Condition category
Musculoskeletal Diseases
Date applied
28/01/2009
Date assigned
27/02/2009
Last edited
27/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fares Sayegh

ORCID ID

Contact details

Third Orthopaedic Department
Papageorgiou General Hospital
Ring-Road
N
Efkarpia
Thessaloniki
546 03
Greece

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The new FARES (FAst REliable Safe) method of reduction of the acute anterior dislocation of the shoulder: a prospective randomised comparative study

Acronym

Study hypothesis

Anterior dislocations of the glenohumeral joint are very common. This is probably the result of the shoulder anatomy that predisposes to instability. There are several methods of reduction of the anterior dislocation of the shoulder, including those introduced by Hippocrates, Kocher Milch and Stimpson; rates of success and complications following reduction range according to the method used. Although most anterior shoulder dislocations can be easily reduced at the Accident and Emergency Departments (AE) of most hospitals, some dislocations will still require the implementation of more than one method(s) and in 5% to 10% of cases, reduction can only be achieved at an operating theatre.

The optimal method of reduction should require minimal assistance to the physician performing it and it ought to be highly effective, quick, safe and painless. Choosing which method to use is a whole different issue, since most physicians seldom base their decision on objective criteria. This however is more or less expected since there are only a few studies in the literature that compare the efficacy, safety and reliability among different techniques and most of them are lacking comparison groups, blinded methodology, or proper statistical analysis.

This trial compares the efficacy of the FARES (FAst REliable Safe) method, a new method to reduce shoulder dislocation, against two traditional methods ("Hippocrates" and "Kocher" methods).

Ethics approval

Scientific and Ethical Committee, Papageorgiou General Hospital of Thessaloniki, approved on 29/09/2008.

Study design

Prospective parallel-group randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Traumatic shoulder dislocation

Intervention

Participants were randomly allocated to the following three arms:
1. The FARES method
2. The "Hippocrates" method
3. The "Kocher" method

Duration of treatment for each participant was up to 10 min in all arms.

All trial outcomes were assessed immediately after the treatment (no follow-up assessments).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Efficacy of each individual method as far as the reduction of the shoulder dislocation was concerned. The efficacy was validated by x-rays following the reduction attempt and by the ability of the patient to perform voluntary and painless movements of the affected arm.

Secondary outcome measures

1. Evaluation of the pain felt during the reduction, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain)
2. Evaluation of the existence of any immediate complication following the reduction of the shoulder dislocation

Overall trial start date

01/09/2006

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (>18 years old), both males and females
2. Patients suffering from 'first-time' traumatic anterior dislocation of the shoulder (either accompanied by a fracture of the greater humeral tuberosity or not)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144

Participant exclusion criteria

1. Patients suffering from voluntary and/or recurrent dislocation or reporting prior episode(s) of subluxation
2. Patients suffering from dislocation associated with 3- or 4-parts fracture of the proximal humerus
3. Patients with duration of dislocation greater than 24 hours
4. Intoxicated patients
5. Patients that had used any analgesics and/or muscle relaxants before attempting reduction

Recruitment start date

01/09/2006

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Greece

Trial participating centre

Third Orthopaedic Department
Thessaloniki
546 03
Greece

Sponsor information

Organisation

Aristotle University of Thessaloniki (Greece)

Sponsor details

Medical School
Bio-Ethics Committee
University Campus
Thessaloniki
541 24
Greece

Sponsor type

University/education

Website

http://www.med.auth.gr

Funders

Funder type

Hospital/treatment centre

Funder name

Aristotle University of Thessaloniki Medical School, Papageorgiou General Hospital, Third Orthopaedic Department (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes