The Sprained AnkleNCT00284765
Management of the Sprained Ankle by Help of NSAID-Plaster
A study testing flector in people with The Sprained Ankle, run by Kolding Sygehus at 1 site in Denmark.
Trial summary
The purpose of this trial is to study the management of the sprained ankle by help of NSAID-plaster. A questionnaire. The effect of RICE and RICE + NSAID-plaster in the treatment of the sprained ankle, compared by pain-score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Sprained Ankle
- What is being tested?
- flector
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to May 2006
- 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
- A sprained ankle, less than 24 hours old, understanding Danish, 18 years or older
Who cannot join
- Fracture of the ankle, wound around the ankle, allergy of NSAID- pregnancy, daily use of NSAID, GI-bleeding
Trial locations and contacts
1 site in 1 country.
Berit Jørgensen contact
Denmark1 site, 1 recruiting
- Recruiting
Kolding Sygehus
Kolding
Berit Jørgensen, MD, bekajo@fks.vejleamt.dk
Berit Jørgensen, MD
About this study
Official title: Optimation of Treatment of the Sprained Ankle by Help of NSAID-Plaster (Flector). A Questionnaire.
The purpose of this trial is to study the management of the sprained ankle by help of NSAID-plaster. A questionnaire. The effect of RICE and RICE + NSAID-plaster in the treatment of the sprained ankle, compared by pain-score.
- Conditions
- The Sprained Ankle
- Being tested
- flector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flectorProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Sprained AnkleStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Investigators
- Berit Jørgensen, MD, Principal investigator, Kolding Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284765
- Sponsor's protocol ID
- VF-20050182
- Status last verified
- Jan 2006
- First submitted
- 31 Jan 2006
- Last updated
- 13 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimation of Treatment of the Sprained Ankle by Help of NSAID-Plaster (Flector). A Questionnaire.
- ClinicalTrials.gov ID
- NCT00284765
- Acronym / sponsor ID
- VF-20050182
- Conditions
- The Sprained Ankle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- May 2006
- First posted
- 1 Feb 2006 (estimated)
- 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 purpose of this trial is to study the management of the sprained ankle by help of NSAID-plaster. A questionnaire. The effect of RICE and RICE + NSAID-plaster in the treatment of the sprained ankle, compared by pain-score.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A sprained ankle, less than 24 hours old, understanding Danish, 18 years or older
Key exclusion criteria (1 listed)
- Fracture of the ankle, wound around the ankle, allergy of NSAID- pregnancy, daily use of NSAID, GI-bleeding
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 |
|---|---|---|
| flector | Procedure or surgery | – |
Primary outcome
Pain-score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2006.
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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.
Berit Jørgensen contact
Berit Jørgensen, MD principal investigator
Kolding Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flector in people with The Sprained Ankle, run by Kolding Sygehus at 1 site in Denmark.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2006. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berit Jørgensen (bekajo@fks.vejleamt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2006.