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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07870564
- Acronym / sponsor ID
- taVNS for Pain / 2026-150-KY-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, 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
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 13 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: taVNSHua 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. |
| Control group | Sham comparator | Device: Sham Stimulationidentical 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| taVNSTreatment 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. | Device | Experimental group |
| Sham StimulationTreatment 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. | Device | Control group |
Primary outcome
Change from baseline in Central Sensitization Inventory-9 (CSI-9) score at Week 4 of treatment.
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
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
13 secondary outcomes
Visual Analogue Scale (VAS) for pain
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Polysymptomatic Distress Scale (PDS)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Brief Pain Inventory (BPI)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Fibromyalgia Impact Questionnaire-Revised (FIQR)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Multidimensional Fatigue Inventory-20 (MFI-20)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Hospital Anxiety and Depression Scale (HAD)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
12-Item Short Form Health Survey (SF-12)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Composite Autonomic Symptom Score 31 (COMPASS-31)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Disease Activity Score in 28 joints-ESR (DAS28-ESR)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
ACR20/50/70 response criteria
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Health Assessment Questionnaire (HAQ)
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)
morning stiffness duration
Time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)]
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 Oct 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.
Questions about this trial
What is this clinical trial studying?
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.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 juan jiao (01088001030, jiao.juan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Central Sensitization Inventory-9 (CSI-9) score at Week 4 of treatment. (time frame: baseline, Week 4 (end of treatment), and Week 8 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.