Effect of VR-MBCT in Chronic Nonspecific Low Back Pain

Recruiting now · Not applicable

Conditions studied: Chronic Non-specific Low Back Pain

In brief

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.

Key facts

Study ID: NCT07589790
Run by: The First Affiliated Hospital of Soochow University
People needed: 214
Starts: 2026-04-01
Expected to finish: 2027-04-01
Last updated by the study team: 2026-05-15

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients who meet the following criteria will be included:
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.

You may not qualify if…

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
History of accidents or injuries related to back pain in the past year
Severe visual impairment, vertigo, or history of VR-induced motion sickness precluding safe VR use
Inability to communicate effectively to express subjective feelings.

Where it is running

The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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