Effect of VR-MBCT in Chronic Nonspecific Low Back Pain

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) from baseline at Week 8 [Time frame: Baseline, Week 8]
• Proportion of participants achieving ≥30% improvement in self-reported back pain bothersomeness (0-10 scale) from baseline at Week 8 [Time frame: Baseline, Week 8]

Secondary outcome measures (12)

• NRS Pain Intensity [Time frame: Baseline, Week 8, Week 26]
• Global Pain Improvement [Time frame: Week 8, Week 26]
• Anxiety (GAD-7) [Time frame: Baseline, Week 8, Week 26]
• Depression (PHQ-9) [Time frame: Baseline, Week 8, Week 26]
• Physical Activity (IPAQ-SF) [Time frame: Baseline, Week 8, Week 26]
• Sleep Quality (SQS) [Time frame: Baseline, Week 8, Week 26]
• Fear-Avoidance Beliefs (FABQ-PA) [Time frame: Baseline, Week 8, Week 26]
• Pain Catastrophizing (PCS) [Time frame: Baseline, Week 8, Week 26]
• Work Productivity (WPAI-GH) [Time frame: Baseline, Week 8, Week 26]
• Concomitant Treatment Use [Time frame: Baseline, Week 8, Week 26]
• System Usability (SUS, Intervention group only) [Time frame: Week 8]
• Patient Satisfaction (Intervention group only) [Time frame: Week 8]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07589790 · 2026306

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗