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
About this trial
This is an interventional treatment trial for Ankle Sprains
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
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
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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