Background: Acute lateral ankle ligament injuries are very common problems in present health care. Still there is\r\nno hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional\r\ntreatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in\r\nthese types of treatment. The hypothesis of our study is that external ankle support devices will not result in better\r\noutcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall\r\nobjective is to compare the results of three different strategies of functional treatment for acute ankle sprain,\r\nespecially to determine the advantages of external support devices in addition to functional treatment strategy,\r\nbased on balance and coordination exercises.\r\nMethods/design: This study is designed as a randomised controlled multi-centre trial with one-year follow-up.\r\nAdult and healthy patients (N = 180) with acute, single sided and first inversion trauma of the lateral ankle\r\nligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3\r\ntreatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support.\r\nPrimary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales), number of\r\nrecurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured\r\nafter one week, 6 weeks, 6 months and 1 year.\r\nDiscussion: The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group,\r\nwithout any external support is investigated. Results of this study could lead to other opinions about usefulness of\r\nexternal support devices in the treatment of acute ankle sprain.
Loading....