Randomized Clinical Trial Comparing the Spaso Maneuver Versus the Self-assisted Boss-Holzach-Matter for Anterior Shoulder Dislocations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pain that the patient experiences during the reduction procedure
研究概览
简要总结
To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician.
详细描述
Introduction
There are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method.
Hypothesis
The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso method assuming an equal success rate.
Objective
To determine whether the Boss-Holzach-Matter method is a less painful method for anterior shoulder dislocations compares to the Spaso method assuming equal success rate.
Methodology: Fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either Spaso reduction method performed by a physician or the self-assisted Boss-Holzach-Matter method.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area.
排除标准
- •Fracture luxation of the same shoulder.
- •Inability to cooperate due to mental or physical condition.
研究组 & 干预措施
Spaso Method
Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral
干预措施: Spaso method (Procedure)
Spaso Method
Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral
干预措施: Anti-Inflammatory Agents, Non-Steroidal (Drug)
Boss-Holzach-Matter Method
Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral
干预措施: Boss-Holzach-Matter method (Procedure)
Boss-Holzach-Matter Method
Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral
干预措施: Anti-Inflammatory Agents, Non-Steroidal (Drug)
结局指标
主要结局
Change From Baseline in Pain that the patient experiences during the reduction procedure
时间窗: Patients will be assessed throughout their visit to the Trauma Unit. No further following should be necessary.There will be no change in pain measurement, only the amount of pain felt during the manoeuvre.
Pain the patient feels during the reduction maneuver. The patient will be asked after reduction to fill out a form with a analog visual scale with scores ranging from 0 \[no pain\] to 10 \[worst possible pain\].
次要结局
未报告次要终点
研究者
Francesc A. Marcano-Fernández
Doctor
Corporacion Parc Tauli