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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ngoc Quyen Le, MD, PhD
- Número de teléfono: +84903818438
- Correo electrónico: ngocquyenbs76@ump.edu.vn
Ubicaciones de estudio
-
-
Ho Chi Minh City
-
Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
- Reclutamiento
- Hospital for Traumatology and Orthopaedics
-
Contacto:
- Ngoc Quyen Le, MD, PhD
- Número de teléfono: +84903818438
- Correo electrónico: ngocquyenbs76@ump.edu.vn
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Successful reduction at the first attempt
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to successful reduction
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 155/2026/HĐ-ĐHYD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .