Ankle treatment after injuries of the ankle ligaments

Inversion ankle sprains are very common problems in present health care. In
spite of a huge mount 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
the 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 activities 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 - no external support at all
2- pressure bandage and tape
3 - pressure bandage and brace (AirLoc®, Bauerfeind)

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 large result differences
between the three investigated treatment strategies.