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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ngoc Quyen Le, MD, PhD
- Numer telefonu: +84903818438
- E-mail: ngocquyenbs76@ump.edu.vn
Lokalizacje studiów
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, Wietnam, 700000
- Rekrutacyjny
- Hospital for Traumatology and Orthopaedics
-
Kontakt:
- Ngoc Quyen Le, MD, PhD
- Numer telefonu: +84903818438
- E-mail: ngocquyenbs76@ump.edu.vn
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: FARES Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
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Closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
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Aktywny komparator: Traction-Countertraction Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
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Closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Successful reduction at the first attempt
Ramy czasowe: During the initial reduction procedure
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Proportion of participants achieving successful reduction using the assigned technique without requiring an alternative reduction method.
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During the initial reduction procedure
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time to successful reduction
Ramy czasowe: During the reduction procedure
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The time required to achieve successful reduction, measured from the beginning of the assigned reduction maneuver until restoration of shoulder joint alignment.
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During the reduction procedure
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Pain intensity during reduction procedure
Ramy czasowe: Immediately after completion of the reduction procedure
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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.
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Immediately after completion of the reduction procedure
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Number of reduction attempts
Ramy czasowe: During the reduction procedure
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The number of attempts required to achieve successful shoulder reduction using the assigned technique.
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During the reduction procedure
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Procedure-related complications
Ramy czasowe: During the reduction procedure and immediate post-reduction assessment
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Incidence of complications related to the reduction procedure, including neurovascular complications and other adverse events.
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During the reduction procedure and immediate post-reduction assessment
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Factors associated with successful reduction
Ramy czasowe: From baseline assessment until completion of the reduction procedure
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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).
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From baseline assessment until completion of the reduction procedure
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Pain intensity after reduction
Ramy czasowe: Immediately after successful reduction
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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).
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Immediately after successful reduction
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 155/2026/HĐ-ĐHYD
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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