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Relationship Between Central Sensitization and Clinical Features in Plantar Fasciitis

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

128

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Feyza Nur Yücel, Assoc. Prof.
  • Numero di telefono: +90 2165422000
  • Email: dr.fny28@gmail.com

Luoghi di studio

      • Istanbul, Turchia (Türkiye)
        • Reclutamento
        • Sultan Abdulhamid Han Training and Research Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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)
  2. 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)
  2. 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Plantar fasciitis group
Participants with clinically diagnosed plantar fasciitis.
Pressure pain threshold measurements will be performed using a pressure algometer to assess pain sensitivity.
Ultrasonographic evaluation will be performed to measure plantar fascia thickness and assess plantar fascia morphology.
Healthy Volunteers (control group)
Age- and sex-matched healthy adults without plantar fasciitis.
Pressure pain threshold measurements will be performed using a pressure algometer to assess pain sensitivity.
Ultrasonographic evaluation will be performed to measure plantar fascia thickness and assess plantar fascia morphology.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Forearm Pressure Pain Threshold (PPT)
Lasso di tempo: Baseline

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numeric Pain Rating Scale, NPRS
Lasso di tempo: Baseline
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.
Baseline
Short Form-12 (SF-12)
Lasso di tempo: Baseline
Physical Component Summary and Mental Component Summary
Baseline
Foot Function Index
Lasso di tempo: Baseline
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.
Baseline
Pain Catastrophizing Scale
Lasso di tempo: Baseline
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.
Baseline
Tampa Scale for Kinesiophobia
Lasso di tempo: Baseline
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.
Baseline
Central Sensitization Inventory
Lasso di tempo: Baseline
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.).
Baseline
Thickness of the plantar fascia in ultrasonographic imaging
Lasso di tempo: Baseline
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.
Baseline
Hospital Anxiety and Depression Scale
Lasso di tempo: CROSS-SECTIONAL
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.
CROSS-SECTIONAL
Weight-Bearing Lunge Test
Lasso di tempo: Baseline
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.
Baseline
FOOT POSTURE INDEX
Lasso di tempo: Baseline
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.
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Feyza Nur Yücel, Saglik Bilimleri Universitesi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 aprile 2026

Completamento primario (Stimato)

20 settembre 2026

Completamento dello studio (Stimato)

20 settembre 2026

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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