Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ankle mobility
研究概览
简要总结
The study consists in recruiting patients with ankle sprains who visit the emergency department (ED).
Each patient will be tested by an osteopath who we will measure pain, swelling and/or edema, and mobility of the ankle. Patients will be asked to reproduce exercises such as to hold on one foot, to stand on tiptoes...
Then, patients will be divided into two groups. The first group will undergo medical treatment during the ED visit, while the second group will undergo osteopathic treatment.
Three time points will be planned. The first one will be the patient's consultation in the ED where treatment will be carried out according to its assignment, as well as the clinical measures previously described. The second time point will be seven days later (plus or minus three days), where only clinical measurements will be performed. The third time point will be three weeks later (plus or minus three days), when the ankle sprain has consolidated, in order to carry out the clinical measurements again.
These clinical measurements will allow to evaluate the effectiveness of a single osteopathic consultation in the ED. The investigators expect a reduction in immediate pain, and thereafter, a reduction in swelling, and an improved mobility and stability of the ankle.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Unilateral sprain
- •Stage 1 or 2 sprain
- •Recent sprain < 72 hours
- •With or without the presence of edema and/or hematoma
- •Receiving prior consultation from an ED physician
- •Understanding French
- •Agreeing to participate in the study and having signed the consent form
- •Patient affiliated to a social security schem
排除标准
- •Fractured foot, tibia, fibula
- •Stage 3 ankle sprain
- •Operated sprain
- •Current use of drugs/alcohol
- •Altered mental state
- •Chronic ankle injury on the contralateral side
- •Person deprived of liberty by a judicial or administrative decision
- •Neoplasia
- •Any contraindication to osteopathy
研究组 & 干预措施
Osteopathic treatment / Usual care
osteopathic treatment will be applied in this intervention group.
干预措施: Medical treatment (Other)
Osteopathic treatment / Usual care
osteopathic treatment will be applied in this intervention group.
干预措施: osteopathic treatment (Other)
Usual care
Classic medical treatment
干预措施: Medical treatment (Other)
结局指标
主要结局
Ankle mobility
时间窗: Week 3
measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one
次要结局
未报告次要终点
