FARES Versus Traction-Countertraction for Acute Anterior Shoulder Dislocation
The FARES Versus Traction-Countertraction Technique for Acute Anterior Shoulder Dislocation: A Randomized Controlled Trial
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ngoc Quyen Le, MD, PhD
- Número de telefone: +84903818438
- E-mail: ngocquyenbs76@ump.edu.vn
Locais de estudo
-
-
Ho Chi Minh City
-
Ho Chi Minh City, Ho Chi Minh City, Vietnã, 700000
- Recrutamento
- Hospital for Traumatology and Orthopaedics
-
Contato:
- Ngoc Quyen Le, MD, PhD
- Número de telefone: +84903818438
- E-mail: ngocquyenbs76@ump.edu.vn
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: FARES Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
|
Closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
|
|
Comparador Ativo: Traction-Countertraction Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
|
Closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Successful reduction at the first attempt
Prazo: During the initial reduction procedure
|
Proportion of participants achieving successful reduction using the assigned technique without requiring an alternative reduction method.
|
During the initial reduction procedure
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to successful reduction
Prazo: During the reduction procedure
|
The time required to achieve successful reduction, measured from the beginning of the assigned reduction maneuver until restoration of shoulder joint alignment.
|
During the reduction procedure
|
|
Pain intensity during reduction procedure
Prazo: Immediately after completion of the reduction procedure
|
Pain intensity experienced by participants during the reduction procedure, assessed using the Visual Analog Scale (VAS).
The VAS is a continuous scale ranging from 0 (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse outcome.
|
Immediately after completion of the reduction procedure
|
|
Number of reduction attempts
Prazo: During the reduction procedure
|
The number of attempts required to achieve successful shoulder reduction using the assigned technique.
|
During the reduction procedure
|
|
Procedure-related complications
Prazo: During the reduction procedure and immediate post-reduction assessment
|
Incidence of complications related to the reduction procedure, including neurovascular complications and other adverse events.
|
During the reduction procedure and immediate post-reduction assessment
|
|
Factors associated with successful reduction
Prazo: From baseline assessment until completion of the reduction procedure
|
Odds ratio (with 95% confidence interval) for successful reduction associated with each baseline factor, estimated using multivariable logistic regression.
Successful reduction is defined as restoration of glenohumeral joint congruity confirmed on post-reduction radiography, achieved with the allocated technique without crossover to an alternative technique or the addition of procedural sedation.
Baseline factors entered into the model are age (years), sex (male/female), body mass index (kg/m²), mechanism of injury (fall / sports-related / road traffic accident / other), time from injury to reduction attempt (hours), history of recurrent shoulder dislocation (yes/no), and associated greater tuberosity fracture on pre-reduction radiography (yes/no).
|
From baseline assessment until completion of the reduction procedure
|
|
Pain intensity after reduction
Prazo: Immediately after successful reduction
|
Pain intensity after completion of the reduction procedure, assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
|
Immediately after successful reduction
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 155/2026/HĐ-ĐHYD
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .