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.
Diagnosed with CNLBP according to standard criteria (3), with pain duration ≥3 months.
Aged 20-70 years (inclusive), regardless of sex.
Average self-reported back pain bothersomeness ≥4(scale, 0-10) in the past week.
Provided informed consent and family members will be informed of the study as support persons.
Coexisting pain conditions that may interfere with the assessment of CNLBP
Severe neurological or psychiatric disorders (e.g., unstable epilepsy, psychosis, dementia)
Severe psychiatric comorbidities (e.g., active suicidal ideation, severe depression requiring antidepressant medication)
History of substance abuse (including alcohol or drugs) in the past year
Parallel
Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)
BehavioralParticipants 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.
Waitlist Usual Care Control Group
Other interventionThe 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.
Proportion 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.
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.
NRS Pain Intensity
Change in average pain intensity assessed by 11-point Numerical Rating Scale (NRS)
Global Pain Improvement
Global self-reported pain improvement assessed by 7-point Likert scale
Anxiety (GAD-7)
Change in anxiety symptoms assessed by Generalized Anxiety Disorder 7-item scale (GAD-7)
Depression (PHQ-9)
Change in depressive symptoms assessed by Patient Health Questionnaire 9-item scale (PHQ-9)
Incidence and severity of VR-related adverse events
VR-related adverse events (including dizziness, nausea, eye strain, headache, cold sweat, and anxiety) will be actively monitored immediately after each VR training session using a 4-point severity scale (0=absent, 1=mild, 2=moderate, 3=severe). All adverse events, including non-VR-related events, will also be collected and reviewed at scheduled follow-up visits (Week 4, Week 8, Week 26).
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Soochow University
Lead sponsor
The Fourth Affiliated Hospital of Soochow University
Collaborator
Sir Run Run Shaw Hospital
Collaborator
