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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Denmark
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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