rheumatoid arthritis
Conditions
Interventions
Positive drug control group:Methotrexate (MTX)
Acupuncture knife treatment group:Combination of methotrexate and needle-knife therapy
Sponsors
Gansu Provincial Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria Participants must meet all of the following conditions to be enrolled: (1)Fulfill the diagnostic criteria for rheumatoid arthritis (RA); (2)Age between 18 and 60 years, regardless of sex; (3)Moderate to severe disease activity, defined as DAS28-ESR > 3.2; (4)Disease duration = 6 months; (5)No prior use of biologic agents, or discontinued biologic therapy for = 3 months; (6)Radiographic (X-ray or MRI) evidence of bone erosion in the wrist, metacarpophalangeal, or proximal interphalangeal joints, with a Sharp score = 1; (7)Receiving a stable dose of disease-modifying antirheumatic drugs (DMARDs, e.g., methotrexate) for = 3 months, with no planned dose adjustment; (8)Able to undergo needle-knife therapy and not requiring emergency surgical intervention; (9)Willing to participate voluntarily and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Participants meeting any of the following conditions will be excluded: (1) Presence of other autoimmune diseases such as systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis, systemic sclerosis, or other immune system disorders, as well as severe infectious diseases; (2) Concomitant severe primary diseases (e.g., cardiovascular, hepatic, or renal insufficiency), psychiatric disorders, or other serious conditions affecting survival; (3) Receipt of intra-articular glucocorticoid injection or systemic glucocorticoid therapy (prednisone >10 mg/day for more than 2 weeks) within the past 6 months; (4) Coagulation disorders, local skin infection, or contraindications to acupuncture/needle therapy; (5) Severe osteoporosis, history of fracture, malignancy, or major surgery within the past year; (6) Pregnancy, planned pregnancy during the study period, or lactation; (7) Participation in another clinical trial within the past 3 months or concurrent participation in another trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the proportion of patients meeting the ACR response criteria;DAS28 score;Visual Analog Scale (VAS) score for pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| BGP;BUN;Anti-cyclic citrullinated peptide antibody;AST;CRP;PLT;IL-6;RF;Sharp score;MMP3;BAP;ALT;Health Assessment Questionnaire (HAQ);Joint ultrasound score;Clinical Disease Activity Index (CDAI);Protein in the urine;Cr;CTX-1;WBC;TBIL;PINP;ESR; | — |
Countries
China
Contacts
Public ContactWANG Haidong
Gansu Provincial Traditional Chinese Medicine Hospital
Outcome results
None listed