Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain (OASED)

February 18, 2026 updated by: CHU de Reims

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Osteopathic treatment / Usual care
osteopathic treatment will be applied in this intervention group.
Other: Medical treatment

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.

Other: osteopathic treatment
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.
Active Comparator: Usual care
Classic medical treatment
Other: Medical treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle mobility
Time Frame: Week 3
measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one
Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2021

Primary Completion (Actual)

April 10, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO21093*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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