title: The ANKLE TRIAL (ankle treatment after injuries of the ankle ligaments): what is the benefit of external support devices in the functional treatment of acute ankle sprain? A randomised controlled trial.
abstract: BACKGROUND
  Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises.
  
  
  METHODS
  This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180) with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales), number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year.
  
  
  CONCLUSIONS
  The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain.
  
  
  BACKGROUND
  Netherlands Trial Register (NTR): NTR2151.
authors.affiliation: Department of surgery, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ 's-Hertogenbosch, The Netherlands. suzanne.witjes@gmail.com
authors.forename: Suzanne
authors.initials: S
authors.lastname: Witjes
authors.forename: Femke
authors.initials: F
authors.lastname: Gresnigt
authors.forename: Michel P J
authors.initials: MP
authors.lastname: van den Bekerom
authors.forename: Jan G
authors.initials: JG
authors.lastname: Olsman
authors.forename: Niek C
authors.initials: NC
authors.lastname: van Dijk
mesh_terms: D000328:Adult; D016512:Ankle Injuries / Q000503:physiopathology* / Q000628:therapy*; D018771:Arthralgia / Q000503:physiopathology / Q000628:therapy; D001915:Braces / Q000592:standards*; D005500:Follow-Up Studies; D006801:Humans; D007593:Joint Instability / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D017844:Lateral Ligament, Ankle / Q000293:injuries* / Q000503:physiopathology; D010147:Pain Measurement / Q000379:methods; D012107:Research Design; D013180:Sprains and Strains / Q000503:physiopathology / Q000628:therapy*