To evaluate the cost-effectiveness the current ruling widespread Royal Dutch Physiotherapy Association guideline, in which the combined use of braces and proprioceptive training after ankle sprain treatment is advocated (usual care), against the use…
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Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures will be incidence of ankle sprain recurrences. An
economic evaluation will determine and compare the total costs for subjects in
all four trial arms, and to relate these costs to the effects of these groups.
The economic evaluation will be performed alongside the randomised controlled
trial and from a societal perspective.
Secondary outcome
Secondary outcome measures include recurrence severity, residual complaints,
and knowledge and attitude regarding the prevention of ankle sprain
recurrences.
Background summary
Ankle sprains are the most common sports and physical activity (PA) related
injury. It has been estimated that about 25% of all injuries across all sports
are ankle injuries. Of all ankle injuries 85% involve the lateral ankle
ligaments, i.e. acute lateral ankle sprains. There is extensive evidence that
there is an up to twofold increased risk for ankle re-injury during the first
year post- injury. A recent systematic review conducted by our research group,
revealed that both braces as well as proprioceptive training have been proven
equally effective for prevention of ankle sprains. This raises efficiency
questions regarding current usual care after an ankle sprain, as secondary
preventive costs can potentially be reduced simply by reducing the current
content of usual care.
Study objective
To evaluate the cost-effectiveness the current ruling widespread Royal Dutch
Physiotherapy Association guideline, in which the combined use of braces and
proprioceptive training after ankle sprain treatment is advocated (usual care),
against the use of braces and proprioceptive training as separate secondary
preventive measures.
Study design
Randomised Controlled Trial
A total of 357 participants is required at baseline. All analyses will be
carried out according to the intention-to-treat principle. Cox- regression
analysis will be used to compare ankle recurrence risk between the intervention
and control groups.
The proposed study will have a duration of 3 years and will start in January
2010. Recruitment will last 9 months until December 2010. Follow-up lasts
exactly 12 months for each subject, final measurements will take place in
December 2011.
Intervention
Subjects allocated to either the *usual care* or brace group will receive an
Aircast A60 ankle brace. They will be strongly advised to wear this ankle brace
during competition, as in the current ruling KNGF guideline. Subjects of either
the *usual care* or proprioceptive group will receive a standardized eight-week
proprioceptive training programme.
Study burden and risks
Participants will be asked to complete a questionnaire at baseline. Hereafter,
a short retrospective follow-up questionnaire will be completed each month. In
case of recurrent injury participants will complete an injury registration form
as well as an cost-diary.
Next to these measurements, participants randomised to the training group are
required to perform proprioctpeive exercises three times a week for a period fo
eight weeks. Participants in the brace group will be asked to wear a brace
during their regular sports activities.
Participants will not be at any risk. This concerns a comparative study on
proven preventive measures.
Van der Boechorststraat 7
1081BT Amsterdam
NL
Van der Boechorststraat 7
1081BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. sustained an acute lateral ankle ligament injury within 4 weeks before inclusion
2. are currently being (para)medically treated for that acute lateral ankle ligament injury
Exclusion criteria
Patients with an ankle fracture are excluded
Design
Recruitment
Medical products/devices used
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 | NL31785.029.10 |