The comparison of pain relief efficacy of s-flurbiprofen plaster transdermal patch 20 mg at acupuncture points and transdermal patch 40 mg applied at knee in primary knee osteoarthritis: an open-label, randomized, controlled, non-inferiority trial

The faculty of medicine Siriraj hospital0 个研究点目标入组 60 人开始时间: 2024年6月16日最近更新: 2024年8月19日

适应症

试验速览

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•1. Age 50 years or older.
•2. Diagnosed with knee osteoarthritis according to the clinical classification criteria of the American College of Rheumatology, which requires the presence of knee pain and at least 3 out of the following 6 factors:
•2.1. Age over 50 years.
•2.2. Morning stiffness lasting less than 30 minutes.
•2.3. Crepitus (a grating sound or sensation) with knee movement.
•2.4. Bony tenderness around the joint.
•2.5. Bony enlargement of the joint.
•2.6. No palpable warmth in the joint.
•3. A numerical rating scale (NRS) for pain while walking between 4 and 7 out of 10, indicating moderate pain.
•4. Volunteers must be able to understand Thai through spoken, read, and written communication.

•1.History of allergy to LOCOA flurbiprofen, paracetamol, or NSAIDs.
•2. History of peptic ulcer disease, severe blood disorders, kidney disease, liver disease, severe heart disease, severe hypertension (blood pressure more than 180/110 mmHg), asthma, or aspirin-induced asthma.
•3. Currently using norfloxacin or prulifloxacin.
•4. Presence of skin wounds on the knee.
•5. History of receiving physical therapy at a hospital or knee pain relief through acupuncture within 2 weeks before volunteer screening.
•6. History of lower limb surgery within 6 months prior to volunteer screening.
•7. History of rheumatic diseases affecting the knee, such as rheumatoid arthritis or gout.
•8. Spinal or lower limb joint diseases affecting walking ability.
•9. Individuals taking medications that affect cartilage or joints.

发起方

The faculty of medicine Siriraj hospital