To examine the effectiveness of an unsupervised e-health supported neuromuscular training program in combination with usual care in general practice compared to usual care alone in patients with acute lateral ankle sprains in general practice.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a) The total number of re-sprains reported after 1-year follow-up.
A re-sprain is defined as *an ankle sprain occurring as a result of sports
participation or other daily activities and which cause one or more of the
following:
1. The subject has to stop the sports activity; and/or
2. Cannot (fully) participate in the next planned sports activity; and/or
3. Cannot go to work/school the next day; and/or
4. Needs medical attention (ranging from onsite care by e.g. GP, to personal
care by e.g. sports physician
Secondary outcome
a) Subjective recovery after 1-year follow-up, measured on a 7-point Likert
scale ranging from *completely recovered* to *worse than ever*. Patients are
deemed to be recovered if they rate themselves as *fully recovered* or
*strongly recovered* on the Likert scale, whereas those who rate themselves as
*slightly recovered* to *worse than ever* are deemed to be not recovered.
b) Pain at rest and during activity (NRS)
c) Function (AFS)
d) Return to sport
e) Cost-effectiveness of the intervention
f) Compliance of the intervention: Subjects are defined to be compliant to the
intervention when they have completed at least 75% of the training sessions.
Background summary
Ankle sprains are the most frequent traumas of the musculoskeletal system, with
yearly around 650.000 new sprains in the Netherlands. Of these, about 130.000
people will visit the general practitioner (GP) each year. The Dutch
NHG-guideline summarizes the evidence on the potential treatments for acute
ankle sprains; however there is very little guidance for treatment. No optimal
treatment modality has proven to be effective in general practice.
Study objective
To examine the effectiveness of an unsupervised e-health supported
neuromuscular training program in combination with usual care in general
practice compared to usual care alone in patients with acute lateral ankle
sprains in general practice.
Study design
Multi-centre open labeled randomized trial with a follow-up of 12 months
Intervention
The intervention group will receive a standardized eight-week neuromuscular
training program guided by an App, in addition to the usual care. The control
group will receive usual care in general practice alone.
Study burden and risks
There are no risks associated with participation. All patients included in our
study will receive the usual care according to the clinical guideline. The only
tests that are used are questionnaires, which will take about 10 minutes each
to fill in every month. Altogether this will take the patient approximately 2
hours over a period of 1 year. The questionnaires that are used are not
associated with physical or physiological discomfort.
In the intervention group, patients will most likely benefit from the used
neuromuscular training program in our study, since it can reduce persistent
complaints and re-sprains
Laan van Nieuw Oost-Indië 334
Den Haag 2593 CE
NL
Laan van Nieuw Oost-Indië 334
Den Haag 2593 CE
NL
Listed location countries
Age
Inclusion criteria
- Patients with an acute lateral ankle sprain and visit the general practitioner within three weeks of injury
- Between 14 and 65 years
- Informed consent
Exclusion criteria
- A history of an injury of the same ankle during the previous year
- A history of a fracture of the same ankle
- No understanding of Dutch language.
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 | NL48615.078.14 |