Effect of VR-MBCT in Chronic Nonspecific Low Back Pain (VR-MBCT-CNLBP)
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
Přehled studie
Postavení
Detailní popis
Chronic nonspecific low back pain (CNLBP) is a leading global cause of disability, yet conventional treatments often focus on structural damage and neglect cognitive, emotional, and behavioral dimensions. Mindfulness-based cognitive therapy (MBCT) is effective for chronic pain but limited by therapist resources and low adherence. Virtual reality (VR) provides an immersive, standardized platform to improve treatment fidelity, engagement, and scalability. This multi-center randomized controlled trial investigates a tailored 8-week VR-MBCT intervention for CNLBP.
The intervention group receives a hybrid VR-MBCT program consisting of 1 weekly in-clinic VR session (approximately 30 minutes) plus at least 3 home-based audio practice sessions (20-30 minutes per session) for 8 weeks. The progressive curriculum includes automatic pilot and awareness, body scan, mindful movement, graded exposure, responding versus reacting, cognitive defusion, self-compassion, relapse prevention, self-care, and real-world transfer training. The control group receives usual medical care only during the 8-week study period and will be offered the same VR-MBCT intervention after completing the 26-week follow-up.
Outcome assessments are conducted at baseline (T0), week 4 (T1), week 8 (T2), and week 26 (T3). Co-primary outcomes are the proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) and back pain bothersomeness (0-10 scale) at week 8. Secondary outcomes include pain intensity (NRS), global improvement, depression (PHQ-9), anxiety (GAD-7), physical activity (IPAQ-SF), sleep quality (SQS), fear-avoidance beliefs (FABQ-PA), pain catastrophizing (PCS), work productivity and activity impairment (WPAI-GH), and use of concomitant treatments. System usability scale (SUS) and patient satisfaction are assessed in the intervention group only. Safety assessments include monitoring and grading of VR-related adverse events such as dizziness, nausea, eye fatigue, headache, and falls at each contact.
Randomization is performed using a computer-generated sequence with 1:1 allocation, stratified by sex and pain duration (<2 years versus ≥2 years). Outcome assessors and statisticians are blinded to group assignment. Data management follows Good Clinical Practice (GCP) with double-entry verification and independent monitoring. This study will provide evidence for VR-MBCT as a scalable, standardized, non-pharmacological adjunctive intervention for CNLBP.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Xiaohong Jin, MD, PHD
- Telefonní číslo: +86 139 6216 3260
- E-mail: jinxiaohong@suda.edu.cn
Studijní záloha kontaktů
- Jméno: Panqi Wang, MD Candidate
- Telefonní číslo: +86 188 9690 3118
- E-mail: 2744237372@qq.com
Studijní místa
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Jiangsu
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Suzhou, Jiangsu, Čína, 215006
- Nábor
- The First Affiliated Hospital of Soochow University
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Kontakt:
- Xiaohong Jin, MD, PHD
- Telefonní číslo: +86 139 6216 3260
- E-mail: jinxiaohong@suda.edu.cn
-
Kontakt:
- Panqi Wang, MSc
- Telefonní číslo: +86 188 9690 3118
- E-mail: 2744237372@qq.com
-
Vrchní vyšetřovatel:
- Xiaohong Jin, MD, PHD
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Dílčí vyšetřovatel:
- Panqi Wang, MSc
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: VR-Based Mindfulness Cognitive Therapy Intervention Group
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Participants in the intervention group will receive an 8-week VR-based telerehabilitation program integrating mindfulness-based cognitive therapy (MBCT), pain neuroscience education (PNE), and graded exposure principles, specifically designed for chronic non-specific low back pain (CNLBP) besides usual clinical care.
The program will be delivered through a VR-MR system co-developed by the research team and a technology company in Hangzhou.
The system will comprise a PICO Ultra VR-MR headset for immersive mixed-reality experiences and a DM-TG01A motion capture camera for real-time tracking of participant movements and postures.
All equipment will be provided to participants at no cost.
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Aktivní komparátor: Waitlist Usual Care Control Group
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The control group will receive standard clinical care (including pharmacological treatment, physical therapy, and home exercise as usual) without any structured VR training for the initial 8-week study period.
After completing the 6-month follow-up assessment, control group participants will be offered the same 8-week VR-MBCT program based on their choices.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) from baseline at Week 8
Časové okno: Baseline, Week 8
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Functional disability assessed by the validated Oswestry Disability Index (ODI, score range 0-100%).
Treatment responder defined as achieving a minimum clinically important improvement of ≥30% reduction from baseline at week 8.
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Baseline, Week 8
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Proportion of participants achieving ≥30% improvement in self-reported back pain bothersomeness (0-10 scale) from baseline at Week 8
Časové okno: Baseline, Week 8
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Back pain bothersomeness rated on a 0-10 scale (0 = no bother, 10 = worst bothersomeness).
Responder defined as ≥30% score reduction from baseline at week 8.
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Baseline, Week 8
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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NRS Pain Intensity
Časové okno: Baseline, Week 8, Week 26
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Change in average pain intensity assessed by 11-point Numerical Rating Scale (NRS)
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Baseline, Week 8, Week 26
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Global Pain Improvement
Časové okno: Week 8, Week 26
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Global self-reported pain improvement assessed by 7-point Likert scale
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Week 8, Week 26
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Anxiety (GAD-7)
Časové okno: Baseline, Week 8, Week 26
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Change in anxiety symptoms assessed by Generalized Anxiety Disorder 7-item scale (GAD-7)
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Baseline, Week 8, Week 26
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Depression (PHQ-9)
Časové okno: Baseline, Week 8, Week 26
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Change in depressive symptoms assessed by Patient Health Questionnaire 9-item scale (PHQ-9)
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Baseline, Week 8, Week 26
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Physical Activity (IPAQ-SF)
Časové okno: Baseline, Week 8, Week 26
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Change in physical activity level assessed by International Physical Activity Questionnaire Short Form (IPAQ-SF)
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Baseline, Week 8, Week 26
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Sleep Quality (SQS)
Časové okno: Baseline, Week 8, Week 26
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Change in overall sleep quality assessed by Single-item Sleep Quality Scale (SQS)
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Baseline, Week 8, Week 26
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Fear-Avoidance Beliefs (FABQ-PA)
Časové okno: Baseline, Week 8, Week 26
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Change in fear-avoidance beliefs toward physical activity assessed by FABQ-PA
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Baseline, Week 8, Week 26
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Pain Catastrophizing (PCS)
Časové okno: Baseline, Week 8, Week 26
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Change in pain catastrophizing level assessed by Pain Catastrophizing Scale(PCS)
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Baseline, Week 8, Week 26
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Work Productivity (WPAI-GH)
Časové okno: Baseline, Week 8, Week 26
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Change in work productivity and activity impairment assessed by Work Productivity and Activity Impairment General Health (WPAI-GH)
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Baseline, Week 8, Week 26
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Concomitant Treatment Use
Časové okno: Baseline, Week 8, Week 26
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Changes in the use of additional treatments and opioid medication for low back pain
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Baseline, Week 8, Week 26
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System Usability (SUS, Intervention group only)
Časové okno: Week 8
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System usability evaluated by System Usability Scale (SUS)
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Week 8
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Patient Satisfaction (Intervention group only)
Časové okno: Week 8
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Patient satisfaction and recommendation willingness rated on 0-10 scale
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Week 8
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence and severity of VR-related adverse events
Časové okno: Immediately after each VR session, Week 4, Week 8, Week 26
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VR-related adverse events (including dizziness, nausea, eye strain, headache, cold sweat, and anxiety) will be actively monitored immediately after each VR training session using a 4-point severity scale (0=absent, 1=mild, 2=moderate, 3=severe).
All adverse events, including non-VR-related events, will also be collected and reviewed at scheduled follow-up visits (Week 4, Week 8, Week 26).
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Immediately after each VR session, Week 4, Week 8, Week 26
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Xiaohong Jin, MD, PHD, The First Affiliated Hospital of Soochow University
Termíny studijních záznamů
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