A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- American Shoulder Elbow Society Score
研究概览
简要总结
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
详细描述
THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proximal Humerus Fracture
- •Decreased range of motion at 6 wk follow-up
- •Likely to be available for follow up for 26 wks
排除标准
- •Known drug allergy to kenalog or lidocaine
- •Unable to complete functional outcome
- •Pregnant Women
研究组 & 干预措施
Cases
Patients receiving Kenalog
干预措施: kenalog (Drug)
Controls
Patients receiving lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
American Shoulder Elbow Society Score
时间窗: 24 weeks
Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
次要结局
- Visual Analogue Scale(24 weeks)
研究者
Jonah Hebert-Davies
Assistant Professor, School of Medicine: Orthopedics
University of Washington