the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
With
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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis
