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Effect of VR-MBCT in Chronic Nonspecific Low Back Pain

RecruitingNAAges 20 Years - 70 YearsAllThe First Affiliated Hospital of Soochow Universi…
NCT07589790 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 belie

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📋 Eligibility rules (as published)
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.
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What it tests

  • Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)
  • Waitlist Usual Care Control Group
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Where

1 site
The First Affiliated Hospital of Soochow University
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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