Pain eliminating plaster for the treatment of knee osteoarthritis: a multi-center, randomized, positive drug parallel-controlled clinical trial

Not Applicable

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN10047986
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-27
• Last Update Posted: 30 September 2024
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1. Meet the diagnostic criteria for knee osteoarthritis established by the American College of Rheumatology in 1995 (either single or both knees)2. Age between 40 and 75 years old3. Experience recurrent knee pain for more than 1 month4. Kellgren-Lawrence grading scale (K-L grading): Grade II or III5. Have at least one item with a VAS score =40mm among the five items of the WOMAC pain score for the study knee, and all items of the pain score for the contralateral knee osteoarthritis are <40mm6. Provide informed consent, voluntarily participate in the study, and sign the informed consent form

Exclusion Criteria

1. Subjects with clear surgical indications and unsuitable for conservative treatment2. Subjects with other inflammatory pain diseases in the knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, villonodular synovitis, septic arthritis, tuberculous arthritis, or osteoarthritis caused by osteomyelitis, bone tumors, and bone tuberculosis. Or those who have undergone joint replacement surgery3. Subjects allergic to the main components of the test drug, as well as those who have previously experienced skin allergies after using external medications4. Subjects with skin diseases at and around the application site5. Subjects with liver function abnormalities, specifically ALT Alanine Aminotransferase. and AST Aspartate Aminotransferase. levels exceeding twice the upper limit of normal, and renal function abnormalities, specifically Scr Serum Creatinine. levels exceeding 1.5 times the upper limit of normal, or subjects deemed by the researcher to have severe primary diseases that preclude their participation in the study. This includes patients with malignant tumors, infectious diseases, and mental illnesses.6. Subjects who have taken non-steroidal anti-inflammatory drugs orally within 1 week before the screening period, oral hormonal drugs within 1 month, received intra-articular injection therapy within 3 months, undergone joint surgery within 1 year, or experienced a definite knee injury or open injury within 6 months7. Women who have a positive blood pregnancy test result during the screening before enrollment; pregnant or lactating women8. Subjects who, according to the researcher's judgment, have a low probability of enrollment or other circumstances that complicate enrollment, such as those with frequently changing work environments or frequent business trips, which may easily lead to loss of follow-up9. Subjects who have used Chinese medicine therapies with therapeutic effects on knee osteoarthritis, such as infrared irradiation, cupping, acupuncture, proprietary Chinese medicines, or those participating in other clinical studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain is measured using the pain dimension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score scale (5 items, totaling 500 points) at baseline, and at weeks 1, 2, and 3