Compression Stockings in Ankle Sprain (CASED)

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 Overview

• Status: Completed
• Conditions: Ankle Sprain
• Intervention / Treatment: Device: compression stockings; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitie Salpetriere Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: compression stockings	Device: compression stockings; compression stockings
Placebo Comparator: standard non compressive stockings	Other: standard non compressive stockings; standard non compressive stockings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Delay to recovery of normal painless walking, without any analgesic drug consumption.	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at rest using a visual analog pain scale		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Bimalleolar perimeter		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Number of days with analgesic drug consumption		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Observance analysis	Number of days actually wearing compression stocking and ankle bracing and taking analgesic drugs	at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Delay to recover sport activities in the subgroup of patients having a regular sport activity		at each follow-up visit (D-7, D-15 to 21, D-30 to 45) and at the last follow-up visit (D-90)
Pain during walking using a visual analog pain scale		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
middle-feet perimeter		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Poitiers University Hospital; Pierre and Marie Curie University
• Investigators: Principal Investigator: Pierre Hausfater, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Bendahou M, Khiami F, Saidi K, Blanchard C, Scepi M, Riou B, Besch S, Hausfater P. Compression stockings in ankle sprain: a multicenter randomized study. Am J Emerg Med. 2014 Sep;32(9):1005-10. doi: 10.1016/j.ajem.2014.05.054. Epub 2014 Jun 12.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: September 23, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 31, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: emergency; ankle sprain; Trauma; compression stocking
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: P080603