Actively Recruiting
Effect of Virtual Reality-Based Mindfulness-Based Cognitive Therapy in Patients With Chronic Nonspecific Low Back Pain: A Multi-Center, Open-Label Randomized Controlled Trial
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-05-15
214
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
T
The Fourth Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a virtual reality-based mindfulness-based cognitive therapy (VR-MBCT) as an additional treatment for adults with chronic nonspecific low back pain (CNLBP). This multi-center, open-label, randomized controlled trial will include 214 participants aged 20 to 70 years who have had pain for at least 3 months and report significant bothersomeness. The study aims to measure improvements in disability and back pain bothersomeness after 8 weeks of intervention. Participants will be randomly assigned to one of two groups: an 8-week VR-MBCT program plus usual care, or a waitlist control group receiving usual care only during the study period. The VR-MBCT group will participate in weekly 30-minute in-clinic VR sessions and at least three home audio practice sessions each week, following a progressive curriculum designed to address cognitive and emotional aspects of pain. After the 26-week follow-up, control group participants will have the option to receive the VR-MBCT program. Throughout the study, assessments will be conducted at baseline, week 4, week 8, and week 26 to evaluate disability, pain bothersomeness, pain intensity, mood, physical activity, sleep quality, fear-avoidance beliefs, pain catastrophizing, work productivity, treatment use, usability of the VR system, and patient satisfaction. Safety monitoring will focus on VR-related adverse events like dizziness or nausea. Data analysis will follow rigorous standards to provide evidence on the role of VR-MBCT as a non-drug adjunct therapy for CNLBP.
CONDITIONS
Brief Title
Effect of VR-MBCT in Chronic Nonspecific Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic nonspecific low back pain lasting 3 months or more
- Aged between 20 and 70 years, any sex
- Average back pain bothersomeness score of 4 or higher on a 0-10 scale in the past week
- Provided informed consent with family support informed
You will not qualify if you...
- Other pain conditions that interfere with chronic nonspecific low back pain assessment
- Severe neurological or psychiatric disorders such as unstable epilepsy, psychosis, or dementia
- Severe psychiatric conditions including active suicidal thoughts or severe depression needing medication
- Substance abuse history in the past year
- Recent back pain-related accidents or injuries within the past year
- Severe visual impairment, vertigo, or VR-induced motion sickness preventing safe VR use
- Inability to communicate effectively to express subjective feelings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive an 8-week virtual reality-based mindfulness cognitive therapy program consisting of weekly in-clinic VR sessions plus multiple home-based audio practice sessions, or usual medical care without structured VR training.
1 weekly in-clinic visit plus home-based sessions at least 3 times per week
Duration - Up to 18 weeks after treatment ends
Participants complete outcome assessments and safety monitoring at weeks 4, 8, and 26 after treatment begins to evaluate pain, function, mood, physical activity, sleep, and satisfaction.
3 visits at Week 4, Week 8, and Week 26
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
X
Xiaohong Jin, MD, PHD
P
Panqi Wang, MD Candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here