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

Primary Purpose

Ankle Sprains

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Medical treatment
osteopathic treatment
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Reims

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osteopathic treatment / Usual care

Usual care

Arm Description

osteopathic treatment will be applied in this intervention group.

Classic medical treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2021
Last Updated
September 1, 2022
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT04999254
Brief Title
Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain
Acronym
OASED
Official Title
Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 28, 2021 (Actual)
Primary Completion Date
April 10, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants will be assigned to one of two or more groups in parallel for the duration pot the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic treatment / Usual care
Arm Type
Experimental
Arm Description
osteopathic treatment will be applied in this intervention group.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Classic medical treatment
Intervention Type
Other
Intervention Name(s)
Medical treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
osteopathic treatment
Intervention Description
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 Outcome Measure Information:
Title
Ankle mobility
Description
measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one
Time Frame
Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain

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