Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Active elevation of the affected shoulder
研究概览
简要总结
The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.
详细描述
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).
Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of frozen shoulder of at least one month duration
排除标准
- •shoulder arthritis
- •rotator cuff tears
- •any chronic, serious, uncontrolled medical condition
- •inability to conform to study visits (20-30 per year)
研究组 & 干预措施
Collagenase
Collagenase Injection
干预措施: Collagenase (Drug)
Placebo
Placebo Injection
干预措施: Collagenase (Drug)
结局指标
主要结局
Active elevation of the affected shoulder
时间窗: 30 days
Active Elevation in degrees by goniometer measurement
次要结局
- Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.(30 days)
研究者
Marie Badalamente
Professor Orthopaedics
Stony Brook University