An interventional study of taVNS and Sham Stimulation in Rheumatoid Arthritis (RA) and Transcutaneous Vagus Nerve Stimulation, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's planned enrollment of 124 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 136 studies on the registry; 37 are open to participants now.
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① Meeting the 2010 ACR/EULAR 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 \<90 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.
Exclusion Criteria:
① 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.
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.
Device: taVNS
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.
Device: Sham Stimulation
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.
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.
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
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
ACR20/50/70 response criteria
The ACR20/50/70 response criteria are consensus-defined outcome metrics to judge clinical treatment response in patients with rheumatoid arthritis.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)]
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.
Time frame: baseline
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Plan to share: No
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences →