NCT01029600Unknown不适用
Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study
Bergen Surgical Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Shoulder Function
研究概览
简要总结
The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.
详细描述
Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.
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 (Outcomes Assessor)
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 understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up
- •The patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder.
- •External rotation 20 degrees or less
- •Abduction 45 degrees or less
- •The patients must not be in phase 1 (inflammation phase)
- •Diabetics may be included
- •MRI must be taken to exclude other reasons for stiffness
排除标准
- •Other reasons for stiffness( cuff rupture, arthritis)
- •Posttraumatic or postoperative stiffness
- •Patients not suited for day surgery
- •Patients with a history of subacromial impingement before developing stiffness
结局指标
主要结局
Shoulder Function
时间窗: 2 years
次要结局
- Shoulder range of motion(2 years)
研究者
研究点 (2)
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