The FARES Versus Traction-Countertraction Technique for Acute Anterior Shoulder Dislocation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Successful reduction at the first attempt
研究概览
简要总结
Anterior shoulder dislocation is a common orthopedic emergency that requires prompt reduction to relieve pain and restore joint function. Several techniques have been described for closed reduction, but the optimal method remains uncertain. The FARES (Fast, Reliable, and Safe) technique is a relatively new reduction method that may provide faster reduction with less pain compared with the conventional traction-countertraction technique.
This randomized controlled trial aims to compare the effectiveness and safety of the FARES technique and the traction-countertraction technique for the reduction of acute anterior shoulder dislocation in adult patients.
Eligible participants will be randomly assigned to receive reduction using either the FARES technique or the traction-countertraction technique. The study will evaluate the success rate of reduction, pain experienced during the procedure, time required for reduction, and procedure-related complications.
The findings of this study may provide evidence to guide the selection of reduction techniques for patients with acute anterior shoulder dislocation in the emergency department.
详细描述
Acute anterior shoulder dislocation is one of the most common orthopedic emergencies and requires timely reduction to relieve pain, restore joint alignment, and minimize complications. Various closed reduction techniques have been described, but there is still no universal consensus regarding the optimal technique in terms of effectiveness, patient comfort, and procedural efficiency.
The FARES (Fast, Reliable, and Safe) technique is a relatively recent method for closed reduction of anterior shoulder dislocation. This technique combines gentle longitudinal traction, oscillating movements, and gradual abduction of the arm, aiming to facilitate reduction while minimizing patient discomfort. The traction-countertraction technique is a commonly used conventional method that relies on opposing forces applied by the operator and an assistant.
This study is designed to compare the outcomes of these two reduction techniques in adult patients with acute anterior shoulder dislocation. The study will evaluate whether the FARES technique provides advantages over the traction-countertraction technique regarding reduction success, pain during the procedure, reduction time, and safety outcomes.
The results of this trial may contribute to improving evidence-based decision-making for the management of acute anterior shoulder dislocation in emergency care settings.
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
盲法说明
This is an open-label study because the reduction technique cannot be masked to participants or investigators.
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
- •Age ≥18 years.
- •Conscious and cooperative patients.
- •Anterior shoulder dislocation confirmed by shoulder radiographs (anteroposterior view and Y-view).
- •Time from injury to reduction <24 hours.
- •Simple anterior shoulder dislocation or anterior shoulder dislocation associated with greater tuberosity fracture only.
- •Patient agrees to participate in the study and provides informed consent.
排除标准
- •Other injuries of the same upper extremity.
- •Neurovascular deficits before reduction.
- •Polytrauma, hemodynamic instability, or medical conditions contraindicating immediate reduction.
- •Previous surgery of the affected shoulder.
研究组 & 干预措施
FARES Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
干预措施: FARES Technique (Procedure)
Traction-Countertraction Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
干预措施: Traction-Countertraction Technique (Procedure)
结局指标
主要结局
Successful reduction at the first attempt
时间窗: During the initial reduction procedure
Proportion of participants achieving successful reduction using the assigned technique without requiring an alternative reduction method.
次要结局
- Time to successful reduction(During the reduction procedure)
- Pain intensity during reduction procedure(Immediately after completion of the reduction procedure)
- Number of reduction attempts(During the reduction procedure)
- Procedure-related complications(During the reduction procedure and immediate post-reduction assessment)
- Factors associated with successful reduction(From baseline assessment until completion of the reduction procedure)
- Pain intensity after reduction(Immediately after successful reduction)
研究者
Ngoc Quyen Le
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City