Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain

Not Applicable

Completed

• Conditions: Ankle Sprains
• Interventions: Other: Medical treatment; Other: osteopathic treatment

• Registration Number: NCT04999254
• Lead Sponsor: CHU de Reims

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-10
• Study Start: 2021-11-28
• Primary Completion: 2022-04-10
• Status Verified: 2022-09
• Study Completion: 2022-09-01
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Medical treatment	Classic medical treatment
Osteopathic treatment / Usual care	Medical treatment	osteopathic treatment will be applied in this intervention group.
Osteopathic treatment / Usual care	osteopathic treatment	osteopathic treatment will be applied in this intervention group.

Primary Outcome Measures

Name	Time	Method
Ankle mobility	Week 3	measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France