title: Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial.
abstract: BACKGROUND
  Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains.
  
  
  METHODS
  60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D.
  
  
  CONCLUSIONS
  This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various neuromuscular parameters, WBV is a promising treatment method for patients with acute unstable inversion ankle sprains.
  
  
  BACKGROUND
  NCT01702597.
authors: Department of Surgery, Campus Innenstadt, Ludwig-Maximilians-University, Munich, Germany.
authors: Sebastian Felix
authors: SF
authors: Baumbach
authors: Mariette
authors: M
authors: Fasser
authors: Hans
authors: H
authors: Polzer
authors: Michael
authors: M
authors: Sieb
authors: Markus
authors: M
authors: Regauer
authors: Wolf
authors: W
authors: Mutschler
authors: Matthias
authors: M
authors: Schieker
authors: Michael
authors: M
authors: Blauth
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D016512:Ankle Injuries / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D000843:Ankle Joint / Q000503:physiopathology*; D001696:Biomechanical Phenomena; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D005081:Exercise Therapy; D005858:Germany; D006801:Humans; D007593:Joint Instability / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D009989:Orthotic Devices; D010147:Pain Measurement; D004856:Postural Balance; D020127:Recovery of Function; D012107:Research Design; D013180:Sprains and Strains / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014732:Vibration / Q000627:therapeutic use*; D055815:Young Adult