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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

2026. november 2. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

60

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Belgium
      • Ghent, Belgium, 9000
        • Department of rehabilitation sciences
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: CASE_CONTROL
  • Időperspektívák: CROSS_SECTIONAL

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
Healthy controls

Individuals without achilles tendinopathy
Diagnosztikai vizsgálat: 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
Diagnosztikai vizsgálat: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Intratendinous pressure
Időkeret: Single measurement at baseline

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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Patient reported outcome measures
Időkeret: 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
Időkeret: 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
Időkeret: Recorded at baseline

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

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

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

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

Collection of demographic and clinical variables including: profession
Recorded at baseline
Patient characteristics
Időkeret: Recorded at baseline

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

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

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

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

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

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

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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University Hospital, Ghent

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. október 28.

Elsődleges befejezés (Becsült)

2026. december 1.

A tanulmány befejezése (Becsült)

2026. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2025. november 14.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 2.

Első közzététel (Tényleges)

2026. november 9.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 9.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 2.

Utolsó ellenőrzés

2026. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

  • ONZ-2025-0357

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

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Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

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Nem

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