Compression Stockings in Ankle Sprain (CASED)
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|ClinicalTrials.gov Identifier: NCT01259752|
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : July 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ankle Sprain||Device: compression stockings Other: standard non compressive stockings||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Experimental: compression stockings||
Device: compression stockings
|Placebo Comparator: standard non compressive stockings||
Other: standard non compressive stockings
standard non compressive stockings
- Delay to recovery of normal painless walking, without any analgesic drug consumption. [ Time Frame: up to 90 days ]
- Pain at rest using a visual analog pain scale [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ]
- Bimalleolar perimeter [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ]
- Number of days with analgesic drug consumption [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ]
- Observance analysis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ]
- middle-feet perimeter [ Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259752
|Pitié Salpetriere hospital|
|Paris, France, 75013|
|Principal Investigator:||Pierre Hausfater, MD, PhD||Assistance Publique - Hôpitaux de Paris|