[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":62,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VR-Based Mindfulness Cognitive Therapy Intervention Group","EXPERIMENTAL",null,[13],"Behavioral: Virtual Reality-Based Mindfulness Cognitive Therapy (VR-MBCT)",{"label":15,"type":16,"description":11,"interventionNames":17},"Waitlist Usual Care Control Group","ACTIVE_COMPARATOR",[18],"Other: Waitlist Usual Care Control Group",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"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 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.",[9],{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"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.",[15],[29],{"name":30,"affiliation":5,"role":31},"Xiaohong Jin, MD, PHD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","+86 139 6216 3260","jinxiaohong@suda.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":11,"email":40},"Panqi Wang, MD Candidate","+86 188 9690 3118","2744237372@qq.com",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Suzhou","Jiangsu","215006","China","CN",{"type":50,"coordinates":51},"Point",[52,53],120.59538,31.30408,{"lat":53,"lon":52},[56,57,59,60],{"name":30,"role":34,"phone":35,"phoneExt":11,"email":36},{"name":58,"role":34,"phone":39,"phoneExt":11,"email":40},"Panqi Wang, MSc",{"name":30,"role":31,"phone":11,"phoneExt":11,"email":11},{"name":58,"role":61,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[65,67],{"name":66,"class":6},"The Fourth Affiliated Hospital of Soochow University",{"name":68,"class":6},"Sir Run Run Shaw Hospital","100640542","effect-of-vr-mbct-in-chronic-nonspecific-low-back-pain-100640542",false,"NCT07589790","Effect of VR-MBCT in Chronic Nonspecific Low Back Pain","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","VR-MBCT-CNLBP","Inclusion Criteria:\n\nPatients who meet the following criteria will be included:\n\n1. Diagnosed with CNLBP according to standard criteria (3), with pain duration ≥3 months.\n2. Aged 20-70 years (inclusive), regardless of sex.\n3. Average self-reported back pain bothersomeness ≥4(scale, 0-10) in the past week.\n4. Provided informed consent and family members will be informed of the study as support persons.\n\nExclusion Criteria:\n\n1. Coexisting pain conditions that may interfere with the assessment of CNLBP\n2. Severe neurological or psychiatric disorders (e.g., unstable epilepsy, psychosis, dementia)\n3. Severe psychiatric comorbidities (e.g., active suicidal ideation, severe depression requiring antidepressant medication)\n4. History of substance abuse (including alcohol or drugs) in the past year\n5. History of accidents or injuries related to back pain in the past year\n6. Severe visual impairment, vertigo, or history of VR-induced motion sickness precluding safe VR use\n7. Inability to communicate effectively to express subjective feelings.","ALL","20 Years","70 Years",{"count":81,"type":82},214,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.",[88],"Chronic Non-specific Low Back Pain",[90,91,92,93],"Chronic low back pain","Virtual reality","Mindfulness-based cognitive therapy","Pain management","2026-05-10",{"date":96,"type":97},"2026-05-15","ACTUAL",{"date":99,"type":97},"2026-04-01",{"date":101,"type":82},"2027-04-01",{"name":5,"class":6},1]