NCT03291665

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

September 18, 2017

Last Update Submit

May 16, 2018

Conditions

Keywords

Plantar FasciitisPlantar heel pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pressure pain threshold

    Immediately after eligibility has been confirmed

  • Thickness of the plantar fascia in transversal plane

    Immediately after eligibility has been confirmed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice

Aalborg, 9220, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Henrik Riel, M.Sc.

    Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 25, 2017

Study Start

September 29, 2017

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations