Primary Sjögren's Syndrome
Conditions
Interventions
Intervention Group:Verum Acupuncture
Control Group:Sham Acupuncture
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the 2016 International Classification (Diagnostic) Criteria for pSS; (2) Fulfill the diagnostic criteria for pSS-associated peripheral neuropathy (PNS); (3) Have moderate to severe pSS-associated PNS, defined as symptoms such as numbness, tingling, or pain with a score =4 on the Numerical Rating Scale (NRS); (4) Age =18 years; (5) Provide signed informed consent and demonstrate willingness to participate in the trial.
Exclusion criteria
Exclusion criteria: (1) Diagnosis of secondary Sjögren's syndrome resulting from other diffuse connective tissue diseases or autoimmune disorders, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatomyositis/polymyositis (DM/PM), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), etc. (2) Peripheral neuropathy potentially caused by hereditary disorders or other etiologies, including paraneoplastic syndrome, alcoholism, vitamin B12 deficiency, diabetes mellitus, drug-induced neuropathy, systemic vasculitis unrelated to pSS, hypothyroidism, amyloidosis, paraproteinemia, etc. (3) Severe comorbidities affecting major organs (e.g., cardiovascular, cerebral, hepatic, pulmonary, renal, or hematopoietic systems), acute or chronic infectious diseases, malignant tumors, or psychiatric disorders. (4) Pregnancy, lactation, or plans to become pregnant within the next 12 months. (5) Cognitive impairment leading to inability to comprehend assessment scales or provide accurate data. (6) Receipt of glucocorticoid pulse therapy, cyclophosphamide pulse therapy, intravenous immunoglobulin, or rituximab treatment within 30 days, or current unstable medication regimen. (7) Concurrent use of medications specifically for preventing or treating neuropathy. (8) History of needle fainting (syncope related to acupuncture).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale,NRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| EULAR Sjögren's Syndrome Disease Activity Index,ESSDAI;Neurological Symptom Score,NSS;EULAR Sjögren's Syndrome Patient Reported Index,ESSPRI;Short Form Health Survey-36,SF-36;IgA IgM IgG RF C3 C4,CRP ESR; | — |
Countries
china
Contacts
Public ContactLiu Jia Meng Jiang Quan
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed