- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07652671
Modified Cunningham Technique for Anterior Shoulder Dislocation
Comparison of the Standard Cunningham Technique and the Modified Cunningham Technique in Terms of Reduction Success and Emergency Department Discharge Time in Patients With Anterior Shoulder Dislocation: A Two-Center Prospective Randomized Study
Anterior shoulder dislocation is a common emergency condition that usually requires closed reduction in the emergency department. Several reduction techniques are used in clinical practice, and the ideal method should be effective, fast, easy to perform, well tolerated by the patient, and associated with a low need for sedation.
This two-center prospective randomized study compares the standard Cunningham technique with a modified Cunningham technique in adult patients presenting to the emergency department with anterior shoulder dislocation. Eligible patients were randomly assigned to one of two groups: standard Cunningham technique or modified Cunningham technique.
The main aim of the study is to compare the success rate of shoulder reduction between the two techniques. Secondary aims include comparing reduction time, pain level measured by the Visual Analog Scale, need for additional reduction maneuvers, need for sedation, emergency department discharge time, and procedure-related complications.
The study is designed to determine whether the modified Cunningham technique can provide faster and more successful shoulder reduction without increasing patient discomfort or complication risk.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Anterior shoulder dislocation is one of the most common joint dislocations encountered in emergency departments. Closed reduction is the standard initial treatment in suitable patients. Although several reduction techniques are available, many methods require traction, patient tolerance, analgesia, or procedural sedation. These factors may prolong the reduction process, increase emergency department workload, and expose patients to sedation-related risks.
The Cunningham technique is a seated, patient-cooperation-based shoulder reduction method that aims to facilitate reduction by relaxation of the shoulder girdle muscles and massage of the biceps, deltoid, and trapezius muscles. The modified Cunningham technique used in this study preserves the basic principles of the standard technique but adds a controlled positioning maneuver. In the modified technique, the patient's affected hand is placed on the volar aspect of the physician's elbow, while the physician supports the patient's elbow and applies gentle downward pressure to the antecubital region together with muscle massage. This modification is intended to provide better control of the extremity, facilitate muscle relaxation, and support reduction without forceful traction.
This was a two-center, prospective, randomized, open-label, parallel-group study conducted in emergency department settings. Adult patients presenting with acute anterior shoulder dislocation were evaluated for eligibility. Patients meeting the inclusion criteria were randomly assigned to undergo closed reduction using either the standard Cunningham technique or the modified Cunningham technique.
The reduction procedure was performed by emergency physicians according to the assigned technique. Reduction success was assessed clinically and confirmed by post-reduction radiographic imaging when clinically appropriate. In patients in whom the assigned initial technique was unsuccessful, further management, including additional reduction maneuvers, procedural sedation, or orthopedic consultation, was performed according to routine clinical practice.
The study was designed to evaluate whether the modified Cunningham technique improves the clinical efficiency of anterior shoulder dislocation reduction in the emergency department without increasing pain or procedure-related complications. No investigational drug, biological product, or medical device was used in this study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
konyaaltı
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Antalya, konyaaltı, Turquía (Türkiye), 07100
- University of Health Sciences, Antalya Training and Research Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Presentation to the emergency department with acute anterior shoulder dislocation
- Diagnosis of anterior shoulder dislocation confirmed by clinical examination and radiographic imaging
- Conscious and cooperative patients who are able to comply with the seated reduction procedure
- No associated mechanical pathology such as fracture, open wound, laceration, foreign body, or other traumatic condition preventing closed reduction
- Ability to provide written informed consent for participation in the study
Exclusion Criteria:
- Refusal to participate in the study
- Missing or unavailable study data
- Posterior or inferior shoulder dislocation
- Fracture-dislocation or associated fracture
- Open shoulder injury or significant laceration
- Foreign body or other mechanical pathology involving the affected shoulder
- Neurovascular deficit requiring urgent surgical or orthopedic evaluation
- Multiple trauma
- Altered mental status or inability to cooperate during the procedure
- Previous surgery on the affected shoulder
- Unsuitability for reduction in the seated position
- Requirement for immediate procedural sedation before the first reduction attempt
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 |
|---|---|
|
Comparador activo: Standard Cunningham Technique
Participants in this arm underwent closed reduction of anterior shoulder dislocation using the standard Cunningham technique.
The patient was placed in a seated position, and reduction was attempted through patient relaxation and massage of the biceps, deltoid, and trapezius muscles without forceful traction.
|
Closed reduction of anterior shoulder dislocation using the standard Cunningham technique.
The participant is seated, the affected upper extremity is supported in adduction and elbow flexion, and the physician applies massage to the biceps, deltoid, and trapezius muscles to facilitate muscle relaxation and shoulder reduction without forceful traction.
|
|
Experimental: Modified Cunningham Technique
articipants in this arm underwent closed reduction of anterior shoulder dislocation using the modified Cunningham technique.
The patient was placed in a seated position, and the affected hand was positioned on the volar aspect of the physician's elbow.
The physician supported the patient's elbow and applied gentle downward pressure to the antecubital region while performing massage of the biceps, deltoid, and trapezius muscles to facilitate reduction without forceful traction.
|
Closed reduction of anterior shoulder dislocation using the modified Cunningham technique.
The participant is seated, and the affected hand is placed on the volar aspect of the physician's elbow.
The physician supports the participant's elbow and applies gentle downward pressure to the antecubital region while performing massage of the biceps, deltoid, and trapezius muscles to facilitate reduction without forceful traction.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Successful Shoulder Reduction Rate
Periodo de tiempo: 1 hour
|
Success rate of anterior shoulder dislocation with modified Cunningham reduction technique
|
1 hour
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction Time
Periodo de tiempo: 1 hour
|
The time elapsed from the initiation of the modified Cunningham reduction maneuver to clinical confirmation of shoulder reduction.
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1 hour
|
|
Procedure-Related Pain Score
Periodo de tiempo: 1 hour
|
Pain intensity associated with the reduction procedure was assessed using the Visual Analog Scale.
Higher scores indicate greater pain intensity.
(0: no pain.
10: most severe pain)
|
1 hour
|
|
Need for Additional Reduction Maneuver
Periodo de tiempo: 1 hour
|
The proportion of participants who required an additional reduction maneuver after failure of the initially assigned technique.
|
1 hour
|
|
Need for Procedural Sedation
Periodo de tiempo: 1 hour
|
The proportion of participants who required procedural sedation due to unsuccessful reduction or inadequate tolerance of the initially assigned reduction technique.
|
1 hour
|
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Emergency Department Discharge Time
Periodo de tiempo: Procedure-Related Complications
|
The time from emergency department admission to discharge from the emergency department, measured in minutes.
|
Procedure-Related Complications
|
|
Procedure-Related Complications
Periodo de tiempo: 1 hour
|
Complications related to the procedure include: neurovascular injury, fracture, recurrent dislocation, need for orthopedic consultation, or the need for further intervention.
|
1 hour
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: MURAT DUYAN, University of Health Sciences, Antalya Training and Research Hospital
- Silla de estudio: SULEYMAN IBZE, ASSISTANT PROFESSOR, Akdeniz universty
Publicaciones y enlaces útiles
Publicaciones Generales
- Cutts S, Prempeh M, Drew S. Anterior shoulder dislocation. Ann R Coll Surg Engl. 2009 Jan;91(1):2-7. doi: 10.1308/003588409X359123.
- Cunningham NJ. Techniques for reduction of anteroinferior shoulder dislocation. Emerg Med Australas. 2005 Oct-Dec;17(5-6):463-71. doi: 10.1111/j.1742-6723.2005.00778.x.
- Cunningham N. A new drug free technique for reducing anterior shoulder dislocations. Emerg Med (Fremantle). 2003 Oct-Dec;15(5-6):521-4. doi: 10.1046/j.1442-2026.2003.00512.x.
- Riebel GD, McCabe JB. Anterior shoulder dislocation: a review of reduction techniques. Am J Emerg Med. 1991 Mar;9(2):180-8. doi: 10.1016/0735-6757(91)90187-o. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 775
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
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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