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

May 16, 2018 updated by: Henrik Riel, Aalborg University

Comparing Thickness of the Plantar Fascia in Stretched and Relaxed Positions and the Association With Pressure Pain Threshold in Patients With Plantar Fasciopathy

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

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalborg, Denmark, 9220
        • Research unit for general practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include patients from the local community of the municipality of Aalborg, Denmark.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after eligibility has been confirmed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after eligibility has been confirmed
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
Immediately after eligibility has been confirmed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Henrik Riel, M.Sc., Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2017

Primary Completion (Actual)

April 24, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 59700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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