NCT03962270Unknown不适用
Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- magnetic resonance imaging of knee
研究概览
简要总结
In this study, the effectiveness of ESWT in the treatment of knee OA was investigated from the perspective of cartilage injury，and to prove that shockwave could delay the early and middle stage OA progression by improving cartilage condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee joint ROM normal or near normal: flexion 110 ° or reach 0 ° or less
- •MR prompt exist cartilage damage, there is no lack of full-thickness cartilage
- •Kellgren - Lawrence (K - L) grade II - III grade
- •The international association of cartilage repair cartilage damage grading system (ICRS) class I - III
- •Informed consent and sign relevant documents
- •Follow doctor's instructions and follow up on time
排除标准
- •Metabolic arthritis
- •Trauma of bone joint
- •Inflammatory diseases
- •Previous knee surgery history
- •History of knee cavity injection in the past 6 months
- •Serious cardiovascular diseases, pulmonary diseases or other serious diseases affecting survival, etc
研究组 & 干预措施
Treatment group
Experimental
干预措施: shock wave device (Device)
Control group
Sham Comparator
干预措施: shock wave device (Device)
结局指标
主要结局
magnetic resonance imaging of knee
时间窗: Three months after treatment
t2 mapping
次要结局
未报告次要终点
研究者
Mouwang Zhou
senior professional post
Peking University Third Hospital
研究点 (1)
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