VR-MBCT for chronic nonspecific low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial compares an 8-week virtual reality-based mindfulness-based cognitive therapy (VR-MBCT) plus usual care to waitlist usual care in adults with chronic nonspecific low back pain. Participants (n=214) aged 20–70 with pain lasting at least 3 months and a pain bothersomeness score of 4 or higher will be randomized 1:1 to VR-MBCT or waitlist control, with assessments at baseline, week 4, week 8, and week 26. The co-primary outcomes are the proportion achieving ≥30% improvement in Oswestry Disability Index and back pain bothersomeness at week 8; secondary outcomes include anxiety, depression, sleep, physical activity, fear-avoidance beliefs, catastrophizing, work productivity, and other measures of pain and function. The VR-MBCT program combines weekly in-clinic sessions with home practice over 8 weeks, featuring a structured mindfulness and cognitive therapy curriculum delivered via VR and audio sessions. After 26 weeks, the control group will be offered the VR-MBCT intervention. Safety and adherence are monitored throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xiaohong Jin, MD, PHD — The First Affiliated Hospital of Soochow University
• Study coordinator: Xiaohong Jin, MD, PHD
• Email: jinxiaohong@suda.edu.cn
• Phone: +86 139 6216 3260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.