale (0 = no bother, 10 = worst bothersomeness). Responder defined as ≥30% score reduction from baseline at week 8.
Time frame: Baseline, Week 8
NRS Pain Intensity
Change in average pain intensity assessed by 11-point Numerical Rating Scale (NRS)
Time frame: Baseline, Week 8, Week 26
Global Pain Improvement
Global self-reported pain improvement assessed by 7-point Likert scale
Time frame: Week 8, Week 26
Anxiety (GAD-7)
Change in anxiety symptoms assessed by Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline, Week 8, Week 26
Depression (PHQ-9)
Change in depressive symptoms assessed by Patient Health Questionnaire 9-item scale (PHQ-9)
Time frame: Baseline, Week 8, Week 26
Physical Activity (IPAQ-SF)
Change in physical activity level assessed by International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: Baseline, Week 8, Week 26
Sleep Quality (SQS)
Change in overall sleep quality assessed by Single-item Sleep Quality Scale (SQS)
Time frame: Baseline, Week 8, Week 26
Fear-Avoidance Beliefs (FABQ-PA)
Change in fear-avoidance beliefs toward physical activity assessed by FABQ-PA
Time frame: Baseline, Week 8, Week 26
Pain Catastrophizing (PCS)
Change in pain catastrophizing level assessed by Pain Catastrophizing Scale(PCS)
Time frame: Baseline, Week 8, Week 26
Work Productivity (WPAI-GH)
Change in work productivity and activity impairment assessed by Work Productivity and Activity Impairment General Health (WPAI-GH)
Time frame: Baseline, Week 8, Week 26
Concomitant Treatment Use
Changes in the use of additional treatments and opioid medication for low back pain
Time frame: Baseline, Week 8, Week 26
System Usability (SUS, Intervention group only)
System usability evaluated by System Usability Scale (SUS)
Time frame: Week 8
Patient Satisfaction (Intervention group only)
Patient satisfaction and recommendation willingness rated on 0-10 scale
Time frame: Week 8
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