Ankle SprainsOASEDNCT04999254
Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain
A study testing Medical treatment and osteopathic treatment in people with Ankle Sprains, run by CHU de Reims at 1 site in France.
Trial 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... Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Medical treatment and osteopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Understanding French
- Agreeing to participate in the study and having signed the consent form
- Apyretic
- Patient affiliated to a social security schem
Who cannot join
- 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
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- Person deprived of liberty by a judicial or administrative decision
- Neoplasia
- Any contraindication to osteopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain : a Randomized Controlled Trial
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...
Read more
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
- Being tested
- Medical treatment, osteopathic treatment
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical treatmentOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic treatment / Usual care | Experimental | osteopathic treatment will be applied in this intervention group. Receives: Other: Medical treatment; Other: osteopathic treatment |
| Usual care | Active comparator | Classic medical treatment Receives: Other: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle mobility
measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start28 Nov 2021
- Primary completion10 Apr 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999254
- Sponsor's protocol ID
- PO21093*
- Acronym
- OASED
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bournon C, Prin-Conti D, Douay J, Montfajon PA, Kanagaratnam L, Gennai S. Early osteopathic treatment delivered to patients with an acute lateral ankle sprain improves recovery: an investigative study. J Osteopath Med. 2026 Jan 22. doi: 10.1515/jom-2025-0096. Online ahead of print.
PubMed 41568624
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04999254
- Acronym / sponsor ID
- OASED / PO21093*
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants will be assigned to one of two or more groups in parallel for the duration pot the study
| Arm | Type | Receives |
|---|---|---|
| Osteopathic treatment / Usual care | Experimental | Other: Medical treatment, Other: osteopathic treatmentosteopathic treatment will be applied in this intervention group. |
| Usual care | Active comparator | Other: Medical treatmentClassic medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- Fractured foot, tibia, fibula
- Stage 3 ankle sprain
- Operated sprain
- Current use of drugs/alcohol
- Altered mental state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical treatmentMedical 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 / Usual care, Usual care |
| osteopathic treatmentEach 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. | Other | Osteopathic treatment / Usual care |
Primary outcome
Ankle mobility
Time frame: Week 3
measure ankle dorsiflexion range of motion - the injured ankle should have identical mobility to the healthy one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 41568624Bournon C, Prin-Conti D, Douay J, Montfajon PA, Kanagaratnam L, Gennai S. Early osteopathic treatment delivered to patients with an acute lateral ankle sprain improves recovery: an investigative study. J Osteopath Med. 2026 Jan 22. doi: 10.1515/jom-2025-0096. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical treatment and osteopathic treatment in people with Ankle Sprains, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle mobility (time frame: Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.