If the study shows that the treatment with a sling gives an earlier return to normal function en does not give a clinically significant difference in pain experience compared to cast therapy than the traditional treatment can be adjusted. We aim at…
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Painscore (VAS 1-100): mean score day 1-4
Secondary outcome
- Painscore (VAS 1-100): mean score first week (day 1-7) and after 2 weeks.
- Wrist function with a questionnaire (0-100).
The Acitvities Scale for Kids is a validated questionnaire that has been
translated [11-12]. The first questionnaire is collected at the ED and concerns
the 3 previous days before the EDvisit. Other questionnaires will be collected
after 1 and 2 weeks. Every questionnaire concerns the 3 previous days.
- Range of motion with goniometer (dorso- and volarflexion of the left and
right wrist)
- Gripstrength (Power (kg) of the left and right hand)
The range of motion and gripstrength will be performed in the ED and after 1
and 2 weeks in the outpatient clinic.
Additional variables
- Use of pain medication (tablets/day)
- Discomfort (itching, too heavy, too tight, too wide, other complaints)
- Comfortability of the treatment (5 point scale: very comfortable to very
uncomfortable)
- Satisfaction of the treatment (5 pointscale: very satisfied to very
unsatisfied)
Background summary
Torus fractures of the wrist are a common injury amongst children. It is a very
simple fracture, that can easily be missed during clinical examination. An
X-ray will show a buckle on te cortex of the bone. Traditionally, these simple
and stable fractures are treated with a below the elbow short arm cast.
Recent studies have considered looking at treatment alternatives. These studies
showed that this stable fracture does not need long term immobilsation in a
cast, and that treatment with soft bandages and removable splints is a safe
alternative with many benefits [1-5, 10]. S. Gryllis Allison mentioned that
treatment with only a mitella and no furthur immobilsation will be enough,
because the fracture is stable and studies have shown that the use of support
bandages is of little of no use in promoting stability and encouraging
recovery. Watts and Armstrong found that the use of support bandages does not
reduce recovery time and may increase the need for analgesia in EDs [6].
Studies have shown that treatment with soft bandages or removable splints is
more comfortable and that a quicker return to normal function is achieved in
comparison with cast therapy [1-5, 10]. In the study of West et al. 95% of the
bandage patients were able te move their wrists during the fourth day and all
patiënts were using the wrist during the second week. De cast patiënts were not
able to move or use the wrist until the fourt week. Concerning pain two bandage
studies contradict eachother. The bandage group of West et al. had less pain
and the duration of pain was shoter than that of the cast group (22% during 1-2
days versus 71% during 2-5 days). The bandage group of Kropman et al
experienced more pain during the first week than the cast group, but this
difference was not clinically significant (mean VAS 26 versus 20). A VAS 10-15
points difference on a 100 point scale is clinically significant [7-9].
A limitation of both studies of Kropman and West is that they defined function
by volar and dorsal flexion. It is more complete to add also gripfunction and a
functionquestionnaire. Also the timing of functionmeasurement (after 4 and 6
weeks) is not ideal. It is more interesting to measure after 1 and 2 weeks and
finally after 6 weeks. The last limitation of Kropman is that the treatment
given is longer than standard. The patiënts were ginving a cast of pressure
bandage for 4 weeks. In our hospital the mean duration of treatment is 12 days.
Another limitation of the study of West is the small amount of patients and
the lack of a sample size calculation.
Also the painresults are questionable. They acsertained pain or no pain. They
did not grade the pain. 78% of the pressure bandage and 28% of the cast
patients experienced no pain during the first week. This seems unlikely when
compared to the results of Kropman and Plint.
In our study we want to compare mitella therapy with cast therapy. This study
has not been performed previously. It will test the theory that torus fractures
are stable and that only symptomatic treatment is required. We expect that
mitella therapy is more comfortable, gives earlier return to normal function en
does not give a difference in pain experience compared to cast therapy.
When our theory is correct, than this will have considerable economic
implications by money to be saved in terms of time and resource management.
Literature
1. S. West et al. Buckle fractures of the distal radius are safely treated in a
soft bandage. A randomized prospective trial of bandage versus plaster cast. J.
Pediatr. Orthop. Volume 25, Number 3, May/June 2005, Pag. 322-325.
2. J.S Davidson et al. Simple treatment for torus fractures of the distal
radius. The Journal of bone en joint surgery (Br). Volume 83-B. No 8. November
2001. Pag. 1173-1175.
3. F. Firmin and R Crouch. Splinting vs casting of *torus*fractures tot the
distal radius in the paediatric patient presenting at the emergency department
(ED): literature review. International Emergency Nursing. 17, 2009, 173-178.
4. S. Grylls Allison. Paediatric torus fracture. Emergency Nurse. Vol 16. No 6.
October 2008, 22-25.
5. H.J. Kropman et al. Treatment of impacted greenstick forearm fractures in
children using bandage or cast therapy: a prospective randomized trial. The
journal of trauma, injury, infection, and critical care. Volume XX, Number XX,
XXX 2009.
6. B. Watts and B Armstrong. A randomised control trial to determine the
effectiveness of double Tubigrip in grade 1 & 2 mild-moderate ankle sprains.
Emergency medicine journal. 2006. 18. 46-50.
7. Powel CV et al. Determining the minimum clinically significantdifference in
visual analog pain score for children. Ann. Emerg. Med. 2001;37:28-31
8. Todd KH et al.Clinical significance of reported changes in pain severity.
Ann Emerg Med. 1996;27:485-489
9. Kelly AM. The minimum clinically significant difference in visual analogue
pain score does not differ with severity of pain. Emerg. Med. J. 2001;18:205-207
10. Plint A.C. et al. A randomized, controlled trial of removable splinting
versus casting for wrist buckle fractures in children. Pediatrics. Volume 117,
number 3, march 2006, 691-697.
11. Plint AC. Activities scale for kids, an anakysis of normals.J Pediatr
Ortop. 2003; volume 23, number 6, 788-790.
12. Young NL. Measurement properties of the activities scale for kids. Journal
of clinical epidemiology. 2000. Number 53, 125-137
Study objective
If the study shows that the treatment with a sling gives an earlier return to
normal function en does not give a clinically significant difference in pain
experience compared to cast therapy than the traditional treatment can be
adjusted. We aim at contributing to a national or international guideline in
the future.
It is a non-inferiority study. This means that the children from the slinggroup
are allowed te have a little bit more pain than the castgroup if their return
to normal function is faster. They are not allowed to have clinically
significant more pain than the cast group. This means a difference of 10-15
point on a 100-pointscale. If there is a clinically significant difference in
pain, than the standard casttreatment will not be changed.
Study design
Randomized controlled trial (RCT), open
Intervention
Randomisation into 2 groups:
A. Sling
B. Cast + sling
Study burden and risks
There are no risks involved in this study. Both therapies are save. There are
no invasive tests. Patients return 1 or 2 times at the outpatient clinic during
the traditional cast therapy, every visit has an estimated duration of 15
minutes. In the study context we expect these visits to last 30 minutes.
Lijnbaan 32
's-Gravenhage 2512 VA
NL
Lijnbaan 32
's-Gravenhage 2512 VA
NL
Listed location countries
Age
Inclusion criteria
Children 5 to 15 years old with:
- A torus fracture of the distal radius
Exclusion criteria
Children with:
- Greenstick fractures
- Torus antebrachii fractures
- Children with an additional fracture(s)
- Children with a metabolic bone disease
- Children with special needs
- Language barrier
- Children living in another region and therefore are followed-up in another hospital
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL30801.098.10 |