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临床试验/NCT04999254
NCT04999254
已完成
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Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain : a Randomized Controlled Trial

CHU de Reims1 个研究点 分布在 1 个国家目标入组 50 人2021年11月28日

概览

阶段
不适用
干预措施
Medical treatment
疾病 / 适应症
Ankle Sprains
发起方
CHU de Reims
入组人数
50
试验地点
1
主要终点
Ankle mobility
状态
已完成
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2021年11月28日
结束日期
2022年9月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
CHU de Reims
责任方
Sponsor

入排标准

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

Osteopathic treatment / Usual care

osteopathic treatment will be applied in this intervention group.

干预措施: osteopathic treatment

Usual care

Classic medical treatment

干预措施: Medical treatment

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

研究点 (1)

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