The aim of this feasibility study is to define whether one week of plaster cast treatment is possible and can lead to better functional results, with at least the same patient satisfaction and complications. This feasibility study will be used to…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter in this study will be the patient reported outcome
(PRO) measured with the patient reported wrist evaluation (PRWE) questionnaire.
Secondary outcome
1. In addition to the PRWE, we will use the DASH questionnaire for upper
extremity functioning. The two questionnaires will be measured after six weeks
and three, six and twelve months. Comprehensive PRO measures will also be
measured. This a more generic instrument that captures aspects of health status
and quality of life beyond hand functioning. The Short Form * 36 (SF-36) will
be used to measure this.
2. Complications. The complication checklist for DRF from McKay will be used
for scoring the complications after a DRF. The clinical record, questions by
interview and questionnaires will be used to complete the checklist. The
Budapest diagnostic criteria will be used to score CRPS, a complication which
can occur after a DRF. In addition, pain and post traumatic pain will be
scored. The visual analogue scale (VAS) will be asked and the PROMIS pain
interference questionnaire will be used for pain interference and diagnosing
post traumatic pain.
3. Process evaluation. The evaluation will be focused on:
- Willingness of participants. Every patient who can be included in the study
will be analyzed. Patients who did not want to be included are asked what their
reasons are.
- Acceptability of the study. Participants will be asked to give feedback on
study design and give their reaction to the intervention. This will be asked at
12 months* follow-up.
- Process evaluation. The study design will be evaluated afterwards. This
includes, evaluation of inclusion process, the intervention and follow-up with
questionnaires (response rates, adherence/compliance rates, etc) [Arain, 2010].
Background summary
Distal radius fracture (DRF) is a common fracture of which the incidence
appears to be increasing worldwide. On average, a total of 17% of all diagnosed
fractures are DRF*s.
In the Dutch guideline for DRF the treatment advice for DRF, without reduction,
is treatment with plaster cast or brace for one-three weeks. Despite the advice
in the guideline and despite several studies from the 90*s showing that plaster
cast treatment of a stable DRF for one week is safe, the usual length of
plaster cast treatment for stable DRF is four-six weeks. In addition, recent
studies have also shown that a long period of immobilization can lead to more
post traumatic pain by increasing disuse and kinesiophobia.
This evidence suggests that the usual duration (4-6 weeks) of plaster cast
treatment for DRF is unnecessary.
Study objective
The aim of this feasibility study is to define whether one week of plaster cast
treatment is possible and can lead to better functional results, with at least
the same patient satisfaction and complications. This feasibility study will be
used to define the sample size of the future RCT.
Study design
The present study is an open multi centre randomized clinical feasibility trial
for treatment of a DRF with one week versus four-five weeks of plaster cast.
Intervention
Patients will be included at emergency room. After one week they will be
randomized for the intervention or control group. The patients in the
intervention group follow the same protocol as the conventional group but
instead of four-five weeks of plaster cast the patients will be treated for one
week with a plaster cast. After another three-four weeks, patients will be seen
by the casting nurse for a quick control.
Study burden and risks
For patients in this study the burden to participate is minimal. Patients need
to fill in the different questionnaires and if necessary are called by the
investigator for further explanation. No extra visits to the hospital are
necessary.
In addition, the risk for the patient is negligible. A shorter immobilization
has been proved to be safe. Displacement of the fracture is minor and gives no
significant difference with longer plaster cast treatment. However, studies
also show that patients who were treated without plaster cast showed more pain
in the first week. This is the reason why we give patients plaster cast for 1
week and reduce the risk of having pain. The benefit is that patients will
mobilize the wrist faster, functional result will be better, work can be done
quicker and a shorter period of plaster cast will be given which leads to less
complications caused by long immobilization.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 75 years.
Isolated acute distal radius fracture
Closed reduction is not performed
Non-operative treatment with cast immobilisation
Understanding of Dutch language
Exclusion criteria
under the age of 18 or older than 75 years
multiple injured patient
reduction is indicated/performed
operative treatment
cognitive disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59217.091.17 |