NCT01602653已完成不适用
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
University of Roma La Sapienza0 个研究点目标入组 46 人开始时间: 2008年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Constant Murley Scale
研究概览
简要总结
The purpose of this study is to compare two different ranges of energy flux density with Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no visible clinical benefits by previous conservative treatment
- •medium and large calcific deposits, according to Bosworth classification
- •type I and II Gartner deposits
排除标准
- •presence of tiny calcific deposits, according to Bosworth classification
- •type III, according to the Gartner classification
- •age (if less than 18 years old), diabetes, coagulation diseases or anticoagulant therapy, tumors, bone infections, previous shoulder surgery, pregnancy, pace-maker, acute bursitis demonstrated by ultrasound imaging, rheumatoid arthritis or other connective tissue diseases
结局指标
主要结局
Constant Murley Scale
时间窗: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint.
Constant-Murley scale is the scoring system used to assess shoulder function in four of the studies being reviewed. It combines physical examination tests with subjective evaluations by the patients and consists of 35 points and 65 points respectively. Its strength is the method of its application, which is quite clearly described, and its being an improvement on pre-existing scales
次要结局
- Visual Analogic Scale(The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention)
研究者
Francesco Ioppolo
MD, PhD
University of Roma La Sapienza
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