Chronic Non-specific Low Back PainVR-MBCT-CNLBPNCT07589790
Effect of VR-MBCT in Chronic Nonspecific Low Back Pain
A study testing Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT) in people with Chronic Non-specific Low Back Pain, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaohong Jin, MD, PHD, +86 139 6216 3260, jinxiaohong@suda.edu.cn
Panqi Wang, MSc, +86 188 9690 3118, 2744237372@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT), Waitlist Usual Care Control Group
- Keywords
- Chronic low back pain, Virtual reality, Mindfulness-based cognitive therapy, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)Behavioural
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-Based Mindfulness Cognitive Therapy Intervention Group | Experimental | Not described Receives: Behavioral: Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT) |
| Waitlist Usual Care Control Group | Active comparator | Not described Receives: Other: Waitlist Usual Care Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 8
Secondary outcomes (12)
NRS Pain Intensity
Change in average pain intensity assessed by 11-point Numerical Rating Scale (NRS)
Measured: Baseline, Week 8, Week 26
Global Pain Improvement
Global self-reported pain improvement assessed by 7-point Likert scale
Measured: Week 8, Week 26
Anxiety (GAD-7)
Change in anxiety symptoms assessed by Generalized Anxiety Disorder 7-item scale (GAD-7)
Measured: Baseline, Week 8, Week 26
Depression (PHQ-9)
Change in depressive symptoms assessed by Patient Health Questionnaire 9-item scale (PHQ-9)
Measured: Baseline, Week 8, Week 26
Physical Activity (IPAQ-SF)
Change in physical activity level assessed by International Physical Activity Questionnaire Short Form (IPAQ-SF)
Measured: Baseline, Week 8, Week 26
Sleep Quality (SQS)
Change in overall sleep quality assessed by Single-item Sleep Quality Scale (SQS)
Measured: Baseline, Week 8, Week 26
Fear-Avoidance Beliefs (FABQ-PA)
Change in fear-avoidance beliefs toward physical activity assessed by FABQ-PA
Measured: Baseline, Week 8, Week 26
Pain Catastrophizing (PCS)
Change in pain catastrophizing level assessed by Pain Catastrophizing Scale(PCS)
Measured: Baseline, Week 8, Week 26
Work Productivity (WPAI-GH)
Change in work productivity and activity impairment assessed by Work Productivity and Activity Impairment General Health (WPAI-GH)
Measured: Baseline, Week 8, Week 26
Concomitant Treatment Use
Changes in the use of additional treatments and opioid medication for low back pain
Measured: Baseline, Week 8, Week 26
System Usability (SUS, Intervention group only)
System usability evaluated by System Usability Scale (SUS)
Measured: Week 8
Patient Satisfaction (Intervention group only)
Patient satisfaction and recommendation willingness rated on 0-10 scale
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group randomized controlled trial with 1:1 allocation to intervention and control arms
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Soochow University, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaohong Jin, MD, PHD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589790
- Sponsor's protocol ID
- 2026306
- Acronym
- VR-MBCT-CNLBP
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang P, Yuan J, Gu Q, Dai G, Zhu X, Liu Z, Yu Y, Jin X. Effect of virtual reality-integrated mindfulness-based cognitive therapy on pain and psychological symptoms in chronic non-specific low back pain: protocol for a randomized controlled trial. Front Digit Health. 2026 Jul 31;8:1902063. doi: 10.3389/fdgth.2026.1902063. eCollection 2026.
PubMed 42614598
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07589790
- Acronym / sponsor ID
- VR-MBCT-CNLBP / 2026306
- Conditions
- Chronic Non-specific Low Back Pain
- Keywords
- Chronic low back pain, Virtual reality, Mindfulness-based cognitive therapy, Pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Soochow University, Sir Run Run Shaw Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group randomized controlled trial with 1:1 allocation to intervention and control arms
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Behavioural | VR-Based Mindfulness Cognitive Therapy Intervention Group |
| Waitlist Usual Care Control GroupThe 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. | Other | Waitlist Usual Care Control Group |
Primary outcome
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.
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 42614598Wang P, Yuan J, Gu Q, Dai G, Zhu X, Liu Z, Yu Y, Jin X. Effect of virtual reality-integrated mindfulness-based cognitive therapy on pain and psychological symptoms in chronic non-specific low back pain: protocol for a randomized controlled trial. Front Digit Health. 2026 Jul 31;8:1902063. doi: 10.3389/fdgth.2026.1902063. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaohong Jin, MD, PHD principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT) in people with Chronic Non-specific Low Back Pain, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohong Jin, MD, PHD (+86 139 6216 3260, jinxiaohong@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) from baseline at Week 8 (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.