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NCT Number: NCT07589790

Effect of VR-MBCT in Chronic Nonspecific Low Back Pain

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.

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Key information

Conditions

Chronic Non-Specific Low Back Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)

Behavioral

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.

Waitlist Usual Care Control Group

Other

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 outcomes

  1. Proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) from baseline at Week 8

    Time frame: Baseline, Week 8

    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.

  2. 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

    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.

Secondary outcomes

  1. NRS Pain Intensity

    Time frame: Baseline, Week 8, Week 26

    Change in average pain intensity assessed by 11-point Numerical Rating Scale (NRS)

  2. Global Pain Improvement

    Time frame: Week 8, Week 26

    Global self-reported pain improvement assessed by 7-point Likert scale

  3. Anxiety (GAD-7)

    Time frame: Baseline, Week 8, Week 26

    Change in anxiety symptoms assessed by Generalized Anxiety Disorder 7-item scale (GAD-7)

  4. Depression (PHQ-9)

    Time frame: Baseline, Week 8, Week 26

    Change in depressive symptoms assessed by Patient Health Questionnaire 9-item scale (PHQ-9)

  5. Physical Activity (IPAQ-SF)

    Time frame: Baseline, Week 8, Week 26

    Change in physical activity level assessed by International Physical Activity Questionnaire Short Form (IPAQ-SF)

  6. Sleep Quality (SQS)

    Time frame: Baseline, Week 8, Week 26

    Change in overall sleep quality assessed by Single-item Sleep Quality Scale (SQS)

  7. Fear-Avoidance Beliefs (FABQ-PA)

    Time frame: Baseline, Week 8, Week 26

    Change in fear-avoidance beliefs toward physical activity assessed by FABQ-PA

  8. Pain Catastrophizing (PCS)

    Time frame: Baseline, Week 8, Week 26

    Change in pain catastrophizing level assessed by Pain Catastrophizing Scale(PCS)

  9. Work Productivity (WPAI-GH)

    Time frame: Baseline, Week 8, Week 26

    Change in work productivity and activity impairment assessed by Work Productivity and Activity Impairment General Health (WPAI-GH)

  10. Concomitant Treatment Use

    Time frame: Baseline, Week 8, Week 26

    Changes in the use of additional treatments and opioid medication for low back pain

  11. System Usability (SUS, Intervention group only)

    Time frame: Week 8

    System usability evaluated by System Usability Scale (SUS)

  12. Patient Satisfaction (Intervention group only)

    Time frame: Week 8

    Patient satisfaction and recommendation willingness rated on 0-10 scale

Other outcomes

  1. Incidence and severity of VR-related adverse events

    Time frame: Immediately after each VR session, Week 4, Week 8, Week 26

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Panqi Wang, MD Candidate

CONTACT

[email protected]

+86 188 9690 3118

Xiaohong Jin, MD, PHD

CONTACT

[email protected]

+86 139 6216 3260

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Sir Run Run Shaw Hospital
  • The Fourth Affiliated Hospital of Soochow University

Registry information

Official study 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

Acronym: VR-MBCT-CNLBP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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