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Management of the Sprained Ankle by Help of NSAID-Plaster

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00284765
Recruitment Status : Unknown
Verified January 2006 by Kolding Sygehus.
Recruitment status was:  Recruiting
First Posted : February 1, 2006
Last Update Posted : March 13, 2006
Information provided by:
Kolding Sygehus

Brief 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.

Condition or disease Intervention/treatment
The Sprained Ankle Procedure: flector

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Optimation of Treatment of the Sprained Ankle by Help of NSAID-Plaster (Flector). A Questionnaire.
Study Start Date : February 2006
Estimated Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Pain-score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A sprained ankle, less than 24 hours old, understanding Danish, 18 years or older

Exclusion Criteria:

  • Fracture of the ankle, wound around the ankle, allergy of NSAID- pregnancy, daily use of NSAID, GI-bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284765

Contact: Berit Jørgensen bekajo@fks.vejleamt.dk

Kolding Sygehus Recruiting
Kolding, Denmark
Contact: Berit Jørgensen, MD       bekajo@fks.vejleamt.dk   
Principal Investigator: Berit Jørgensen, MD         
Sponsors and Collaborators
Kolding Sygehus
Principal Investigator: Berit Jørgensen, MD Kolding Sygehus

ClinicalTrials.gov Identifier: NCT00284765     History of Changes
Other Study ID Numbers: VF-20050182
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: March 13, 2006
Last Verified: January 2006

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries
Diclofenac hydroxyethylpyrrolidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action