NCT01486420已完成不适用
Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.
Jeppe Lange, MD1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Quinell grade
研究概览
简要总结
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trigger finger Quinell grade IIb-V in digit I-V
排除标准
- •Former treatment of Trigger finger in affected digit
- •Dupuytrens contracture in affected digit
- •Allergies or intolerance to used medications
- •Rheumatoid Arthritis
- •Insulin dependent Diabetes Mellitus
- •Amyloidosis
- •Mucopolysaccharidosis
- •Already included in study with another digit
研究组 & 干预措施
Open surgery
Active Comparator
干预措施: Open surgery (Procedure)
Corticosteroid Injection
Active Comparator
干预措施: Corticosteroid injections (Procedure)
结局指标
主要结局
Quinell grade
时间窗: 12 months
Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb. Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.
次要结局
- Numerical Rating Scale (NRS) score(12 weeks)
- infection(12 weeks)
研究者
Jeppe Lange, MD
Senior project superviser
Regionshospitalet Silkeborg
研究点 (1)
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