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FARES Versus Traction-Countertraction for Acute Anterior Shoulder Dislocation

14. September 2026 aktualisiert von: Ngoc Quyen Le

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vietnam
    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
        • Rekrutierung
        • Hospital for Traumatology and Orthopaedics
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: FARES Technique
Closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
Aktiver Komparator: Traction-Countertraction Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
Verfahren: Traction-Countertraction Technique
Closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Successful reduction at the first attempt
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to successful reduction
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ngoc Quyen Le

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

25. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. August 2026

Zuerst gepostet (Tatsächlich)

11. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 155/2026/HĐ-ĐHYD

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared with other researchers. The collected data contain clinical information obtained from participants during the study, and sharing individual-level data was not included in the approved study protocol. Only aggregated and anonymized results will be reported in scientific publications.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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