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Completed

NCT Number: NCT03291665

Thickness of the Plantar Fascia in Stretched and Relaxed Positions 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Unit for General Practice

Aalborg, 9220, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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