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

Sponsor

CHU de Reims (Other)

Overall Status

Recruiting

CT.gov ID

NCT04999254

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Sprains	Other: Medical treatment Other: osteopathic treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

participants will be assigned to one of two or more groups in parallel for the duration pot the studyparticipants will be assigned to one of two or more groups in parallel for the duration pot the study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 28, 2021

Anticipated Primary Completion Date :

Oct 27, 2022

Anticipated Study Completion Date :

Nov 27, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Ankle mobility [Week 3]
measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Reims	Reims		France	51092

Sponsors and Collaborators

CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHU de Reims

ClinicalTrials.gov Identifier:

NCT04999254

Other Study ID Numbers:

PO21093*

First Posted:

Aug 10, 2021

Last Update Posted:

Dec 14, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Sprains and Strains

Ankle Injuries

Study Results

No Results Posted as of Dec 14, 2021