Compression Stockings in Ankle Sprain

NCT ID: NCT01259752

Last Updated: 2012-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

Ankle Sprain

Keywords

Trauma; ankle sprain; emergency; compression stocking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

compression stockings

Group Type: EXPERIMENTAL

compression stockings

Intervention Type: DEVICE

compression stockings

standard non compressive stockings

Group Type: PLACEBO_COMPARATOR

standard non compressive stockings

Intervention Type: OTHER

standard non compressive stockings

Interventions

compression stockings

compression stockings

Intervention Type: DEVICE

standard non compressive stockings

standard non compressive stockings

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre and Marie Curie University

OTHER

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Hausfater, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Pitié Salpetriere hospital

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25043629 (View on PubMed)

Other Identifiers

P080603

Identifier Type: -

Identifier Source: org_study_id