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Thickness of the Plantar Fascia in Stretched and Relaxed Positions in Patients With Plantar Fasciopathy

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ClinicalTrials.gov Identifier: NCT03291665
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Henrik Riel, Aalborg University

Brief Summary:
This study will compare the thickness of the plantar fascia in stretched and relaxed positions in patients with plantar fasciopathy using ultrasonography.

Condition or disease
Plantar Fasciopathy

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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparing Thickness of the Plantar Fascia in Stretched and Relaxed Positions and the Association With Pressure Pain Threshold in Patients With Plantar Fasciopathy
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : April 24, 2018



Primary Outcome Measures :
  1. Thickness of the plantar fascia in sagittal plane [ Time Frame: Immediately after eligibility has been confirmed ]
    The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a sagittal transducer position.


Secondary Outcome Measures :
  1. Pressure pain threshold [ Time Frame: Immediately after eligibility has been confirmed ]
    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.

  2. Thickness of the plantar fascia in transversal plane [ Time Frame: Immediately after eligibility has been confirmed ]
    The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a transversal transducer position



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include patients from the local community of the municipality of Aalborg, Denmark.
Criteria

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

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): NCT03291665


Locations
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Denmark
Research Unit for General Practice
Aalborg, Denmark, 9220
Sponsors and Collaborators
Aalborg University
Investigators
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Study Director: Henrik Riel, M.Sc. Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University

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Responsible Party: Henrik Riel, PhD student, Aalborg University
ClinicalTrials.gov Identifier: NCT03291665     History of Changes
Other Study ID Numbers: 59700
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Henrik Riel, Aalborg University:
Plantar Fasciitis
Plantar heel pain