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FARES Versus Traction-Countertraction for Acute Anterior Shoulder Dislocation

14. september 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
        • Rekruttering
        • Hospital for Traumatology and Orthopaedics
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: FARES Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
Closed reduction of acute anterior shoulder dislocation using the FARES (Fast, Reliable, and Safe) technique.
Aktiv komparator: Traction-Countertraction Technique
Participants assigned to this arm will undergo closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.
Closed reduction of acute anterior shoulder dislocation using the conventional traction-countertraction technique.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Successful reduction at the first attempt
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to successful reduction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. april 2027

Datoer for studieregistrering

Først innsendt

25. juli 2026

Først innsendt som oppfylte QC-kriteriene

5. august 2026

Først lagt ut (Faktiske)

11. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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