Effect of VR-MBCT in Chronic Nonspecific Low Back Pain
RecruitingNot applicableNCT07589790
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of Virtual Reality-Based Mindfulness-Based Cognitive Therapy in Patients With Chronic Nonspecific Low Back Pain: Protocol for a Prospective, Multi-Center, Open-Label Randomized Controlled Trial
- Conditions
- Interventions
- Behavioral: Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)
- Other: Waitlist Usual Care Control Group
- Sponsor
- The First Affiliated Hospital of Soochow University
- Collaborators
- The Fourth Affiliated Hospital of Soochow University; Sir Run Run Shaw Hospital
- Start date
- 2026-04-01
- Primary completion
- 2027-04-01
- Sex
- All
- Age range
- from 20 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07589790