NCT07589790 Effect of VR-MBCT in Chronic Nonspecific Low Back Pain
| NCT ID | NCT07589790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Chronic Non-specific Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2026-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Xiaohong Jin, MD, PHD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT07589790 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying Chronic Non-specific Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07589790 currently recruiting?
Yes, NCT07589790 is actively recruiting participants. Contact the research team at jinxiaohong@suda.edu.cn for enrollment information.
Where is the NCT07589790 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07589790 clinical trial?
NCT07589790 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Xiaohong Jin, MD, PHD at The First Affiliated Hospital of Soochow University. The trial plans to enroll 214 participants.