Plantar FasciopathyNCT03291665
Thickness of the Plantar Fascia in Stretched and Relaxed Positions in Patients With Plantar Fasciopathy
An observational study of Plantar Fasciopathy, run by Aalborg University at 1 site in Denmark.
Trial summary
This study will compare the thickness of the plantar fascia in stretched and relaxed positions in patients with plantar fasciopathy using ultrasonography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciopathy
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Sep 2017to 24 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients from the local community of the municipality of Aalborg, Denmark.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will compare the thickness of the plantar fascia in stretched and relaxed positions in patients with plantar fasciopathy using ultrasonography.
Read the 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.
- Conditions
- Plantar Fasciopathy
- Keywords
- Plantar Fasciitis, Plantar heel pain
- Medical subject headings
- Fasciitis, Plantar
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after eligibility has been confirmed
Secondary outcomes (2)
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.
Measured: Immediately after eligibility has been confirmed
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
Measured: Immediately after eligibility has been confirmed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start29 Sep 2017
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Riel, Aalborg University
- Investigators
- Henrik Riel, M.Sc., Study director, Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291665
- Sponsor's protocol ID
- 59700
- Status last verified
- May 2018
- First submitted
- 18 Sep 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33272236
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03291665
- Acronym / sponsor ID
- 59700
- Conditions
- Plantar Fasciopathy
- Keywords
- Plantar Fasciitis, Plantar heel pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients from the local community of the municipality of Aalborg, Denmark.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Pressure pain threshold
Time frame: Immediately after eligibility has been confirmed
Thickness of the plantar fascia in transversal plane
Time frame: Immediately after eligibility has been confirmed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 33272236Ostermann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Riel, M.Sc. study director
Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Fasciopathy, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the plantar fascia in sagittal plane (time frame: Immediately after eligibility has been confirmed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.