Effect of VR-MBCT in Chronic Nonspecific Low Back Pain

NCT07589790 | Recruiting

• 1 other identifier: 2026306
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Non-specific Low Back Pain

Keywords

Chronic low back pain; Virtual reality; Mindfulness-based cognitive therapy; Pain management

Outcome Measures

Primary Outcomes (2)

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

  Baseline, Week 8

• Proportion of participants achieving ≥30% improvement in self-reported back pain bothersomeness (0-10 scale) from baseline at 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.

  Baseline, Week 8

Secondary Outcomes (12)

• NRS Pain Intensity

  Baseline, Week 8, Week 26

• Global Pain Improvement

  Week 8, Week 26

• Anxiety (GAD-7)

  Baseline, Week 8, Week 26

• Depression (PHQ-9)

  Baseline, Week 8, Week 26

• Physical Activity (IPAQ-SF)

  Baseline, Week 8, Week 26

Other Outcomes (1)

• Incidence and severity of VR-related adverse events

  Immediately after each VR session, Week 4, Week 8, Week 26

Study Arms (2)

VR-Based Mindfulness Cognitive Therapy Intervention Group

EXPERIMENTAL

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

Waitlist Usual Care Control Group

ACTIVE COMPARATOR

Other: Waitlist Usual Care Control Group

Interventions

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.

VR-Based Mindfulness Cognitive Therapy Intervention Group

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.

Waitlist Usual Care Control Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The Fourth Affiliated Hospital of Soochow University: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaohong Jin, MD, PHD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohong Jin, MD, PHD

CONTACT

+86 139 6216 3260; jinxiaohong@suda.edu.cn

Panqi Wang, MD Candidate

CONTACT

+86 188 9690 3118; 2744237372@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group randomized controlled trial with 1:1 allocation to intervention and control arms

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)