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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01249573
Other study ID # EC/2010/580
Secondary ID
Status Completed
Phase N/A
First received October 20, 2010
Last updated June 9, 2011
Start date October 2010
Est. completion date May 2011

Study information

Verified date June 2011
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- acute ankle sprain

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline measurements and within 1 hour after treatment No
Secondary complaints registration Self-assessed complaints registration. baseline, 1 hour after treatment and 3 days later No