Compression Stockings in Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter prospective randomized superiority controlled trial comparing leg
      stockings and standard care to standard care of ankle sprain and testing the hypothesis that
      compression stockings enable to reduce the median of recovery from ankle sprain by at least 6
      days.
    

Detailed description: 
      Introduction: Ankle sprain is a frequently encountered trauma lesion in emergency departments
      and is associated with important health expenses. However, appropriate care of this trauma
      lesion remains a matter of debate.

      Hypothesis: The tested hypothesis is that compression stockings enable to reduce the median
      of recovery from ankle sprain by at least 6 days.

      Main end point: Delay to recovery of normal painless walking, without any analgesic drug
      consumption.

      Secondary end points : Pain at rest and during walking using a visual analog pain scale,
      bimalleolar and middle-feet perimeters, number of days with analgesic drug consumption,
      observance analysis, patient's tolerance using a visual analog scale, delay to recover sport
      activities in the subgroup of patients having a regular sport activity.

      Methods: Multicenter Prospective randomized superiority controlled trial comparing leg
      stockings and standard care to standard care of ankle sprain. Standard care include the RICE
      (Rest, Ice, Compression, Elevation) protocol at admission, immobilization with ankle bracing
      (3 to 6 week duration according to severity and clinical course), recommendation for walking
      (no weight baring, partial weight bearing, total weight bearing), administration of analgesic
      drugs. The medical device tested in the present study is class II compressive stockings
      (compression between 15 and 20 mmHg).

      Number of patients: With an alpha risk of 5%, a beta risk of 5%, 70 patients should be
      included in each group to be able to detect a 6 day difference in the delay of recovery,
      defined as normal painless walking without any analgesic drug consumption, taking into
      consideration 10% of patients lost during follow up.

      Criteria for inclusion: Recent (<48h) ankle sprain without fracture and without other
      traumatic lesions in adult patients aged between 18 and 55 years. Patients with limb arterial
      disease, diabetes, or any diseases expected to potentially interfere with recovery of
      walking, are excluded as well as pregnant women.

      Study schedule: Inclusion during first visit to the emergency department, then at day 7,
      15-21, 30-45, and 90. Phone call interviews are performed to define the more appropriate
      timing of the visits.
    

Intervention name(s): compression stockings; standard non compressive stockings
Intervention type(s): Device; Other
Intervention description(s): compression stockings; standard non compressive stockings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trauma; ankle sprain; emergency; compression stocking