Compression Stockings in Ankle Sprain (CASED)

This study has been completed.
Sponsor:
Collaborators:
Pierre and Marie Curie University
Poitiers University Hospital
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01259752
First received: September 23, 2010
Last updated: July 30, 2012
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Ankle Sprain
Device: compression stockings
Other: standard non compressive stockings
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Delay to recovery of normal painless walking, without any analgesic drug consumption. [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome 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) ] [ Designated as safety issue: No ]
  • Bimalleolar perimeter [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ] [ Designated as 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) ] [ Designated as safety issue: No ]
  • Observance analysis [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ] [ Designated as safety issue: No ]
    Number of days actually wearing compression stocking and ankle bracing and taking analgesic drugs

  • 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) ] [ Designated as 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) ] [ Designated as safety issue: No ]
  • middle-feet perimeter [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: compression stockings Device: compression stockings
compression stockings
Other Name: compression stockings
Placebo Comparator: standard non compressive stockings Other: standard non compressive stockings
standard non compressive stockings
Other Name: standard non compressive stockings

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259752

Locations
France
Pitié Salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Pierre and Marie Curie University
Poitiers University Hospital
Investigators
Principal Investigator: Pierre Hausfater, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01259752     History of Changes
Other Study ID Numbers: P080603
Study First Received: September 23, 2010
Last Updated: July 30, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Trauma
ankle sprain
emergency
compression stocking

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014