Compression Stockings in Ankle Sprain

Brief Summary

Official Title: “Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Device: compression stockings
    • compression stockings
  • Other: standard non compressive stockings
    • standard non compressive stockings

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: compression stockings
  • Placebo Comparator: standard non compressive stockings

Outcome Measures for this Clinical Trial

Primary Measures

  • Delay to recovery of normal painless walking, without any analgesic drug consumption.
    • Time Frame: up to 90 days
      Safety Issue?: No

Secondary Measures

  • Pain at rest using a visual analog pain scale
    • Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
      Safety Issue?: No
  • Bimalleolar perimeter
    • Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
      Safety Issue?: No
  • Number of days with analgesic drug consumption
    • Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
      Safety Issue?: No
  • Observance analysis
    • Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
      Safety Issue?: No
  • Delay to recover sport activities in the subgroup of patients having a regular sport activity
    • Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) and at the last follow-up visit (D-90)
      Safety Issue?: No
  • Pain during walking using a visual analog pain scale
    • Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
      Safety Issue?: No
  • middle-feet perimeter
    • Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Recent (<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years.

Exclusion Criteria

  • Patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Pierre and Marie Curie University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pierre Hausfater, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01259752