Compression Stockings in Ankle Sprain

Ankle Sprain Clinical Trial

— CASED  

Official title:

Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259752
• Other study ID #: P080603
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2010
• Last updated: July 30, 2012
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Device:
• compression stockings
compression stockings

Other:
• standard non compressive stockings
standard non compressive stockings

Locations

Country	Name	City	State
France	Pitié Salpetriere hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Pierre and Marie Curie University, Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay to recovery of normal painless walking, without any analgesic drug consumption.		up to 90 days	No
Secondary	Pain at rest using a visual analog pain scale		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)	No
Secondary	Bimalleolar perimeter		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)	No
Secondary	Number of days with analgesic drug consumption		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Pain during walking using a visual analog pain scale		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)	No
Secondary	middle-feet perimeter		at each follow-up visit (D-7, D-15 to 21, D-30 to 45)	No