Knee osteophyte formation
Conditions
Interventions
Experimental Group:Pain-Relieving Plaster
Positive drug control group:Yunnan Baiyao Plaster
Placebo group:Pain-relieving plaster simulant
Sponsors
Beijing University of Chinese Medicine Third Affiliated Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the Western diagnostic criteria for knee osteoarthritis. (2) Joint pain meeting the diagnostic criteria for chronic musculoskeletal pain. (3) Meeting the traditional Chinese medicine (TCM) syndrome differentiation criteria for Blood Stasis Obstructing Collaterals. (4) Maximum pain VAS score of the target knee = 40 within 24 hours before enrollment. (Target knee selection: 1) For unilateral knee involvement, the affected knee is the target; 2) For bilateral knee involvement with different VAS pain levels, the more painful knee is the target; otherwise, the left knee is the target.) (5) Target knee Kellgren-Lawrence (K-L) grade is II or III. (6) Age between 40 and 75 years old (inclusive), gender unrestricted. (7) Agree to participate in this clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Joint involvement due to other diseases, such as rheumatoid arthritis, psoriatic arthritis, syphilitic neuroarthropathy, ochronosis, etc. (2) Patients with transient synovitis, slipped capital femoral epiphysis, bone tuberculosis, bone tumor, acute trauma, pigmented villonodular synovitis, etc. (3) Received intra-articular injection in the target knee within 4 weeks before screening; or/and received disease-modifying agents (such as chondroprotectants, non-steroidal analgesics, systemic corticosteroids, etc.) within 2 weeks; or/and used topical medications for the target knee within 3 days prior to screening. (4) Liver function ALT or AST exceeding 2 times the upper limit of normal; renal function Scr exceeding 1.5 times the upper limit of normal. (5) Complicated with grade 3 hypertension, severe cardiac or pulmonary insufficiency, severe arrhythmia, severe primary diseases of the liver, kidney, hematopoietic, immune systems, skin cancer, or psychosis. (6) Skin ulceration, infection, redness, swelling, or eczema at the application site. (7) Planned surgical treatment for knee osteoarthritis within the next month. (8) Pregnant or lactating women. (9) History of allergy to topical drugs or known ingredients of the investigational products. (10) Participated in another clinical trial within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in pain VAS score compared to the baseline at day 14 after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of pain VAS score during the treatment period.;Time to first pain relief.;Pain relief rate at Day 7 and Day 14 after treatment.;Time to pain relief.;Change in pain VAS score from baseline to Day 7 after treatment.;Change in Western Ontario and McMaster Universities Osteoarthritis Index score from baseline to Day 7 and Day 14 after treatment.;Change in Chronic Musculoskeletal Pain Scale score from baseline to Day 7 and Day 14 after treatment.;Topical Patch Comfort Scale score at Day 7 and Day 14 after treatment.;Improvement rate based on Patient Global Impression of Change (PGI-C) at Day 7 and Day 14 after treatment.;TCM syndrome effective rate at Day 7 and Day 14 after treatment.;Diclofenac sodium sustained-release tablet utilization rate at Day 7 and Day 14 after treatment.; Change in Euro Qol 5-Dimension 5-Level (EQ-5D-5L) utility index from baseline to Day 7 and Day 14 after treatment.; | — |
Countries
China
Contacts
Public ContactWeiheng Chen
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Outcome results
None listed