Which BRT or combination of BRT is the fastest, least painful, has the lowest complication rate and gives the highest patient satisfaction for adult patients with an anterior shoulder dislocation presenting in the emergency department?
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- length of ED stay in minutes, defined as the moment of arrival at the ED
until the patient is discharged
- levels of pain experienced by patient before, during and after reduction,
measured by NRS (Numeric rating scale (0-10)
Secondary outcome
- Time needed for reduction in minutes from start until end of reduction
- Numbers of techniques used for reduction
- Use of analgesia and/or sedatives (which and dosage), pre-hospital and/or in
hospital administered
- Pre-reduction status of osseous (x-ray) and neurovascular (physical exam) of
the shoulder
- Iatrogenic complications (osseous or neurovascular)
- Age, gender, ASA classification, last meal (2,4,6 hours, type of meal)
- First episode or recurrent dislocation
- Trauma mechanism
Background summary
Shoulder dislocations are one of the most common dislocations in an emergency
department (ED). Shoulder dislocations are very painful and need direct
intervention to minimize discomfort and potential tissue damage (cartilage,
nerve and vascular). Reposition techniques are divided in three groups:
traction based (e.g. Hippocrates), leverage (e.g. Kocher) or biomechanical
techniques (e.g. Cunningham). Common practice are traction or leverage based
techniques which have proven to be successful in shoulder repositioning.
However, these techniques do not meet the requirements of quick, painless or
complication less reposition. They do not focus on patient satisfaction and the
prevention of emergency department crowding. Because of these limitations we
have looked in the literature for other techniques and based this search we
have found that biomechanical reposition techniques (BRT) do fulfil these
requirements. However it is not clear from the literature what the fastest or
least painful BRT or combination of BRT is.
Study objective
Which BRT or combination of BRT is the fastest, least painful, has the lowest
complication rate and gives the highest patient satisfaction for adult patients
with an anterior shoulder dislocation presenting in the emergency department?
Study design
A randomized multicenter trial.
Intervention
Depending on ability to adduct subjects will be randomized for biomechanical
repositioning according to Cunningham, Modified Milch or Scapular manipulation
technique and Modified Milch or Scapula manipulation technique.
Study burden and risks
All non-biomechanical techniques are based on traction or leverage and are
therefore inherently painful and potentially harmful. The biomechanical
techniques used in this study are more physiological and are less painful. No
adverse events are described in the biomechanical reduction techniques.If the
biomechanical reduction techniques fail and the treating physician will
subsequently use another technique, more time will be needed for reduction. In
that case procedure time will not differ compared to a traction or leverage
based technique because of the usual set up time for sedation, analgesia and
monitoring used with the traditional techniques.
Hospitaalweg 1
Almere 1315 RA
NL
Hospitaalweg 1
Almere 1315 RA
NL
Listed location countries
Age
Inclusion criteria
all, legally competent, adult subjects (*18 years) with an isolated anterior shoulder dislocation
Exclusion criteria
- subcapital humeral fractures
- multi trauma
- subclavicula-, thoracic- , inferior or posterior dislocation
- dislocations presented after 24 hours.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54173.094.15 |
| OMON | NL-OMON20640 |