Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Delay to recovery of normal painless walking, without any analgesic drug consumption.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
standard non compressive stockings
Intervention: standard non compressive stockings (Other)
compression stockings
Intervention: compression stockings (Device)
Outcomes
Primary Outcomes
Delay to recovery of normal painless walking, without any analgesic drug consumption.
Time Frame: up to 90 days
Secondary Outcomes
- 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))
- 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))