Rheumatoid Arthritis
Conditions
Interventions
Intervention group:vagus nerve stimulation
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Met the ACR/EULAR 2010 RA classification criteria, aged 18-75 years; Active RA, defined as: tender joint count >= 4 and swollen joint count >= 4; CRP >= 0.8 mg/dl or ESR >= 28 mm/h; Previous inadequate response/intolerance to at least one csDMARD and at least one b/tsDMARD after at least 3 months of treatment, or contraindications to b/tsDMARDs; If the patient is using glucocorticoids, the dose must have been stable for >= 1 week preoperatively and not exceed prednisone 10 mg/day or its equivalent in other glucocorticoids; If the patient is receiving csDMARD therapy, it must have been initiated at least 12 weeks before surgery, with a stable dose maintained for at least 4 weeks prior to surgery; If the patient is using NSAIDs, the dose must have been stable for >= 1 week preoperatively; Deemed eligible to undergo VNS treatment as assessed by the investigator; Agreed to participate in the study, able to cooperate with follow-up, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding patients; Patients with active infection or acute/chronic infections requiring treatment; Concomitant diagnosis of other rheumatic diseases such as systemic lupus erythematosus, psoriasis, mixed connective tissue disease, etc. (excluding secondary Sjögren's syndrome); Concomitant diagnosis of other systemic inflammatory diseases, including but not limited to juvenile chronic arthritis, inflammatory bowel disease, dermatomyositis, polymyositis, scleroderma, active vasculitis (excluding rheumatoid nodules), spondyloarthritis, psoriatic arthritis, etc.; Patients with fibromyalgia (currently with active symptoms); Patients with progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, or cerebral disorders; Patients with multiple sclerosis, Alzheimer's disease, or Parkinson's disease; Patients with a history of left or right carotid artery surgery; Patients with a history of unilateral vagotomy or partial/total splenectomy; Patients with recurrent vasovagal syncope; Patients with allergies to anesthetic agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR Response Criteria Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Activity Score in 28 Joints;Evaluator's Global Assessment;Visual Analog Scale for Pain;Clinical Disease Activity Index;Health Assessment Questionnaire - Disability Index;Patient's Global Assessment; | — |
Countries
China
Contacts
Public ContactXin Chen
Tianjin Medical University General Hospital
Outcome results
None listed