[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659832":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":62,"studyPopulation":62,"armGroups":70,"interventions":83,"overallOfficials":62,"centralContacts":93,"locations":62,"responsibleParty":99,"collaborators":103,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":62,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":62,"overallStatus":144,"whyStopped":62,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":62},{"fullName":5,"class":6},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in Central Sensitization Inventory-9 (CSI-9) score at Week 4 of treatment.","The Central Sensitization Inventory-9 (CSI-9), a 9-item short-form self-report questionnaire derived from CSI-25, is used to assess symptoms of central sensitization in patients with chronic pain","baseline, Week 4 (end of treatment), and Week 8 (follow-up)",[14,17,20,23,26,29,32,35,38,41,44,47,50],{"measure":15,"description":16,"timeFrame":12},"Visual Analogue Scale (VAS) for pain","The Visual Analogue Scale (VAS) for pain is a widely-used self-reported unidimensional tool to quantify the subjective intensity of clinical pain.",{"measure":18,"description":19,"timeFrame":12},"Polysymptomatic Distress Scale (PDS)","The Polysymptomatic Distress Scale (PDS) evaluates widespread somatic symptom burden and is commonly applied for screening and assessing fibromyalgia-related symptomatology.",{"measure":21,"description":22,"timeFrame":12},"Brief Pain Inventory (BPI)","The Brief Pain Inventory (BPI) is a validated questionnaire measuring pain severity and pain-related interference with daily function in patients with chronic pain conditions.",{"measure":24,"description":25,"timeFrame":12},"Fibromyalgia Impact Questionnaire-Revised (FIQR)","The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses overall disease impact including physical function, symptoms and quality of life among patients with fibromyalgia-like chronic pai",{"measure":27,"description":28,"timeFrame":12},"Multidimensional Fatigue Inventory-20 (MFI-20)","The Multidimensional Fatigue Inventory-20 (MFI-20) is a 20-item self-report instrument that evaluates multiple dimensions of fatigue in chronic disease populations.",{"measure":30,"description":31,"timeFrame":12},"Pittsburgh Sleep Quality Index (PSQI)","The Pittsburgh Sleep Quality Index (PSQI) is a well-validated questionnaire for comprehensively assessing subjective sleep quality and sleep disturbances over the past month.",{"measure":33,"description":34,"timeFrame":12},"Hospital Anxiety and Depression Scale (HAD)","The Hospital Anxiety and Depression Scale (HAD) screens for symptoms of anxiety and depression in physically-ill patient populations without emphasis on somatic complaints.",{"measure":36,"description":37,"timeFrame":12},"12-Item Short Form Health Survey (SF-12)","The 12-Item Short Form Health Survey (SF-12) is a concise generic tool measuring physical and mental health-related quality of life.",{"measure":39,"description":40,"timeFrame":12},"Composite Autonomic Symptom Score 31 (COMPASS-31)","The Composite Autonomic Symptom Score 31 (COMPASS-31) is a self-administered questionnaire used to evaluate the overall burden of diverse autonomic dysfunction symptoms.",{"measure":42,"description":43,"timeFrame":12},"Disease Activity Score in 28 joints-ESR (DAS28-ESR)","The Disease Activity Score in 28 joints-ESR (DAS28-ESR) is a standard composite index quantifying inflammatory disease activity in patients with rheumatoid arthritis.",{"measure":45,"description":46,"timeFrame":12},"ACR20\u002F50\u002F70 response criteria","The ACR20\u002F50\u002F70 response criteria are consensus-defined outcome metrics to judge clinical treatment response in patients with rheumatoid arthritis.",{"measure":48,"description":49,"timeFrame":12},"Health Assessment Questionnaire (HAQ)","The Health Assessment Questionnaire (HAQ) is a classic instrument for evaluating physical functional disability in individuals with rheumatic diseases such as rheumatoid arthritis.",{"measure":51,"description":52,"timeFrame":53},"morning stiffness duration","Morning stiffness duration is a core clinical clinical marker reflecting inflammatory status, recorded as the length of joint-related stiffness after waking in rheumatoid arthritis patients.","baseline, Week 4 (end of treatment), and Week 8 (follow-up)]",[55],{"measure":56,"description":57,"timeFrame":58},"Semi-Quantitative Food Frequency Questionnaire (SFFQ)","The Semi-Quantitative Food Frequency Questionnaire (SFFQ) captures habitual dietary intake and food consumption frequency for nutritional and epidemiological research.","baseline",{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":62,"timePerspective":62,"maskingInfo":64},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":65,"maskingDescription":62,"whoMasked":66},"TRIPLE",[67,68,69],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Experimental group","EXPERIMENTAL","Hua Tuo electronic acupuncture device (Model SDZ-IIB), real auricular clips with electrodes placed bilaterally at the cavum conchae and cymba conchae; dense-disperse wave at 25 Hz, intensity set to the maximum tolerable level without pain.Twice daily, 30 minutes per session, 5 consecutive days per week, for 4 weeks total.",[76],"Device: taVNS",{"label":78,"type":79,"description":80,"interventionNames":81},"Control group","SHAM_COMPARATOR","identical device with sham auricular clips; electrodes are placed bilaterally on the auricular scapha; all operational parameters match the experimental group. Both groups are informed that mild electrical sensations may occur.Twice daily, 30 minutes per session, 5 consecutive days per week, for 4 weeks total.",[82],"Device: Sham Stimulation",[84,89],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":62},"DEVICE","taVNS","Treatment using the Huatuo electronic acupuncture device (model SDZ-IIB) with electrodes placed on the auricular points related to the heart and kidney. Pulsed wave type is sparse-dense wave, with a frequency of 20Hz and intensity set to the highest level tolerable without pain. Patients will perform self-treatment at home for 30 minutes, twice daily, for 5 days a week over 4 weeks.",[72],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":62},"Sham Stimulation","Treatment using the same Huatuo electronic acupuncture device with electrodes placed on different ear points (over the ear helix). The device settings (pulse type, frequency, intensity) are the same as the experimental group but do not correspond to traditional acupuncture points. Patients will also perform self-treatment at home as per the same schedule as the experimental group.",[78],[94],{"name":95,"role":96,"phone":97,"phoneExt":62,"email":98},"juan jiao","CONTACT","01088001030","jiao.juan@hotmail.com",{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"PRINCIPAL_INVESTIGATOR","Juan Jiao","Chief Physician",[104,106,108,110,112,115,117,119,121],{"name":105,"class":6},"Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine",{"name":107,"class":6},"Affiliated Hospital of Shandong University of Traditional Chinese Medicine",{"name":109,"class":6},"The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine",{"name":111,"class":6},"Sichuan Province Orthopetic Hospital",{"name":113,"class":114},"Inner Mongolia Hospital of Traditional Chinese Medicine","UNKNOWN",{"name":116,"class":6},"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine",{"name":118,"class":6},"The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine",{"name":120,"class":114},"Shenzhen traditional Chinese medical hospital",{"name":122,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","100659832","study-on-the-effect-and-mechanism-of-percutaneous-auricular-electrical-stimulation-in-preventing-central-sensitization-pain-in-comorbid-rheumatoid-arthritis-100659832",false,"NCT07870564","Study on the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Comorbid Rheumatoid Arthritis","Evaluation of the Effectiveness and Mechanism of Traditional Chinese Medicine in Preventing Central Sensitization Pain in Rheumatoid Arthritis Based on Real-World Cohorts - Study on the Effect and Mechanism of Transcutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain Associated With Rheumatoid Arthritis","taVNS for Pain","Inclusion Criteria:\n\n① Meeting the 2010 ACR\u002FEULAR classification criteria for RA;② Central Sensitization Inventory-9 (CSI-9) score ≥18 points;③ Aged 18-75 years, regardless of gender;④ Visual Analogue Scale (VAS) pain score ≥40 mm and \\\u003C90 mm at screening and randomization; subjects must complete a daily VAS pain diary for 7 consecutive days prior to randomization, with at least 4 valid records and an average daily VAS pain score ≥40 mm across valid days;⑤ Stable dosage and regimen of glucocorticoids, DMARDs, biologic agents and other basic immunotherapies for 4 weeks before enrolment, with no planned adjustments during the study;⑥ Stable dosage and regimen of analgesics (NSAIDs, pregabalin, gabapentin, etc.) for 4 weeks before enrolment, with no planned adjustments during the study;⑦ No oral Chinese herbal medicine initiated during the study, or stable oral Chinese herbal medicine for ≥4 weeks before enrolment with no planned prescription modification throughout the study;⑧ Voluntary participation in this study.\n\nExclusion Criteria:\n\n① Satisfying the 2016 revised ACR classification criteria for fibromyalgia syndrome at assessment;② Prior diagnosis of fibromyalgia syndrome by a rheumatology-immunology department;③ Neuropathic Pain Screening Questionnaire score ≥13 points suggestive of neuropathic pain;④ Pain caused by trauma, infection, malignancy, nerve entrapment, acute gout attack or other etiologies;⑤ Severe primary diseases of the heart, liver, kidney or hematopoietic system, or severe psychiatric disorders interfering with assessment compliance;⑥ Auricular lesions including lacerations, inflammation, eczema, chilblain, contraindicating taVNS;⑦ History of unilateral or bilateral vagotomy, or recurrent vasovagal syncope;⑧ Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":135,"type":136},124,"ESTIMATED","INTERVENTIONAL",[139],"NA","This multicenter, randomized, double-blind, sham-controlled trial aimed to evaluate the preventive efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) against central-sensitization-related pain in high-risk rheumatoid arthritis (RA) patients. A total of 124 eligible participants were randomized 1:1 to receive 4-week home-based real or sham taVNS. The primary outcome was the change in Central Sensitization Inventory-9 (CSI-9) score from baseline to week 4. Peripheral blood, faecal samples and brain MRI were collected to explore potential brain-gut-microbiome-related mechanisms. Our findings will provide high-quality evidence for this non-pharmacological intervention for RA-related central sensitization pain.",[142,143],"Rheumatoid Arthritis (RA)","Transcutaneous Vagus Nerve Stimulation","NOT_YET_RECRUITING","2026-10-06",{"date":147,"type":148},"2026-10-13","ACTUAL",{"date":150,"type":136},"2026-10-01",{"date":152,"type":136},"2029-10-01",{"name":5,"class":6}]