Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain

NCT ID: NCT04999254

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-28
• Study Completion Date: 2022-09-01

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.

Conditions

Ankle Sprains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteopathic treatment / Usual care

osteopathic treatment will be applied in this intervention group.

Group Type: EXPERIMENTAL

Medical treatment

Intervention Type: OTHER

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.

osteopathic treatment

Intervention Type: OTHER

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.

Usual care

Classic medical treatment

Group Type: ACTIVE_COMPARATOR

Medical treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Reims

Reims, , France

Countries

France

Other Identifiers

PO21093*

Identifier Type: -

Identifier Source: org_study_id