Effect of VR-MBCT in Chronic Nonspecific Low Back Pain
Eligible age
20–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: The First Affiliated Hospital of Soochow University
You may qualify if…
- ✓ Patients who meet the following criteria will be included:
- ✓ 1. Diagnosed with CNLBP according to standard criteria (3), with pain duration ≥3 months.
- ✓ 2. Aged 20-70 years (inclusive), regardless of sex.
- ✓ 3. Average self-reported back pain bothersomeness ≥4(scale, 0-10) in the past week.
- ✓ 4. Provided informed consent and family members will be informed of the study as support persons.
You may not qualify if…
- ✕ 1. Coexisting pain conditions that may interfere with the assessment of CNLBP
- ✕ 2. Severe neurological or psychiatric disorders (e.g., unstable epilepsy, psychosis, dementia)
- ✕ 3. Severe psychiatric comorbidities (e.g., active suicidal ideation, severe depression requiring antidepressant medication)
- ✕ 4. History of substance abuse (including alcohol or drugs) in the past year
- ✕ 5. History of accidents or injuries related to back pain in the past year
- ✕ 6. Severe visual impairment, vertigo, or history of VR-induced motion sickness precluding safe VR use
- ✕ 7. Inability to communicate effectively to express subjective feelings.
Source: ClinicalTrials.gov · NCT07589790 · last updated 2026-05-15