Ankle treatment after injuries of the ankle ligaments

Inversion ankle sprains are very common problems in present health care. In
spite of a lot of published reports concerning treatment of ankle injuries,
still no definite conclusions concerning the most optimal treatment strategy
can be drawn. Current evidence supports the view that a functional treatment
strategy is preferable, but insufficient data is present to prove a surplus
value of the addition of external support. Possible described disadvantages of
external support devices are just acceptable when benefits of this treatments
have been proven. Hypothesis of our study is that a functional therapy
supplemented by external ankle support will not show statistically significant
better results than a purely functional treatment strategy in management of
acute ankle sprains.

Objective of the ANKLE TRIAL is to differentiate between results of three types
of functional treatment in a profound methodological way, with primary research
question: what will be the optimal functional treatment for acute lateral ankle
ligament injuries: is there any surplus value of external support devices (tape
or brace) in comparison with a purely functional treatment strategy?
Furthermore, we want to investigate the influence of gravity of the ankle
sprain or degree of sports intensivity in determining which therapy is to
prefer.

Prospective, open randomised controlled trial

After inclusion patients are randomised in 3 treatment groups, which will all
been treated functionally (physical therapy) next to:
1 - intervention group: pressure bandage and tape
2 - intervention group: pressure bandage and brace (AirLoc®, Bauerfeind)
3 - control group: no way of external support at all

Patients are proposed to several questions and will undergo short physical
examination in the time of inclusion (scoring moment 1), after 5 to 7 days and
after 6 weeks (respectively scoring moment 2 and 3). Furthermore they will the
be phoned up for an interview after 6 months and possibly they will be asked
for anamnesis and examination after 1 year. Estimated extended burden in
comparison of current standard treatment and follow up: 1 or 2 extra hospital
visits, depending on the randomised treatment (change of tape requires an extra
hospital visit). In our opinion the risks for the participating patients will
be small, because we estimate that there do not exist big result differences
between the three investigated treatment strategies.