Compression Stockings in Ankle Sprain

Phase 3

Completed

• Conditions: Ankle Sprain
• Interventions: Device: compression stockings; Other: standard non compressive stockings

• Registration Number: NCT01259752
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-06
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compression stockings	compression stockings	-
standard non compressive stockings	standard non compressive stockings	-

Primary Outcome Measures

Name	Time	Method
Delay to recovery of normal painless walking, without any analgesic drug consumption.	up to 90 days

Secondary Outcome Measures

Name	Time	Method
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	at each follow-up visit (D-7, D-15 to 21, D-30 to 45)	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	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)

Trial Locations

Locations (1)

Pitié Salpetriere hospital; 🇫🇷 Paris, France