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临床试验/NCT03806205
NCT03806205Unknown不适用

Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
adherence

研究概览

简要总结

To investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. To evaluate the pain relief rate of patients with different initial pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • According to the OA diagnostic criteria of knee joint, the side with higher WOMAC score is defined as observing knee joint for patients with both knees conforming to OA diagnostic criteria.
  • Repeated knee pain in the past month
  • X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin.
  • Joint fluid (> 2 times) is cool and sticky, WBC < 2000/ml
  • Age over 40
  • Morning stiffness less than 30 minutes
  • Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or 1+4+5+6, OA of knee joint can be diagnosed.
  • The informed consent has been signed

排除标准

  • (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe internal medical complications and other inability to participate in the research (4) Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study

结局指标

主要结局

adherence

时间窗: 6-8 weeks

We will calculate adherence with medication use

pain relief rate

时间窗: 6-8 weeks

We will calculate the pain relief rate on all participants

次要结局

  • womac score(6-8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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