<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03291665</url>
  </required_header>
  <id_info>
    <org_study_id>59700</org_study_id>
    <nct_id>NCT03291665</nct_id>
  </id_info>
  <brief_title>Thickness of the Plantar Fascia in Stretched and Relaxed Positions in Patients With Plantar Fasciopathy</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the thickness of the plantar fascia in stretched and relaxed&#xD;
      positions in patients with plantar fasciopathy using ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this observational study is to compare the thickness of the plantar fascia in&#xD;
      stretched and relaxed positions of the most symptomatic heel in patients with plantar&#xD;
      fasciopathy using ultrasonography.&#xD;
&#xD;
      In addition to this, we will compare measurements of the thickness of the plantar fascia in&#xD;
      sagittal versus transversal transducer positions, compare pressure pain thresholds at the&#xD;
      most tender spot of the plantar fascia in stretched and relaxed position using pressure&#xD;
      algometry and investigate the association between the thickness of the plantar fascia and the&#xD;
      pressure pain threshold. All measurements are performed bilaterally starting with the most&#xD;
      symptomatic foot.&#xD;
&#xD;
      To compare thickness and pressure pain thresholds in stretched and relaxed positions of the&#xD;
      plantar fascia paired-t-tests are used. To compare the most and least symptomatic sides&#xD;
      paired-t-tests will be used.&#xD;
&#xD;
      The association between the thickness of the plantar fascia and pressure pain threshold will&#xD;
      be investigated using the Pearson's correlation coefficient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">April 24, 2018</completion_date>
  <primary_completion_date type="Actual">April 24, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Thickness of the plantar fascia in sagittal plane</measure>
    <time_frame>Immediately after eligibility has been confirmed</time_frame>
    <description>The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a sagittal transducer position.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pressure pain threshold</measure>
    <time_frame>Immediately after eligibility has been confirmed</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thickness of the plantar fascia in transversal plane</measure>
    <time_frame>Immediately after eligibility has been confirmed</time_frame>
    <description>The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a transversal transducer position</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Plantar Fasciopathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include patients from the local community of the municipality of Aalborg,&#xD;
        Denmark.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of plantar heel pain of at least 3 months&#xD;
&#xD;
          -  Clinical presentation of pain and/or tenderness to palpation in the area of the medial&#xD;
             tubercle of the calcaneus&#xD;
&#xD;
          -  Average intensity of pain in the previous week equal to or greater than 3 on an&#xD;
             11-point visual analog scale (VAS)&#xD;
&#xD;
          -  Thickness of symptomatic plantar fascia of 4 mm or greater&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of systemic disease with manifestations similar to those of plantar&#xD;
             fasciopathy&#xD;
&#xD;
          -  Pain medication in the last 24 hours&#xD;
&#xD;
          -  Steroid injection for plantar fasciopathy in the previous 6 months&#xD;
&#xD;
          -  Previous heel surgery or fracture of the lower leg or foot&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henrik Riel, M.Sc.</last_name>
    <role>Study Director</role>
    <affiliation>Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Unit for General Practice</name>
      <address>
        <city>Aalborg</city>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Henrik Riel</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <keyword>Plantar Fasciitis</keyword>
  <keyword>Plantar heel pain</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03291665
org study id: 59700
nct id: NCT03291665
lead sponsor: 
has dmc: No
This study will compare the thickness of the plantar fascia in stretched and relaxed
      positions in patients with plantar fasciopathy using ultrasonography.
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Thickness of the plantar fascia in sagittal plane
time frame: Immediately after eligibility has been confirmed
description: The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a sagittal transducer position.
measure: Pressure pain threshold
time frame: Immediately after eligibility has been confirmed
description: 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.
measure: Thickness of the plantar fascia in transversal plane
time frame: Immediately after eligibility has been confirmed
description: The thickness will be measured in mm in stretched and relaxed positions using ultrasonography with a transversal transducer position
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henrik Riel, M.Sc.
role: Study Director
affiliation: Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Henrik Riel
investigator title: PhD student
sharing ipd: Undecided