NCT01544244终止不适用
Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- change in FI2S score
研究概览
简要总结
The primary objective of this study is to demonstrate the superiority of the CGE physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the FI2S score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.
详细描述
Secondary objectives:
- To study the evolution of passive glenohumeral range of motion
- To study the evolution of the global range of passive and active motion for each method used
- To evaluate functional recovery (DASH)
- To evaluate the impact on quality of life (SF36)
- To study the difference in visual analog scale scores for pain during physical therapy sessions
- Compare the two methods/groups after three months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •painful, chronic tendinopathy (more than 3 months) of the rotator cuff, confirmed by MRI
排除标准
- •The patient is pregnant or breastfeeding
- •Any emergency situation
- •Non-mechanical tendinopathies (metabolic, neurological, capsulitis, reflex sympathetic dystrophy) and tendon surgery (tendon surgery and acromioplasty)
结局指标
主要结局
change in FI2S score
时间窗: 90 days
次要结局
- Change in visual analog scale for pain(Day 90 versus baseline)
- Scapulohumeral amplitude gain in 3 main directions(Day 90)
- Functional gain as measured by the DASH self questionnaire(Day 90)
- FI2S score(Day 26)
- SF36 self questionnaire(Day 90)
研究者
研究点 (4)
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