Rheumatoid Arthritis (RA)taVNS for PainNCT07870564
the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis
A study testing taVNS in people with Rheumatoid Arthritis (RA) and Transcutaneous Vagus Nerve Stimulation, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA), Transcutaneous Vagus Nerve Stimulation
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2029
- Phase
- Interventional
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Being tested
- taVNS, Sham Stimulation
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
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.
Sham StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: taVNS |
| 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. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, Week 4 (end of treatment), and Week 8 (follow-up)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Sichuan Province Orthopetic Hospital, Inner Mongolia Hospital of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Shenzhen traditional Chinese medical hospital, Centre Hospitalier Universitaire de Saint Etienne
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870564
- Sponsor's protocol ID
- 2026-150-KY-01
- Acronym
- taVNS for Pain
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No