ISRCTN10047986进行中（未招募）Unknown
Pain eliminating plaster versus flurbiprofen cataplasms in terms of pain, stiffness, functional activities, joint swelling, quality of life, and safety for knee osteoarthritis treatment: a multi-center, randomized, controlled, non-inferiority clinical trial.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 主要终点
- 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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Meet the diagnostic criteria for knee osteoarthritis established by the American College of Rheumatology in 1995 (either single or both knees)
- •Age between 40 and 75 years old
- •Experience recurrent knee pain for more than 1 month
- •Kellgren-Lawrence grading scale (K-L grading): Grade II or III
- •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
- •Provide informed consent, voluntarily participate in the study, and sign the informed consent form
排除标准
- •Subjects with clear surgical indications and unsuitable for conservative treatment
- •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
- •Subjects allergic to the main components of the test drug, as well as those who have previously experienced skin allergies after using external medications
- •Subjects with skin diseases at and around the application site
- •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.
- •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
- •Women who have a positive blood pregnancy test result during the screening before enrollment; pregnant or lactating women
- •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
- •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
结局指标
主要结局
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
次要结局
未报告次要终点
研究者
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