Skip to main content
OpenTrials
Completed

NCT Number: NCT04999254

Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Apyretic
  • Patient affiliated to a social security schem

Exclusion criteria

  • 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

Treatment and study plan

Medical treatment

Other

Medical treatment will be based on functional treatment and the doctor will prescribe the RICE protocol. For this, the patient will have to :

  • place an ice pack on the sprain
  • apply sports rest for three weeks
  • compress the sprain with a compression stocking when standing in order to prevent phlebitis. In addition, to avoid this complication, the doctor will prescribe an anticoagulant.
  • raise the foot with crutches during the day
  • elevate the foot at night or when doing an activity in a sitting position, using a cushion for example.

In addition, the doctor will prescribe anti-inflammatory drugs to ease the pain and physiotherapy to establish proprioception, muscle strength, joint range and dynamic postural balance of the sprain.

Osteopathic Treatment

Other

Each patient will be treated as a whole and within a time limit of 45 minutes. The consultation will start with a medical history followed by medical tests. Then, the osteopath will perform osteopathic tests and manual treatment.

Primary outcomes

  1. Ankle mobility

    Time frame: Week 3

    measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain : a Randomized Controlled Trial

Acronym: OASED

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2021
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.