NCT07640620

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress71%
Apr 2026Sep 2026

Study Start

First participant enrolled

April 7, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 1, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

plantar fasciitiscentral sensitizationpain pressure thresholdkinesiophobia

Outcome Measures

Primary Outcomes (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.

    Baseline

Secondary Outcomes (10)

  • Numeric Pain Rating Scale, NPRS

    Baseline

  • Short Form-12 (SF-12)

    Baseline

  • Foot Function Index

    Baseline

  • Pain Catastrophizing Scale

    Baseline

  • Tampa Scale for Kinesiophobia

    Baseline

  • +5 more secondary outcomes

Study Arms (2)

Plantar fasciitis group

Participants with clinically diagnosed plantar fasciitis.

Other: Pressure Pain Threshold AssessmentOther: Ultrasonographic Assessment

Healthy Volunteers (control group)

Age- and sex-matched healthy adults without plantar fasciitis.

Other: Pressure Pain Threshold AssessmentOther: Ultrasonographic Assessment

Interventions

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

Healthy Volunteers (control group)Plantar fasciitis group

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

Healthy Volunteers (control group)Plantar fasciitis group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Being completely healthy
  • Being between the ages of 18 - 65
  • Having read and signed the volunteer consent form (BGOF)
  • Being under 18 or over 65 years old
  • Having any acute or chronic illness
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • 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.

    PMID: 33596547BACKGROUND
  • 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.

    PMID: 37348359BACKGROUND
  • 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.

    PMID: 30121357BACKGROUND
  • 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.

    PMID: 28605621BACKGROUND
  • 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.

    PMID: 11676731BACKGROUND
  • 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.

    PMID: 16182419BACKGROUND
  • 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.

    PMID: 16040817BACKGROUND

MeSH Terms

Conditions

Fasciitis, PlantarKinesiophobia

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Feyza Nur Yücel

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Nur Yücel, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 11, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

September 20, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data collected during this study will not be made available to other researchers.

Locations