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
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