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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 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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240616003
Enrollment
60
Registered
2024-06-16
Start date
2024-07-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of knee Osteoarthritis of knee S-flurbiprofen plaster Acupuncture points Pain KOOS The Knee Injury and Osteoarthritis Outcome Score

Interventions

Volunteers will receive S-flurbiprofen plaster( 40 milligrams per sheet), sized 10x14 square centimaters They will be instructed on the following usage: 1. Apply one sheet to the painful knee area onc
Active Comparator Drug,Experimental Drug
S-flurbiprofen plaster 40 mg,S-flurbiprofen plaster 20 mg

Sponsors

The faculty of medicine Siriraj hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Thailand

Contacts

Public ContactKamontip Harnphadungkit

Faculty of medicine, Mahidol university

kamontip.har@mahidol.ac.th024197508

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026