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Assessing Intratendinous Pressure and Its Correlation With Tendon Structure, Patient Characteristics, and Pain Symptoms in Individuals With and Without Midportion Achilles Tendinopathy

2 novembre 2026 aggiornato da: University Hospital, Ghent

Assessing Intratendinous Pressure and Its Correlation With Tendon Structure, Patient Characteristics, and Pain Symptoms in Individuals With and Without Midportion Achilles Tendinopathy: An Observational Study

Study type: Observational study

Aim: To assess intratendinous pressure in individuals with and without midportion Achilles tendinopathy and investigate its correlation with tendon structure, patient characteristics, and pain symptoms.

Intervention: This is a non-interventional, observational study. Intratendinous pressure is measured using an invasive measurement method (e.g., Compass Universal Hg), used in accordance with its intended purpose.

Participants: Adults aged 18-55, both male and female, including patients with clinically diagnosed Achilles tendinopathy and healthy control participants.

Outcome measures:

  • Primary: Intratendinous pressure (mm Hg)

  • Secondary:

    • Tendon structure (e.g., tendon thickness, cross-sectional area (CSA) (cm2), tendon volume (cm3) determined on ultrasound and MRI)
    • Clinical outcomes (VISA-A, TENDINS-A)
    • Patient characteristics (e.g., activity level, BMI, symptom duration, age,..)

Discussion: The study seeks to better understand whether intratendinous pressure is increased in symptomatic Achilles tendons compared to healthy individuals. It also examines whether there is an association with structural tendon changes, a range of patient-related factors and the clinical symptoms experienced by the patient. The findings may help refine the pathophysiological understanding of Achilles tendinopathy and support the development of future treatment strategies.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Achilles tendinopathy is a debilitating injury that is common among athletes, especially those involved in running sports. Around 30% of all runners exhibit Achilles tendinopathy with an annual incidence of 7-9%. Despite its high prevalence, the underlying pathophysiological mechanisms of Achilles tendinopathy remain incompletely understood. An emerging concept is the potential role of impaired intratendinous pressure homeostasis in the onset and progression of tendinopathy. A substantial body of in vitro and in vivo research concerning intratendinous pressure has already been conducted by Dr. Lauren Pringels, yet important knowledge gaps remain.

This observational study aims to investigate whether intratendinous pressure differs between individuals with and without Achilles tendinopathy. A secondary aim is to explore whether the intratendinous pressure correlates with tendon structure, patient characteristics, and pain symptoms.

Participants will be divided into two groups: patients clinically diagnosed with midportion Achilles tendinopathy, and asymptomatic healthy controls. The study aims to include approximately 25-30 participants per group. Participants will be recruited through sports physicians, physiotherapists, social media and study advertisements. All participants will undergo a standardized evaluation consisting of questionnaires, intratendinous pressure measurement, clinical examination and imaging assessments.

Patient-reported outcome measures will include:

  • VISA-A (Victorian Institute of Sport Assessment - Achilles)
  • TENDINS-A (TENDINopathy Severity Assessment - Achilles)

Patient characteristics such as age, sex, height, weight, BMI, activity level, and symptom duration will be recorded.

Intratendinous pressure measurement will be performed using a simple, directly invasive measurement method (e.g., Compass Universal Hg), in accordance with its intended clinical use. The patient is positioned prone on the examination table, with the foot supported in 30° plantar flexion. In this position, the tension on the tendon is virtually zero, representing the resting condition. The invasive measurement method is introduced under ultrasound guidance and the pressure is determined at the center of the tendon. Needle positioning is done at a 30° angle, in a distal direction and parallel to the collagen fibrils, to minimize tissue trauma.

In patients with Achilles tendinopathy, intratendinous pressure is measured at the point where the tendon is most swollen. In asymptomatic individuals, intratendinous pressure is measured at a fixed point.

Imaging assessments include B-mode ultrasound and MRI scans to assess tendon structure, including tendon thickness, cross-sectional area and tendon volume.

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

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

Contatto studio

Luoghi di studio

  • Belgio
      • Ghent, Belgio, 9000
        • Department of rehabilitation sciences
        • 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

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Participants will be recruited from the outpatient clinics of UZ Gent and on the UGent campus, as well as through local physiotherapy practices and orthopedic clinics in the surrounding region. Recruitment methods include distribution of flyers, social media posts and direct referrals from healthcare providers. The study population consists of adults aged 18-55 years, including individuals with clinically diagnosed midportion Achilles tendinopathy and asymptomatic healthy controls.

Descrizione

Inclusion Criteria healthy controls:

  • Participation in sports that strain the Achilles tendon (recreational or competitive) at least once a week
  • Age: 18-55 y/o

Exclusion Criteria healthy controls:

  • History of Achilles tendinopathy/rupture/surgery or other ankle pathology (e.g., arthritis)
  • Current pain/stiffness in the Achilles tendon (VISA-A < 100)
  • Underlying systemic diseases (rheumatological disorders, e.g., SpA, psoriatic arthritis; hypercholesterolemia; endocrine disorders)
  • Current pregnancy
  • Use of (fluoro)quinolones in the last 2 years
  • Coagulation disorders
  • Contraindication MRI scan

Inclusion Criteria patients with achilles tendinopathy:

  • Participation in sports that strain the Achilles tendon (recreational or competitive) at least once a week
  • Age: 18-55 y/o
  • Duration of symptoms: > 6 weeks and < 3 years
  • Midportion Achilles tendinopathy (a + b + c must be met) (a: Pain from 2.5 cm proximal to the posterosuperior calcaneal edge ; b: Pain during exercise anamnestic/single leg hop test (VAS-HOP) ; c: Ultrasound hypoechoic zones OR power Doppler signal OR increased APD)

Exclusion Criteria patients with achilles tendinopathy:

  • History of Achilles tendon rupture/surgery or other ankle pathology (e.g., arthritis)
  • Combination of midportion + insertional tendinopathy
  • Underlying systemic diseases (rheumatological disorders, e.g., SpA, psoriatic arthritis; hypercholesterolemia; endocrine disorders)
  • Current pregnancy
  • Use of (fluoro)quinolones in the last 2 years ; corticosteroid injection/sclerotherapy/ESWT < 3 months ago
  • Coagulation disorders
  • Contraindication MRI scan

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

  • Modelli osservazionali: CASE_CONTROL
  • Prospettive temporali: CROSS_SECTIONAL

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Healthy controls

Individuals without achilles tendinopathy
Test diagnostico: Intratendinous pressure measurement

Intratendinous pressure measurement will be performed using a simple, directly invasive measurement method (e.g., Compass Universal Hg), in accordance with its intended clinical use. The patient is positioned prone on the examination table, with the foot supported in 30° plantar flexion. In this position, the tension on the tendon is virtually zero, representing the resting condition. The invasive measurement method is introduced under ultrasound guidance and the pressure is determined at the center of the tendon. Needle positioning is done at a 30° angle, in a distal direction and parallel to the collagen fibrils, to minimize tissue trauma.
Patients with achilles tendinopathy

Patients with midportion achilles tendinopathy
Test diagnostico: Intratendinous pressure measurement

Intratendinous pressure measurement will be performed using a simple, directly invasive measurement method (e.g., Compass Universal Hg), in accordance with its intended clinical use. The patient is positioned prone on the examination table, with the foot supported in 30° plantar flexion. In this position, the tension on the tendon is virtually zero, representing the resting condition. The invasive measurement method is introduced under ultrasound guidance and the pressure is determined at the center of the tendon. Needle positioning is done at a 30° angle, in a distal direction and parallel to the collagen fibrils, to minimize tissue trauma.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intratendinous pressure
Lasso di tempo: Single measurement at baseline

Intratendinous pressure in the achilles tendon (mm Hg)
Single measurement at baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient reported outcome measures
Lasso di tempo: Single measurement at baseline

VISA-A (Victorian Institute of Sport Assessment - Achilles) questionnaire ; score from 0-100 (higher score is better with 100 = no dysfunction, no pain)
Single measurement at baseline
Patient reported outcome measures
Lasso di tempo: Single measurement at baseline

TENDINS-A (TENDINopathy Severity Assessment - Achilles) questionnaire ; score ranging from 0-100 (higher score is worse with 0 = no dysfunction, no pain)
Single measurement at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: age in years
Recorded at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: sex (M/V/X)
Recorded at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: height in cm
Recorded at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: weight in kg
Recorded at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: weight and height will be combined to report BMI in kg/m²
Recorded at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: profession
Recorded at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: physical activity level (using a 6-point likert scale)
Recorded at baseline
Patient characteristics
Lasso di tempo: Recorded at baseline

Collection of demographic and clinical variables including: duration of symptoms in weeks
Recorded at baseline
Tendon structure
Lasso di tempo: Single measurement at baseline

Assessment of tendon characteristics using ultrasound including: tendon thickness (anteroposterior diameter in cm)
Single measurement at baseline
Tendon structure
Lasso di tempo: Single measurement at baseline

Assessment of tendon characteristics using ultrasound including: cross-sectional area (cm²)
Single measurement at baseline
Tendon structure
Lasso di tempo: Single measurement at baseline

Assessment of tendon characteristics using ultrasound including: vascularity (color and power doppler signal)
Single measurement at baseline
Tendon structure
Lasso di tempo: Single measurement at baseline

Assessment of tendon characteristics using ultrasound including: tendon thickening (= anteroposterior diameter at thickest part of the tendon (cm) - anteroposterior diameter at 2cm proximal from calcaneal notch (cm))
Single measurement at baseline
Tendon structure
Lasso di tempo: Single measurement at baseline

Assessment of tendon characteristics using MRI including: tendon volume (cm²)
Single measurement at baseline
Tendon structure
Lasso di tempo: Single measurement at baseline

Assessment of tendon characteristics using MRI including: T2/T2* mapping
Single measurement at baseline
Perfusion pressure
Lasso di tempo: Single measurement at baseline

Assessment of blood pressure to calculate perfusion pressure: ((diastolic pressure + 1/3 × [systolic pressure - diastolic pressure]) - intratendinous pressure)
Single measurement at baseline

Collaboratori e investigatori

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

Sponsor

University Hospital, Ghent

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 (Stimato)

28 ottobre 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

14 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

2 novembre 2026

Primo Inserito (Effettivo)

9 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • ONZ-2025-0357

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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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