Comparison of the Effectiveness in Pain Reduction Between a Rib Splint Produced in the ER and a Manufactured Rib Splint: Preliminary Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 主要终点
- The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration
研究概览
简要总结
A pilot study for a prospective randomized clinical trial was conducted to compare subjects using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the intervention.
The primary outcome was difference in the level of pain based on the visual analogue scale (VAS) between before and after intervention in each group during forceful and resting respiration.
VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis
详细描述
Investigators performed VAS assessments to determine the level of pain in the subjects with RFs during resting and forceful respiration. Investigators applied either the CCO rib splint or the ER splint to the RF subjects in a randomized order. At 30 minutes after splint application, investigators repeated the VAS assessments during resting and forceful respiration. Subsequently, additional pain control was provided via intravascular drug injection.
RF : Rib fractures VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have rib fractures and age was over 18 years old
排除标准
- •Investigators excluded subjects with cardiopulmonary dysfunction, poly-trauma, flail chest, damage to an internal organ, or alcoholism and subjects who did not consent to participate.
结局指标
主要结局
The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration
时间窗: We check a pain scale at 30 minutes after splint application
Comparison CCO Rib splint with Handmade Rib splint about pain reduction
次要结局
未报告次要终点
研究者
LEE YOON-JE
Clinical Assistant Professor
Hanyang University