rheumatoid arthritis
Conditions
Interventions
control group:Drug treatment combined with acupuncture treatment
Treatment group:Drug treatment combined meridian-Sinew Release therapy
Sponsors
Department of Chinese Medicine and Rheumatology, General Hospital of Southern Theatre Command, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants, aged between 18 and 75 years; 2. Diagnosis based on the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria; 3. Active disease state (DAS-28 > 2.6) with at least one knee joint showing both swelling and significant effusion; 4. Participants must have been on oral methotrexate (MTX) treatment for at least 12 weeks prior to randomization with a stable dose (ranging from 7.5 to 25 mg/week) for at least 4 weeks. Those with a history of parenteral MTX use (subcutaneous, intramuscular, or intravenous) are eligible, but must have been on a stable oral dose of MTX 7.5-25 mg/week for at least 4 weeks before randomization; 5. At screening, participants using nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids must meet the following requirements: - NSAIDs dosage must be stable for at least 2 weeks prior to the first administration; - Oral corticosteroids (equivalent to <=10 mg/day of prednisone) or inhaled corticosteroids must have been at a stable dose for at least 4 weeks prior to the first administration; 6. Participants must discontinue all opioid medications at least one week before the first administration; 7. Participants must voluntarily participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Advanced-stage patients with severe joint deformities, joint function grade IV, radiographic stage IV, and significant skin lesions or ulcers at the affected joint sites; 2. Candidates who meet the inclusion criteria but have coexisting rheumatic autoimmune diseases; concurrent fractures, severe infections, tumors, infectious skin diseases; severe cardiovascular or cerebrovascular diseases, abnormal liver or kidney function, hematologic disorders, diabetic peripheral neuropathy; cognitive impairments, communication barriers, psychiatric disorders; HIV infection or other immunodeficiencies; 3. Individuals allergic to any drugs used during the Meridian-Sinew Release Therapy procedure, those with needle phobia, or others who cannot undergo Meridian-Sinew Release Therapy for various reasons; 4. Pregnant or breastfeeding women; 5. Fertile male or female participants who do not agree to use medically accepted contraceptive methods during the study period and for at least six months after the last administration of the study drug; 6. Individuals who have used biologic DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) within the past three months; 7. Participants undergoing other local treatments concurrently, or who have received other local therapies within one month prior to the start of the trial, or who have been involved in other interventional clinical trials within the past month. 8. Individuals whom the researcher deems unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity score in 28 joints (DAS-28); | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale/Score (VAS);The Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL);Infrared thermal imaging of knee joint;Erythrocyte sedimentation rate (ESR);C-reactive protein;Rheumatoid factor;Anti-cyclic citrullinated peptide antibody;Systemic Immune-Inflammation Index (SII) and other novel inflammatory indicators;Expression of JAK1 and STAT3 proteins, phosphorylation levels of p-JAK1 and p-STAT3, and expression of SOCS1 protein in knee joint fluid (either synovial fluid alone or including lavage fluid) along the JAK-STAT signaling pathway;Levels of inflammatory markers (such as TNF-a and IL-6) in knee joint fluid (either synovial fluid alone or including lavage fluid); | — |
Countries
China
Contacts
Public ContactZhihuang Chen
Department of Chinese Medicine and Rheumatology, General Hospital of Southern Theatre Command, PLA
Outcome results
None listed