Methorexate and Knee Osteoarthritis
Study Details
Study Description
Brief Summary
Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA.
128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores.
Keywords:
methotrexate knee osteoarthritis inflammation pain reduction physical funtion
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Methotrexate 25mg oral MTX tablets |
Drug: 25 mg/week oral methotrexate tablets
Other Names:
|
Placebo Comparator: Placebo 25 mg/week placebo tablets |
Drug: 25mg/week oral placebo tablets
|
Outcome Measures
Primary Outcome Measures
- Pain reduction [8 months]
The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm).
Secondary Outcome Measures
- Physical function improvement [8 months]
Functional assessment was performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
primary knee osteoarthritis
-
synovitis
-
pain
Exclusion Criteria:
-
other inflammatory conditions
-
hepatic insufficiency
-
renal insufficiency
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Faculty of Medicine | Alexandria | Egypt | 00203 |
Sponsors and Collaborators
- University of Alexandria
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- alexmed1391963211966