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Plantar FasciitisNCT07640620

Relationship Between Central Sensitization and Clinical Features in Plantar Fasciitis

An observational study of Plantar Fasciitis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Plantar fasciitis is a common cause of heel pain and is traditionally considered a mechanical musculoskeletal disorder. Recent evidence suggests that central sensitization may also contribute to pain in individuals with 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
What is being tested?
Pressure Pain Threshold Assessment and Ultrasonographic Assessment
How many people
128 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Apr 2026to 20 Sep 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 Outpatient 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.

Plantar Fasciitis Group

  1. Inclusion criteria
  • Be between the ages of 18-65
  • Have unilateral heel pain that has been ongoing for at least 3 months, particularly worsening with the first few steps in the morning and increasing with weight-bearing activities throughout the day
  • Have tenderness on palpation of the medial calcaneal tubercle
  • Have read and signed the volunteer consent form (VCF)
  1. Exclusion criteria
  • Being under 18 years old or over 65 years old
  • Having a history of physical therapy, injection, radiation, or surgery targeting the plantar fascia within the last 6 months
  • Calcaneus fracture, tumor, or cyst related to the plantar fascia
  • Foot deformity (club foot, pes cavus, calcaneovalgus, etc.)
  • Lumbosacral radiculopathy, tarsal tunnel syndrome, peripheral neuropathy
  • Rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, gout
  • Foot and ankle osteoarthritis
  • Presence of osteomyelitis or skin infection in the foot
  • Systemic diseases such as kidney and liver failure, diabetes, peripheral arterial vascular disease

Healthy Control

  1. Inclusion criteria
  • Being completely healthy
  • Being between the ages of 18 - 65
  • Having read and signed the volunteer consent form (BGOF)
  1. Exclusion criteria
  • Being under 18 or over 65 years old
  • Having any acute or chronic illness
  • Being illiterate and not giving consent to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Feyza Nur Yücel, Assoc. Prof. contact

2165422000 ext. +90

dr.fny28@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Sultan Abdulhamid Han Training and Research Hospital

    Istanbul

    Feyza Nur Yücel, 0216 542 20 00, dr.fny28@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: IInvestigation of the Relationship Between Central Sensitization and Clinical, Functional, and Ultrasonographic Parameters In Plantar Fasciitis

Plantar fasciitis is a common cause of heel pain and is traditionally considered a mechanical musculoskeletal disorder. Recent evidence suggests that central sensitization may also contribute to pain in individuals with plantar fasciitis. This study aims to investigate the relationships between neurophysiological variables (pressure pain threshold, central sensitization, and pain intensity), psychological factors (pain catastrophizing, kinesiophobia, anxiety, and depression), ultrasonographic findings (plantar fascia thickness), and functional outcomes (foot function and quality of life) in patients with plantar fasciitis.

Read the detailed description

Heel pain caused by plantar fasciitis is one of the common reasons for visits to Physical Medicine and Rehabilitation outpatient clinics. Plantar fasciitis is characterized by throbbing medial plantar heel pain that occurs especially with the first step in the morning or after long periods of rest and is a musculoskeletal disorder. The diagnosis of plantar fasciitis is usually determined clinically. In ultrasound, findings such as thickening of the plantar fascia and hypoechogenicity in the fascia are advantageous in diagnosis. Although the mechanical aspect of pain has often been emphasized in the treatment of plantar fasciitis, recent studies have gained momentum in suggesting that central sensitization is also among the pain mechanisms of plantar fasciitis. In addition, as with many chronic musculoskeletal pains, the role of psychological factors such as kinesiophobia, catastrophizing pain, depressive symptoms, and anxiety has been investigated in plantar fasciitis. However, data on the relationship between factors such as pressure pain sensitivity, central sensitization, catastrophizing pain, and kinesiophobia in plantar fasciitis are limited. The aim of this study is to contribute to the increasing literature in this field by investigating the relationship between psychological (catastrophizing pain, kinesiophobia, anxiety, and depression), ultrasonographic findings (plantar fascia thickness), and functional status (foot functional index, quality of life) variables with neurophysiological (pressure pain threshold, central sensitization, pain) variables in plantar fasciitis.

Being tested
Pressure Pain Threshold Assessment, Ultrasonographic Assessment
Keywords
plantar fasciitis, central sensitization, pain pressure threshold, kinesiophobia
Medical subject headings
Fasciitis, Plantar, Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressure Pain Threshold AssessmentOther

    Pressure pain threshold measurements will be performed using a pressure algometer to assess pain sensitivity.

  • Ultrasonographic AssessmentOther

    Ultrasonographic evaluation will be performed to measure plantar fascia thickness and assess plantar fascia morphology.

Study groups in NCT07640620
Study groupRoleWhat they receive
Plantar fasciitis groupParticipants with clinically diagnosed plantar fasciitis.
Receives: Other: Pressure Pain Threshold Assessment; Other: Ultrasonographic Assessment
Healthy Volunteers (control group)Age- and sex-matched healthy adults without plantar fasciitis.
Receives: Other: Pressure Pain Threshold Assessment; Other: Ultrasonographic Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forearm Pressure Pain Threshold (PPT)

    Pressure pain threshold is defined as the minimal pressure level that causes pain. The measurement will be applied twice for each region 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 to selected points with a pressure algometer until pain is induced, and the test for that area will be terminated when the patient feels pain.

    The measurement will be taken from the calcaneus bone (the starting point of the plantar fascia) and from the forearm, which is a distant, painless, and unrelated area, using the Wagner manual pressure algometer (1 cm² probe-10 kg/20 lb). The reliability of the measurement in these areas has been demonstrated.

    Measured: Baseline

Secondary outcomes (10)
  1. 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

  2. Short Form-12 (SF-12)

    Physical Component Summary and Mental Component Summary

    Measured: Baseline

  3. 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. AFI 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 AFI scores indicate that the severity of foot pain and the limitations in foot functions have increased, thereby negatively affecting foot-related quality of life. AFI is widely used in clinical and research settings to evaluate the functional effects of foot pathologies.

    Measured: Baseline

  4. Pain Catastrophizing Scale

    It is a valid and reliable self-report scale developed to assess individuals' exaggerated negative thoughts and emotional responses toward their pain experience. The scale measures cognitive and emotional responses that occur during or following pain and consists of three sub-dimensions: rumination (excessive focus on pain), magnification (exaggeration of the threatening consequences of pain), and helplessness.

    Measured: Baseline

  5. Tampa Scale for Kinesiophobia

    It is a valid and reliable self-report scale developed to assess individuals' fear and avoidance behaviors toward movement and physical activity. The scale measures the level of fear of movement (kinesiophobia) that develops based on the belief that pain will reoccur or worsen.

    Measured: Baseline

  6. Central Sensitization Inventory

    The central sensitization scale is a tool used to assess the hypersensitivity of the central nervous system. This scale includes questions that examine individuals' pain perception and its effects on daily life to detect the effects of central sensitization, which are generally observed in chronic pain conditions. The scale evaluates how individuals perceive pain in response to physical contact or other stimuli (pain sensitivity), changes in their sensitivity to heat, cold, or pressure (sensory changes), how the persistence of pain affects their daily activities, and the impact of pain on their emotional state (anxiety, depression, etc.).

    Measured: Baseline

  7. 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). PFK will be measured 1 cm distal to the calcaneus attachment point. A PFK 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

  8. Hospital Anxiety and Depression Scale

    It is a 14-item self-report scale that quickly, reliably, and independently of medical conditions assesses patients' anxiety and depression symptoms over the past week.

    Measured: CROSS-SECTIONAL

  9. Weight-Bearing Lunge Test

    The range of motion of ankle dorsiflexion will be evaluated under load. The participant will be asked to keep their heel in contact with the ground and move their knee toward the wall, and the maximum distance between the thumb and the wall will be recorded in centimeters.

    Measured: Baseline

  10. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study start7 Apr 2026
  3. Primary completion20 Sep 2026 (estimated)
  4. Study completion20 Sep 2026 (estimated)

Resources

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
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640620
Sponsor's protocol ID
E-54230385-929-301089224
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data collected during this study will not be made available to other researchers.

Publications

  • Jayaseelan DJ, Fernandez-de-Las-Penas C, Blattenberger T, Bonneau D. Altered Central Pain Processing in Patients With Chronic Plantar Heel Pain: A Critically Appraised Topic. J Sport Rehabil. 2021 Feb 16;30(5):812-817. doi: 10.1123/jsr.2020-0371.

    PubMed 33596547
  • Nijs J, Malfliet A, Nishigami T. Nociplastic pain and central sensitization in patients with chronic pain conditions: a terminology update for clinicians. Braz J Phys Ther. 2023 May-Jun;27(3):100518. doi: 10.1016/j.bjpt.2023.100518. Epub 2023 Jun 14. No abstract available.

    PubMed 37348359
  • Plaza-Manzano G, Rios-Leon M, Martin-Casas P, Arendt-Nielsen L, Fernandez-de-Las-Penas C, Ortega-Santiago R. Widespread Pressure Pain Hypersensitivity in Musculoskeletal and Nerve Trunk Areas as a Sign of Altered Nociceptive Processing in Unilateral Plantar Heel Pain. J Pain. 2019 Jan;20(1):60-67. doi: 10.1016/j.jpain.2018.08.001. Epub 2018 Aug 16.

    PubMed 30121357
  • Cotchett M, Lennecke A, Medica VG, Whittaker GA, Bonanno DR. The association between pain catastrophising and kinesiophobia with pain and function in people with plantar heel pain. Foot (Edinb). 2017 Aug;32:8-14. doi: 10.1016/j.foot.2017.03.003. Epub 2017 Mar 20.

    PubMed 28605621
  • Bennell KL, Talbot RC, Wajswelner H, Techovanich W, Kelly DH, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44(3):175-180. doi: 10.1016/s0004-9514(14)60377-9.

    PubMed 11676731
  • Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.

    PubMed 16182419
  • Sabir 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 16040817

Questions about this trial

What is this clinical trial studying?

An observational study of Plantar Fasciitis, 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?

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 11 Jun 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?

Forearm Pressure Pain Threshold (PPT) (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 NCT07640620, which also lists 7 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 11 Jun 2026.

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