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

Prior treatment

• 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.

• 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.