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Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate | Experimental | 25mg/week orally |
|
| Placebo | Active Comparator | Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Methotrexate 25mg/week for 16 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | 4 months | |
| Pain reduction | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in physical function scores | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Abou-Raya, MD | University of Alexandria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, University of Alexandria | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D013585 | Synovitis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo |
| Drug |
Placebo tablets once a week for 16 weeks |
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |