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

Phase 4

• Conditions: Osteoarthritis of knee; S-flurbiprofen plaster; Acupuncture points; Pain

• Registration Number: TCTR20240616003
• Lead Sponsor: The faculty of medicine Siriraj hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-16
• Last Update Posted: 19 August 2024
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain severity The results will be measured at three time points: 1. 1 week after starting the medication. 2. 2 weeks after starting the medication. 3. 4 weeks after starting the medication. Numerical rating scale

Secondary Outcome Measures

Name	Time	Method
The effectiveness in terms of physical function The results will be assessed at two time points: 1. 2 weeks after starting the medication. 2. 4 weeks after starting the medication. Knee Injury and Osteoarthritic Outcome Score (KOOS),The effectiveness in terms of physical function The results will be assessed at two time points: 1. 2 weeks after starting the medication. 2. 4 weeks after starting the medication. timed up and go test (TUGT)