Knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Professional statisticians will use SAS software to generate a random number sequence and its "central code assignment" (to specify the range of treatment codes assigned to each research center) accor
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 old 3. Experience recurrent knee pain for more than 1 month 4. Kellgren-Lawrence grading scale (K-L grading): Grade II or III 5. 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 <40mm 6. Provide informed consent, voluntarily participate in the study, and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects with clear surgical indications and unsuitable for conservative treatment 2. 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 surgery 3. Subjects allergic to the main components of the test drug, as well as those who have previously experienced skin allergies after using external medications 4. Subjects with skin diseases at and around the application site 5. 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 months 7. Women who have a positive blood pregnancy test result during the screening before enrollment; pregnant or lactating women 8. 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-up 9. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Joint stiffness symptoms and function measured using the stiffness and joint functional dimension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at baseline, and weeks 1, 2, and 3 2. Quality of life measured using the EuroQol 5-dimension questionnaire (EQ-5D-5L) at baseline, and weeks 1, 2, and 3 3. Degree of knee joint swelling measured using the circumference of the knee joint at baseline, and weeks 1, 2, and 3 4. Functional mobility of the knee joint measured using the knee joint range of motion assessed by a wearable joint range of motion measurement device at baseline, and weeks 1, 2, and 3 5. Safety measured using the laboratory test results (including blood routine, urine routine, and liver and kidney function) at baseline, and weeks 1 6. Safety measured using the adverse event records at weeks 1, 2, and 3 7. Safety measured using the severity of local skin reactions at the application site (assessed by 4 level scale, symptoms include itching, pain, burning sensation, erythema, papules, and blisters) at week 1 8. Patient compliance measured using the drug counting method and follow-up rate method at weeks 1, 2, and 3 9. Application status measured using application time, application quantity, detachment of the plaster, and medication experience at week 1 10. Application status measured using whether to use other treatment methods, and whether to engage in vigorous activities at weeks 1, 2, and 3 | — |
Countries
China
Contacts
Public ContactXisheng Weng
Outcome results
None listed