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

Plantar Fasciopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291665
• Other study ID #: 59700
• Status: Completed
• Start date: September 29, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: May 2018
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 24, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plantar Fasciopathy

Locations

Country	Name	City	State
Denmark	Research Unit for General Practice	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thickness of the plantar fascia in sagittal plane	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	Pressure pain threshold	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
Secondary	Thickness of the plantar fascia in transversal plane	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