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

CHU de Reims

Status: Completed

Conditions: Ankle Sprains

Treatments: Other: Medical treatment; Other: osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04999254

PO21093*

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Osteopathic treatment / Usual care

Experimental group

Description:

osteopathic treatment will be applied in this intervention group.

Treatment:

Other: Medical treatment

Other: osteopathic treatment

Usual care

Active Comparator group

Description:

Classic medical treatment

Treatment:

Other: Medical treatment