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
Scientific
Third Orthopaedic Department
Papageorgiou General Hospital
Ring-Road, N
Efkarpia
Thessaloniki
546 03
Greece
Study information
| Study design | Prospective parallel-group randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The new FARES (FAst REliable Safe) method of reduction of the acute anterior dislocation of the shoulder: a prospective randomised comparative study |
| Study objectives | 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(s) | Scientific and Ethical Committee, Papageorgiou General Hospital of Thessaloniki, approved on 29/09/2008. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2006 |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 144 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- Greece
Study participating centre
Third Orthopaedic Department
Thessaloniki
546 03
Greece
546 03
Greece
Sponsor information
Aristotle University of Thessaloniki (Greece)
University/education
University/education
Medical School
Bio-Ethics Committee
University Campus
Thessaloniki
541 24
Greece
| Website | http://www.med.auth.gr |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
