- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291665
Thickness of the Plantar Fascia in Stretched and Relaxed Positions in Patients With Plantar Fasciopathy
Comparing Thickness of the Plantar Fascia in Stretched and Relaxed Positions and the Association With Pressure Pain Threshold in Patients With Plantar Fasciopathy
Study Overview
Status
Conditions
Detailed Description
The purpose of this observational study is to compare the thickness of the plantar fascia in stretched and relaxed positions of the most symptomatic heel in patients with plantar fasciopathy using ultrasonography.
In addition to this, we will compare measurements of the thickness of the plantar fascia in sagittal versus transversal transducer positions, compare pressure pain thresholds at the most tender spot of the plantar fascia in stretched and relaxed position using pressure algometry and investigate the association between the thickness of the plantar fascia and the pressure pain threshold. All measurements are performed bilaterally starting with the most symptomatic foot.
To compare thickness and pressure pain thresholds in stretched and relaxed positions of the plantar fascia paired-t-tests are used. To compare the most and least symptomatic sides paired-t-tests will be used.
The association between the thickness of the plantar fascia and pressure pain threshold will be investigated using the Pearson's correlation coefficient.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aalborg, Denmark, 9220
- Research unit for general practice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- History of plantar heel pain of at least 3 months
- Clinical presentation of pain and/or tenderness to palpation in the area of the medial tubercle of the calcaneus
- Average intensity of pain in the previous week equal to or greater than 3 on an 11-point visual analog scale (VAS)
- Thickness of symptomatic plantar fascia of 4 mm or greater
Exclusion Criteria:
- Age under 18
- Pregnancy
- History of systemic disease with manifestations similar to those of plantar fasciopathy
- Pain medication in the last 24 hours
- Steroid injection for plantar fasciopathy in the previous 6 months
- Previous heel surgery or fracture of the lower leg or foot
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Thickness of the plantar fascia in sagittal plane
Time Frame: Immediately after eligibility has been confirmed
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The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a sagittal transducer position.
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Immediately after eligibility has been confirmed
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain threshold
Time Frame: Immediately after eligibility has been confirmed
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Measured in kPa at the most tender spot of the plantar fascia in stretched and relaxed position using pressure algometry.
In non-symptomatic feet the antero-medial part of the calcaneus is used as the test site.
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Immediately after eligibility has been confirmed
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Thickness of the plantar fascia in transversal plane
Time Frame: Immediately after eligibility has been confirmed
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The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a transversal transducer position
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Immediately after eligibility has been confirmed
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Henrik Riel, M.Sc., Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 59700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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