- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
konyaaltı
-
Antalya, konyaaltı, Turquia (Türkiye), 07100
- University of Health Sciences, Antalya Training and Research Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
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 |
|---|---|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Successful Shoulder Reduction Rate
Prazo: 1 hour
|
Success rate of anterior shoulder dislocation with modified Cunningham reduction technique
|
1 hour
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Reduction Time
Prazo: 1 hour
|
The time elapsed from the initiation of the modified Cunningham reduction maneuver to clinical confirmation of shoulder reduction.
|
1 hour
|
|
Procedure-Related Pain Score
Prazo: 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
Prazo: 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
Prazo: 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
|
|
Emergency Department Discharge Time
Prazo: Procedure-Related Complications
|
The time from emergency department admission to discharge from the emergency department, measured in minutes.
|
Procedure-Related Complications
|
|
Procedure-Related Complications
Prazo: 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
- Cadeira de estudo: SULEYMAN IBZE, ASSISTANT PROFESSOR, Akdeniz universty
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- 775
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 .
Ensaios clínicos em Luxação anterior do ombro
-
Alexander Rofner-MorettiRecrutamentoRuptura do Ligamento Cruzado Anterior | Reconstrução do Ligamento Cruzado Anterior | Lesão do Ligamento Cruzado AnteriorÁustria
-
Heidelberg Engineering GmbHAtivo, não recrutandoOlhos com segmento anterior normal | Olhos com segmento anterior anormalEstados Unidos
-
Heidelberg Engineering GmbHRescindidoOlhos com segmento anterior normal | Olhos com segmento anterior anormalEstados Unidos
-
University of California, San FranciscoKhon Kaen University; King Chulalongkorn Memorial Hospital; Huang Pacific FoundationRescindidoUveíte anterior por citomegalovírusTailândia, Estados Unidos
-
Aldeyra Therapeutics, Inc.ConcluídoUveíte anterior não infecciosaEstados Unidos
-
Federal University of Health Science of Porto AlegreRecrutamentoReconstrução do Ligamento Cruzado Anterior | Reabilitação da Reconstrução do Ligamento Cruzado AnteriorBrasil
-
Federal University of Health Science of Porto AlegreRecrutamentoReconstrução do Ligamento Cruzado Anterior | Reabilitação da Reconstrução do Ligamento Cruzado AnteriorBrasil
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalAinda não está recrutandoReconstrução do Ligamento Cruzado Anterior (LCA) | Lesão do Ligamento Cruzado Anterior (LCA) | Ruptura do ligamento cruzado anterior (ACL)Turquia (Türkiye)
-
Alcon ResearchConcluído
-
Alcon ResearchConcluídoUveíte Anterior EndógenaEstados Unidos
Ensaios clínicos em Standard Cunningham Technique
-
Institut Straumann AGRescindido
-
Indus Hospital and Health NetworkConcluídoDor pós-operatória | Cálculos renaisPaquistão
-
Eskisehir Osmangazi UniversityAinda não está recrutandoDiarréia Infecciosa Aguda em Crianças
-
Case Comprehensive Cancer CenterFlorida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)Recrutamento
-
National Taiwan University HospitalAinda não está recrutandoAnestesia Intravenosa | Respiração Espontânea
-
Fu Jen Catholic University HospitalRecrutamentoDoença Renal Crônica (DRC) | CKD Estágio 1-3Taiwan
-
Hospital Clinica NovaConcluído
-
Karaganda Medical UniversityConcluídoCOVID 19 | Estresse oxidativo | Deficiências CognitivasCazaquistão
-
Sophiahemmet UniversityKarolinska Institutet; Linnaeus University; The Swedish School of Sport and Health... e outros colaboradoresRecrutamento
-
University of OxfordConcluído