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the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis

NCT ID: NCT07870564
Registry status: Not yet recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions: Rheumatoid Arthritis (RA), Transcutaneous Vagus Nerve Stimulation

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 124 participants (Estimated).

What is being studied

Device: Sham Stimulation
Device: taVNS

Who may be eligible

Ages: 18 Years to 75 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 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.

Study locations

No study locations are listed in the registry data.

Study details

Start date: October 1, 2026
Primary completion date: October 1, 2029
Completion date: October 1, 2029
First posted: October 13, 2026
Collaborators: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Centre Hospitalier Universitaire de Saint Etienne, Inner Mongolia Hospital of Traditional Chinese Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shenzhen traditional Chinese medical hospital, Sichuan Province Orthopetic Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07870564
Registry last updated: October 15, 2026
QualifiedStudies registry data refreshed: October 19, 2026
QualifiedStudies record fetched: October 19, 2026

View NCT07870564 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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