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

June 9, 2011 updated by: University Ghent

The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain in Young Adults.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute ankle sprain

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline measurements and within 1 hour after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complaints registration
Time Frame: baseline, 1 hour after treatment and 3 days later
Self-assessed complaints registration.
baseline, 1 hour after treatment and 3 days later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Philip Roosen, Prof, PhD, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

November 25, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2010/580

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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