Plantar Fasciitis, ChronicNCT07878273
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
An observational study of Plantar Fasciitis, Chronic and Tibial Nerve, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to examine the relationship between tibial nerve cross-sectional area at the tarsal tunnel and plantar fascia thickness, pressure pain threshold, foot posture, and functional status in individuals with chronic plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis, Chronic, Tibial Nerve
- What is being tested?
- Pressure Pain Threshold Assessment, Plantar fascia ultrasonographic Assessment and Tibial nerve ultrasonographic assessment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals applying to the Physical Medicine and Rehabilitation Clinic of Sultan 2. Abdülhamid Han Training and Research Hospital will be evaluated, and those who meet the inclusion criteria for the groups and sign the voluntary consent form will be included in the study.
Who may be able to join
- Be between the ages of 18-65
- Have heel pain that has been ongoing for at least 6 months, especially noticeable during the first few steps after getting up in the morning
- Have tenderness upon palpation of the medial calcaneal tubercle
- Have read and signed the volunteer consent form (VCF)
- Being completely healthy
- Being between 18 - 65 years old
- Having read and signed the Volunteer Consent Form (BGOF)
Who cannot join
- Being under 18 or over 65 years old
- Having a history of physical therapy, injection, radiation, or surgery targeting the plantar fascia or tibial nerve within the last 6 months
- Calcaneus fracture, tumour, or cyst related to the plantar fascia
- Lumbosacral radiculopathy, polyneuropathy
- Rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, gout
- Foot and ankle osteoarthritis
Show all 13Show fewer
- Presence of osteomyelitis or skin infection in the foot
- Systemic diseases such as kidney and liver failure, diabetes, peripheral arterial vascular disease
- Pregnancy
- Healty-control-group
- Being under 18 or over 65 years old
- Having any acute or chronic disease
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi
Istanbul
Feyza Nur Yücel, Assoc.Prof., (0216) 542 20 00, dr.fny28@gmail.com
About this study
Official title: Relationship of Tibial Nerve Cross-Sectional Area in the Tarsal Tunnel to Plantar Fascia Thickness, Pressure Pain Threshold, Foot Posture, and Functional Status in Individuals With Chronic Plantar Fasciitis
This cross-sectional observational study aims to examine the relationship between tibial nerve cross-sectional area at the tarsal tunnel and plantar fascia thickness, pressure pain threshold, foot posture, and functional status in individuals with chronic plantar fasciitis. Ultrasound measurements and clinical assessments will be used to explore whether tibial nerve morphology is associated with structural, pain-related, and functional findings. The findings may improve understanding of chronic plantar fasciitis and inform future prospective research.
Read the detailed description
In patients with plantar fasciitis, pain and functional loss are mostly associated with plantar fascia pathology. However, in some patients, the severity of pain and functional impairment may not be fully explained by the thickness of the plantar fascia. This situation suggests that foot posture, pain sensitivity, and possible tibial nerve involvement may contribute to the clinical picture, especially in chronic plantar fasciitis.
The evaluation of the relationship between the cross-sectional area of the tibial nerve and clinical and functional findings in patients with chronic plantar fasciitis may contribute to a more comprehensive understanding of plantar fasciitis. With this study, it will be investigated whether the evaluation of not only the thickness of the plantar fascia but also the morphology of the tibial nerve at the tarsal tunnel level is clinically significant in plantar fasciitis. Due to the observational, cross-sectional nature of our study, it is not possible to establish a cause-and-effect relationship; however, determining the relationship between the cross-sectional area of the tibial nerve and the thickness of the plantar fascia and pain will provide data that could serve as a basis for examining the cause-and-effect relationship prospectively in the future. The results obtained may contribute to identifying focal points in the treatment of plantar fasciitis.
- Conditions
- Plantar Fasciitis, Chronic, Tibial Nerve
- Being tested
- Pressure Pain Threshold Assessment, Plantar fascia ultrasonographic Assessment, Tibial nerve ultrasonographic assessment
- Keywords
- plantar fasciitis, tibial nerve, foot posture
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Pain Threshold AssessmentOther
Also called PPT
Pressure pain threshold measurements will be performed using a pressure algometer to assess pain sensitivity.
Plantar fascia ultrasonographic AssessmentOther
Also called US
Ultrasonographic evaluation will be performed to measure plantar fascia thickness
Tibial nerve ultrasonographic assessmentOther
Also called US
Ultrasonographic evaluation will be performed to assess tibial nerve cross sectional area in tarsal tunnel.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Plantar Fasciitis Group | Patients with plantar fasciitis Receives: Other: Pressure Pain Threshold Assessment; Other: Plantar fascia ultrasonographic Assessment; Other: Tibial nerve ultrasonographic assessment | |
| Healthy Volunteers (control group) | Healthy Volunteers Receives: Other: Pressure Pain Threshold Assessment; Other: Plantar fascia ultrasonographic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of tibial nerve cross-sectional area with ultrasonographic evaluation
The tibial nerve image will be obtained from within the tarsal tunnel and will be visualised by holding it with a prop at minimum pressure next to the medial malleolus, under the flexor retinaculum, alongside the artery-venous bundle. Three measurements will be taken for the nerve cross-sectional area, and the mean will be calculated. An independent researcher will code and record all obtained images, and the images will be analysed using the ImageJ offline DICOM software 1.8 ® (National Institute of Health, Bethesda, MD, USA, v.1.53a).
Measured: baseline
Secondary outcomes (6)
Pressure Pain Threshold - calcaneus
Pressure pain threshold is defined as the minimal pressure level that causes pain. The measurement will be applied twice with a 1-minute interval, and the average of these applications will be recorded. A trial test will be conducted on the patient before the actual test. Pressure will be applied with a pressure algometer until pain is induced, and the test will be terminated when the patient feels pain.
The measurement will be taken from the calcaneus bone (the attachment point of the plantar fascia) using a Wagner manual pressure algometer (1 cm² probe-10 kg/20 lb).
Measured: Baseline
Numeric Pain Rating Scale, NPRS
Pain severity will be evaluated using a scale rated from 0 (no pain) to 10 (unbearable pain). Participants will be asked to rate the pain felt with the first step after waking up in the morning and the average pain level over the past week.
Measured: baseline
Foot Posture Index
The participant's foot will be observationally scored based on six anatomical criteria in a standing natural posture, and the total score will be recorded.
Measured: baseline
Short Form-12 (SF-12)
Physical Component Summary and Mental Component Summary
Measured: Baseline
Foot Function Index
The Foot Function Index is a self-report-based scale developed to evaluate the effects of foot and ankle-related problems on pain, functional limitation, and daily life activities in individuals, with its validity and reliability demonstrated. FFI consists of three sub-dimensions: pain, disability (functional limitation), and activity limitation. The scale allows individuals to evaluate foot-related problems they have experienced recently in the context of daily life activities. Each sub-dimension and total score reflect the level of impairment in foot functions. Increasing FFI scores indicate that the severity of foot pain and the limitations in foot functions have increased, thereby negatively affecting foot-related quality of life. FFI is widely used in clinical and research settings to evaluate the functional effects of foot pathologies.
Measured: baseline
Thickness of the plantar fascia in ultrasonographic imaging
In the study, the evaluation with ultrasound will be conducted while the participants are in a prone position on the examination table, with their feet hanging off the table and in a dorsiflexed position. A linear probe will be placed longitudinally over the medial tubercle of the calcaneus to ultrasonographically examine the plantar fascia thickness (PFT). PFT will be measured 1 cm distal to the calcaneus attachment point. A PFT of 4 mm or greater will be considered evidence of fasciitis. It has been shown that this measurement technique has good intra-rater reliability. The Sonosite M-Turbo device will be used for ultrasonography and will be performed by a physical therapy and rehabilitation specialist with 10 years of experience.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start7 Sep 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Plantar Fasciitis, ChronicStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Feyza Nur Yücel, Assoc. Prof., Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878273
- Sponsor's protocol ID
- 26
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.
PubMed 17400020Labib SA, Gould JS, Rodriguez-del-Rio FA, Lyman S. Heel pain triad (HPT): the combination of plantar fasciitis, posterior tibial tendon dysfunction and tarsal tunnel syndrome. Foot Ankle Int. 2002 Mar;23(3):212-20. doi: 10.1177/107110070202300305.
PubMed 11934063Chang CW, Wang YC, Hou WH, Lee XX, Chang KF. Medial calcaneal neuropathy is associated with plantar fasciitis. Clin Neurophysiol. 2007 Jan;118(1):119-23. doi: 10.1016/j.clinph.2006.09.028. Epub 2006 Nov 13.
PubMed 17095287Sabir N, Demirlenk S, Yagci B, Karabulut N, Cubukcu S. Clinical utility of sonography in diagnosing plantar fasciitis. J Ultrasound Med. 2005 Aug;24(8):1041-8. doi: 10.7863/jum.2005.24.8.1041.
PubMed 16040817Xiong S, Goonetilleke RS, Jiang Z. Pressure thresholds of the human foot: measurement reliability and effects of stimulus characteristics. Ergonomics. 2011 Mar;54(3):282-93. doi: 10.1080/00140139.2011.552736.
PubMed 21390958
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Tibial Nerve Cross-Sectional Area in the Tarsal Tunnel to Plantar Fascia Thickness, Pressure Pain Threshold, Foot Posture, and Functional Status in Individuals With Chronic Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07878273
- Acronym / sponsor ID
- 26
- Conditions
- Plantar Fasciitis, Chronic, Tibial Nerve
- Keywords
- plantar fasciitis, tibial nerve, foot posture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (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 cross-sectional observational study aims to examine the relationship between tibial nerve cross-sectional area at the tarsal tunnel and plantar fascia thickness, pressure pain threshold, foot posture, and functional status in individuals with chronic plantar fasciitis. Ultrasound measurements and clinical assessments will be used to explore whether tibial nerve morphology is associated with structural, pain-related, and functional findings. The findings may improve understanding of chronic plantar fasciitis and inform future prospective research.
Detailed description
In patients with plantar fasciitis, pain and functional loss are mostly associated with plantar fascia pathology. However, in some patients, the severity of pain and functional impairment may not be fully explained by the thickness of the plantar fascia. This situation suggests that foot posture, pain sensitivity, and possible tibial nerve involvement may contribute to the clinical picture, especially in chronic plantar fasciitis.
The evaluation of the relationship between the cross-sectional area of the tibial nerve and clinical and functional findings in patients with chronic plantar fasciitis may contribute to a more comprehensive understanding of plantar fasciitis. With this study, it will be investigated whether the evaluation of not only the thickness of the plantar fascia but also the morphology of the tibial nerve at the tarsal tunnel level is clinically significant in plantar fasciitis. Due to the observational, cross-sectional nature of our study, it is not possible to establish a cause-and-effect relationship; however, determining the relationship between the cross-sectional area of the tibial nerve and the thickness of the plantar fascia and pain will provide data that could serve as a basis for examining the cause-and-effect relationship prospectively in the future. The results obtained may contribute to identifying focal points in the treatment of plantar fasciitis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Plantar Fasciitis Group | – | Other: Pressure Pain Threshold Assessment, Other: Plantar fascia ultrasonographic Assessment, Other: Tibial nerve ultrasonographic assessmentPatients with plantar fasciitis |
| Healthy Volunteers (control group) | – | Other: Pressure Pain Threshold Assessment, Other: Plantar fascia ultrasonographic AssessmentHealthy Volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals applying to the Physical Medicine and Rehabilitation Clinic of Sultan 2. Abdülhamid Han Training and Research Hospital will be evaluated, and those who meet the inclusion criteria for the groups and sign the voluntary consent form will be included in the study.
Key inclusion criteria (7 listed)
- Being completely healthy
- Being between 18 - 65 years old
- Having read and signed the Volunteer Consent Form (BGOF)
Key exclusion criteria (13 listed)
- Healty-control-group
- Being under 18 or over 65 years old
- Having any acute or chronic disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure Pain Threshold AssessmentAlso: PPTPressure pain threshold measurements will be performed using a pressure algometer to assess pain sensitivity. | Other | Chronic Plantar Fasciitis Group, Healthy Volunteers (control group) |
| Plantar fascia ultrasonographic AssessmentAlso: USUltrasonographic evaluation will be performed to measure plantar fascia thickness | Other | Chronic Plantar Fasciitis Group, Healthy Volunteers (control group) |
| Tibial nerve ultrasonographic assessmentAlso: USUltrasonographic evaluation will be performed to assess tibial nerve cross sectional area in tarsal tunnel. | Other | Chronic Plantar Fasciitis Group |
Primary outcome
Assessment of tibial nerve cross-sectional area with ultrasonographic evaluation
Time frame: baseline
The tibial nerve image will be obtained from within the tarsal tunnel and will be visualised by holding it with a prop at minimum pressure next to the medial malleolus, under the flexor retinaculum, alongside the artery-venous bundle. Three measurements will be taken for the nerve cross-sectional area, and the mean will be calculated. An independent researcher will code and record all obtained images, and the images will be analysed using the ImageJ offline DICOM software 1.8 ® (National Institute of Health, Bethesda, MD, USA, v.1.53a).
6 secondary outcomes
Pressure Pain Threshold - calcaneus
Time frame: Baseline
Numeric Pain Rating Scale, NPRS
Time frame: baseline
Foot Posture Index
Time frame: baseline
Short Form-12 (SF-12)
Time frame: Baseline
Foot Function Index
Time frame: baseline
Thickness of the plantar fascia in ultrasonographic imaging
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 17400020Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.
- Background: PubMed 11934063Labib SA, Gould JS, Rodriguez-del-Rio FA, Lyman S. Heel pain triad (HPT): the combination of plantar fasciitis, posterior tibial tendon dysfunction and tarsal tunnel syndrome. Foot Ankle Int. 2002 Mar;23(3):212-20. doi: 10.1177/107110070202300305.
- Background: PubMed 17095287Chang CW, Wang YC, Hou WH, Lee XX, Chang KF. Medial calcaneal neuropathy is associated with plantar fasciitis. Clin Neurophysiol. 2007 Jan;118(1):119-23. doi: 10.1016/j.clinph.2006.09.028. Epub 2006 Nov 13.
- Background: PubMed 16040817Sabir N, Demirlenk S, Yagci B, Karabulut N, Cubukcu S. Clinical utility of sonography in diagnosing plantar fasciitis. J Ultrasound Med. 2005 Aug;24(8):1041-8. doi: 10.7863/jum.2005.24.8.1041.
- Background: PubMed 21390958Xiong S, Goonetilleke RS, Jiang Z. Pressure thresholds of the human foot: measurement reliability and effects of stimulus characteristics. Ergonomics. 2011 Mar;54(3):282-93. doi: 10.1080/00140139.2011.552736.
- 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.
Feyza Nur Yücel, Assoc. Prof. study director
Saglik Bilimleri Universitesi
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 Fasciitis, Chronic and Tibial Nerve, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feyza Nur Yücel, Assoc. Prof. (2165422000 ext. +90, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of tibial nerve cross-sectional area with ultrasonographic evaluation (time frame: baseline). 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 NCT07878273, which also lists 5 linked publications.
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 16 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.