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

Primary Purpose

Acute Ankle Distortion

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

fascia therapy or transcutaneous fibrolysis

About this trial

This is an interventional treatment trial for Acute Ankle Distortion focused on measuring fascia therapy, transcutaneous fibrolysis, acute ankle distortion

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

acute ankle sprain

Exclusion Criteria:

none

Sites / Locations

University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

fascia therapy

transcutaneous fibrolysis

placebo

Arm Description

arm where fascia therapy is used as a treatment for an acute ankle distortion

arm where transcutaneous fibrolysis is used as a treatment for an acute ankle distortion

arm where placebo therapy is used as a treatment for an acute ankle distortion

Outcomes

Primary Outcome Measures

effect of fascia therapy

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

Self-assessed complaints registration.

Full Information

NCT ID

NCT01249573

First Posted

October 20, 2010

Last Updated

June 9, 2011

Sponsor

University Ghent

1. Study Identification

Unique Protocol Identification Number

NCT01249573

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ankle Distortion

Keywords

fascia therapy, transcutaneous fibrolysis, acute ankle distortion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fascia therapy

Arm Type

Experimental

Arm Description

arm where fascia therapy is used as a treatment for an acute ankle distortion

Arm Title

transcutaneous fibrolysis

Arm Type

Experimental

Arm Description

arm where transcutaneous fibrolysis is used as a treatment for an acute ankle distortion

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

arm where placebo therapy is used as a treatment for an acute ankle distortion

Intervention Type

Other

Intervention Name(s)

fascia therapy or transcutaneous fibrolysis

Intervention Description

fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion

Primary Outcome Measure Information:

Title

effect of fascia therapy

Description

The effect of fascia therapy on an acute ankle distortion. Measurement of muscle power, muscle saturation, joint position sense, tenderness and disability questionnaires.

Time Frame

baseline measurements and within 1 hour after treatment

Secondary Outcome Measure Information:

Title

complaints registration

Description

Self-assessed complaints registration.

Time Frame

baseline, 1 hour after treatment and 3 days later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: acute ankle sprain Exclusion Criteria: none

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Roosen, Prof, PhD

Organizational Affiliation

University Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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