Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Delay to recovery of normal painless walking, without any analgesic drug consumption.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent (<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years.
排除标准
- •Patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women
研究组 & 干预措施
standard non compressive stockings
干预措施: standard non compressive stockings (Other)
compression stockings
干预措施: compression stockings (Device)
结局指标
主要结局
Delay to recovery of normal painless walking, without any analgesic drug consumption.
时间窗: up to 90 days
次要结局
- 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))