Clinical trial NCT01259752: Compression Stockings in Ankle Sprain
Official title: Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankle Sprain
Keywords: Trauma
ankle sprain
emergency
compression stocking
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Pierre and Marie Curie University
name: Poitiers University Hospital
First posted: 2010-12-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Delay to recovery of normal painless walking, without any analgesic drug consumption.
timeFrame: up to 90 days
Secondary outcomes:
measure: Pain at rest using a visual analog pain scale
timeFrame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
measure: Bimalleolar perimeter
timeFrame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
measure: Number of days with analgesic drug consumption
timeFrame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
measure: Observance analysis
timeFrame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
measure: Delay to recover sport activities in the subgroup of patients having a regular sport activity
timeFrame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) and at the last follow-up visit (D-90)
measure: Pain during walking using a visual analog pain scale
timeFrame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
measure: middle-feet perimeter
timeFrame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpetriere hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre Hausfater, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.