Clinical trial NCT03291665: Thickness of the Plantar Fascia in Stretched and Relaxed Positions in Patients With Plantar Fasciopathy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plantar Fasciopathy
Keywords: Plantar Fasciitis
Plantar heel pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients from the local community of the municipality of Aalborg, Denmark.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thickness of the plantar fascia in sagittal plane
timeFrame: Immediately after eligibility has been confirmed
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Immediately after eligibility has been confirmed
measure: Thickness of the plantar fascia in transversal plane
timeFrame: Immediately after eligibility has been confirmed
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Unit for General Practice
Study officials:
affiliation: Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
name: Henrik Riel, M.Sc.
role: STUDY_DIRECTOR
References:
citation: Ostermann S, Olesen JL, Holden S, Riel H. Stretching and relaxing the plantar fascia may change plantar fascia thickness but not pressure pain thresholds: a cross-sectional study of patients with plantar fasciopathy. BMC Musculoskelet Disord. 2020 Dec 3;21(1):804. doi: 10.1186/s12891-020-03833-x.