Reduction of the anterior shoulder dislocation with three different methods

ISRCTN ISRCTN80984121
DOI https://doi.org/10.1186/ISRCTN80984121
Secondary identifying numbers N/A
Submission date
28/01/2009
Registration date
27/02/2009
Last edited
27/02/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Fares Sayegh
Scientific

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

Study information

Study designProspective parallel-group randomised controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe new FARES (FAst REliable Safe) method of reduction of the acute anterior dislocation of the shoulder: a prospective randomised comparative study
Study objectivesAnterior 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(s)Scientific and Ethical Committee, Papageorgiou General Hospital of Thessaloniki, approved on 29/09/2008.
Health condition(s) or problem(s) studiedTraumatic shoulder dislocation
InterventionParticipants 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 typeOther
Primary outcome measureEfficacy 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 measures1. 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 study start date01/09/2006
Completion date01/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants144
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/09/2006
Date of final enrolment01/06/2008

Locations

Countries of recruitment

  • Greece

Study participating centre

Third Orthopaedic Department
Thessaloniki
546 03
Greece

Sponsor information

Aristotle University of Thessaloniki (Greece)
University/education

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

Website http://www.med.auth.gr
ROR logo "ROR" https://ror.org/02j61yw88

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan