Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Percent change in Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this study is to determine if applying a rigid splint helps to reduce pain following operative fixation of upper extremity fractures. Orthopedic trauma surgeons currently vary in their application of rigid post-operative splints versus soft dressings after certain surgical procedures based on personal preference. In this study, 100 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint or soft dressing post-operatively. Their pain, medication usage and function will be tracked over the 2- week postoperative period to see if splinting has any impact on outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to participate in study and complete consent
- •Will undergo operative fixation of an isolated both bone forearm, radial head, olecranon, distal humerus fracture, or humeral shaft fracture.
排除标准
- •Pregnant women
- •Patients with concomitant TBI or MR
- •Polytrauma patients
- •Pathologic Fractures
- •Patients undergoing treatment for malignancy
- •NYU SoM Students, Residents, Faculty
- •Prisoners
- •IV drug users or patients on chronic narcotics
- •Gun shot wound victims
研究组 & 干预措施
Splint
干预措施: Rigid Splint (Procedure)
Soft Dressing
干预措施: Soft Dressing (Procedure)
结局指标
主要结局
Percent change in Visual Analog Scale (VAS)
时间窗: 14 Days
Best state you can imagine is marked 100and the worst state you can imagine is marked 0 on a line
Percent Change in Euro Quality of Life (EQ-5D)
时间窗: 14 Days
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
次要结局
未报告次要终点