Role of Methotrexate in Ultrasound Proven Synovitis in Patients With Knee Osteoarthritis: A Randomized Controlled Trial

What this Trial Is About

Osteoarthritis (OA) of the knee is a common cause of disability, often involving complex changes in the joint including synovitis, which is linked to pain. Researchers are evaluating methotrexate (MTX), a drug known to treat synovitis in other arthritis types, for its potential to reduce synovitis and relieve pain in patients with primary knee OA confirmed by ultrasound. This randomized controlled trial aims to assess the role of MTX in knee OA with ultrasound-proven synovitis. The trial will enroll 70 patients aged 40 to 70 years who meet specific clinical and radiological criteria for knee OA, including knee pain and ultrasound-detected synovitis. Participants will be randomly assigned to receive either MTX, starting at 15 mg per week and increasing to 20 mg if tolerated, or a placebo. Both groups may use NSAIDs as needed and follow standard non-pharmacological treatments for OA. The study will last for 6 months, with assessments at 3 and 6 months. During the study, pain and function will be measured using the WOMAC index and visual analog scale, while quality of life will be assessed with the SF-12 survey. Ultrasound exams will be performed to evaluate synovitis changes. Adverse effects will be monitored through medical history, exams, and tests. The trial uses a double-blinded design, and data analysis will include statistical tests to compare outcomes between groups. Participants can withdraw at any time, and confidentiality will be maintained throughout the study.

Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA