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The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249573
First Posted: November 30, 2010
Last Update Posted: June 10, 2011
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.
Information provided by:
University Ghent
  Purpose
This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis in the treatment of an acute ankle sprain. These treatments will be compared to a placebo group.

Condition Intervention
Acute Ankle Distortion Other: fascia therapy or transcutaneous fibrolysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain in Young Adults.

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • effect of fascia therapy [ Time Frame: baseline measurements and within 1 hour after treatment ]
    The effect of fascia therapy on an acute ankle distortion. Measurement of muscle power, muscle saturation, joint position sense, tenderness and disability questionnaires.


Secondary Outcome Measures:
  • complaints registration [ Time Frame: baseline, 1 hour after treatment and 3 days later ]
    Self-assessed complaints registration.


Estimated Enrollment: 60
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fascia therapy
arm where fascia therapy is used as a treatment for an acute ankle distortion
Other: fascia therapy or transcutaneous fibrolysis
fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion
Experimental: transcutaneous fibrolysis
arm where transcutaneous fibrolysis is used as a treatment for an acute ankle distortion
Other: fascia therapy or transcutaneous fibrolysis
fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion
Placebo Comparator: placebo
arm where placebo therapy is used as a treatment for an acute ankle distortion
Other: fascia therapy or transcutaneous fibrolysis
fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion

Detailed Description:

Ankle sprain is the most occurring sport related injury. In spite of the high prevalence of this injury and the often residual symptoms, there is a large variety in diagnostic approach and therapeutic protocols. Concerning the treatment of an acute ankle sprain, it remains a challenge to minimize injury consequences on short and long term.

In this study we investigate the immediate effect of two therapeutic techniques: fascia therapy and transcutaneous fibrolysis. They will be compared to a third group, who receives a placebo treatment. Muscle strength, muscle vascularisation, muscle tenderness and joint position sense are measured before and after treatment.

The purpose of this study is to contribute to the knowledge of treating acute ankle sprains.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute ankle sprain

Exclusion Criteria:

  Contacts and Locations
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): NCT01249573


Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Philip Roosen, Prof , PhD University Ghent
  More Information

Responsible Party: Prof. Dr. Philip Roosen, University Ghent
ClinicalTrials.gov Identifier: NCT01249573     History of Changes
Other Study ID Numbers: EC/2010/580
First Submitted: October 20, 2010
First Posted: November 30, 2010
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by University Ghent:
fascia therapy
transcutaneous fibrolysis
acute ankle distortion

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries