- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
konyaaltı
-
Antalya, konyaaltı, Turecko (Türkiye), 07100
- University of Health Sciences, Antalya Training and Research Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Successful Shoulder Reduction Rate
Časové okno: 1 hour
|
Success rate of anterior shoulder dislocation with modified Cunningham reduction technique
|
1 hour
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Reduction Time
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Procedure-Related Complications
|
The time from emergency department admission to discharge from the emergency department, measured in minutes.
|
Procedure-Related Complications
|
|
Procedure-Related Complications
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: MURAT DUYAN, University of Health Sciences, Antalya Training and Research Hospital
- Studijní židle: SULEYMAN IBZE, ASSISTANT PROFESSOR, Akdeniz universty
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 775
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Dislokace předního ramene
-
Istanbul Physical Medicine Rehabilitation Training...DokončenoMrtvice | Architektura musculus tibialis anteriorTurecko (Türkiye)
-
Antalya City HospitalZatím nenabírámePooperační bolest | Videoasistovaná hrudní chirurgie (VATS) | Serratus Posterior Superior Intercostal Plane Block | Hluboký blok přední pilovité roviny (hluboký serratus anterior plane block)Turecko (Türkiye)
Klinické studie na Standard Cunningham Technique
-
Institut Claudius RegaudDokončenoMETASTATICKÁ RAKOVINAFrancie
-
Hofseth Biocare ASAKGK Science Inc.DokončenoCovid-19 | COVIDKanada, Brazílie, Maďarsko, Mexiko, Srbsko
-
City University of New York, School of Public HealthNew York State Psychiatric Institute; University of KwaZulu; International Initiative... a další spolupracovníciDokončeno
-
Barron Associates, Inc.University of North DakotaDokončenoPoruchy oční motility | AmblyopieSpojené státy
-
Université de MontréalNáborArtritida rameneKanada
-
JHP Pharmaceuticals LLCSyneos HealthNeznámý
-
WepromZatím nenabírámeLeukémie, myeloidní, akutní | Metastatická rakovina | Rakovina, konečník | Myelodysplazie | Rakovina, prsa | Myelom | Leukémie, lymfocytární, akutní | Rakovina, plíce | Rakovina tlustého střeva | Leukémie, lymfocytární, chronická | Rakovina, ledviny | Rakovina slinivky břišní | Rakovina prostaty | Leukémie, myeloidní,... a další podmínkyFrancie
-
Kyoto University, Graduate School of MedicineDokončenoSrdeční selhání, diastolické | Městnavé srdeční selhání | Srdeční selhání, systolické | Starší Frail | Dodržování pokynůJaponsko
-
Children's Hospital of PhiladelphiaPatient-Centered Outcomes Research InstituteNáborSupraglotické dýchací cesty | Novorozenecká resuscitace | Kojenec, novorozenec | Implementační výzkum | Resuscitace na porodním sále | Pozitivní tlaková ventilace | Laryngeální maska AirwaysSpojené státy