ObjectivesThe aim of this study is to measure if there is a significant difference in comfort, pain and recovery of function between treatment with a broad arm sling or a 2 points-sling in patients with a collarbone fracture, treated conservatively.…
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comfort of the immobilisation method is measured with the D-QUEST
Secondary outcome
Pain is measured with a visual analogue scale (VAS)
Recovery of function is measured with the DASH questionnaire
Background summary
Patients with a collarbone fracture who are treated conservatively at the
Reinier de Graaf Gasthuis (RdGG) receive treatment with a broad arm sling,
accordingly to the guidelines of trauma surgery (Trauma Regio West, 2016). This
guideline gives two options for the standard conservative treatment; the broad
arm sling and the 2 point-sling. As of now there is no literature available on
the difference between these two immobilisation methods.
The aim of this study is to measure if there is a significant difference in
comfort, pain and recovery of function between treatment with a broad arm sling
or a 2 points-sling in patients with a collarbone fracture, treated
conservatively.
Study objective
Objectives
The aim of this study is to measure if there is a significant difference in
comfort, pain and recovery of function between treatment with a broad arm sling
or a 2 points-sling in patients with a collarbone fracture, treated
conservatively.
Hypothesis
Our hypothesis gives better comfort and thereby less pain and sooner recovery
of function
Research question
Is there a significant difference between comfort, pain and recovery of
function during recovering of a collar bone fracture at adolescents and adults
with conservative treatment with a 2 points-sling or a broad arm sling?
Study design
A prospective stratified study at the Emergency Department of Reinier de Graaf
Gasthuis, single centre study.
Intervention
One group will receive a broad arm sling (Merk: BSN Medical, REF: 72139-12,
CE-nummer: 607662) the other group will receive a 2 point-sling (Merk: Klinion,
REF: 132590, CE-nummer: 607662).
Study burden and risks
Patient who participate in the study have to fill in a questionnaire. One time
at the ER visit and 3 times thereafter, at 1, 3, 6 weeks by mail or telephone.
Filling in the questionnaire will take about five to ten minutes.
We expect that the treatment with a 2 point-sling will give more comfort and
thereby possibly less pain and sooner recovery of function.
Patients enrolled in the study will not have additional risk.
Reinier de Graafweg 3
Delft 2625AD
NL
Reinier de Graafweg 3
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
- Age from 16 years
- Competent and adequate understanding of the Dutch language
- Conservative treatment of the fracture
- Acute fracture (<4 days old)
- Monotrauma
- Informed consent
Exclusion criteria
- Surgical treatment
- Fracture> 4 days old
- Pathological fracture
- Neuro-vascular abnormalities
- Multitrauma
- Familiar with shoulder complaints / condition with shoulders (eg rheumatism)
- Recurrent fracture
- Known pain syndrome or under treatment at outpatient pain clinic
- Epiphyse / metaphysis fracture
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL70984.058.20 |