NCT05909930暂停不适用
Effectiveness of TheRApeutic ExercIse aNd EDucation on Patients With Massive Rotator Cuff Tears (the TRAINED Study): a Multicenter Non-controlled Trial
Hospital Universitario Fundación Alcorcón1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Shoulder disability
研究概览
简要总结
The aim of this multicenter non-controlled study will be to evaluate the effectiveness of a physical therapy treatment based on resistance exercise and education for patients with massive rotator cuff tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Massive rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging. The definition of massive will be the rears including 2 or more tneonds, or the ones with an extension equal or greater to 5cm in the short or long axis.
- •To have a degree of disability equal or greater to 15% in the Oxford Shoulder Score.
- •Adequate comprehension of written and spoken Spanish
排除标准
- •Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.
- •Suspected neck-related shoulder pain.
- •Suspected visceral-related shoulder pain.
- •Humerus and/or scapular fractures within the last year.
- •Previous rotator cuff repair surgery within the last year.
- •Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.
- •Cognitive impairment that makes it impossible to perform therapeutic exercise.
结局指标
主要结局
Shoulder disability
时间窗: Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Shoulder disability measured with the Oxford Shoulder Score, which ranges from 0 (no disability) to 100 (maximum degree of disability).
次要结局
- Shoulder pain intensity(Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.)
- Need for surgery(3-month, 6-month, and 1-year.)
研究者
Rubén Fernández Matías
Principal Investigator
Hospital Universitario Fundación Alcorcón
研究点 (1)
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