Assessing Intratendinous Pressure and Its Correlation With Tendon Structure, Patient Characteristics, and Pain Symptoms in Individuals With and Without Midportion Achilles Tendinopathy
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Lotte De Wilde
- Telefonnummer: +329 332 12 60
- E-post: Lotte.DeWilde@UGent.be
Studieorter
-
-
-
Ghent, Belgien, 9000
- Department of rehabilitation sciences
-
Kontakt:
- Lotte De Wilde
- Telefonnummer: +329 332 12 60
- E-post: Lotte.DeWilde@UGent.be
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Healthy controls
Individuals without achilles tendinopathy |
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 |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intratendinous pressure
Tidsram: Single measurement at baseline
|
Intratendinous pressure in the achilles tendon (mm Hg) |
Single measurement at baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient reported outcome measures
Tidsram: 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
Tidsram: 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
Tidsram: Recorded at baseline
|
Collection of demographic and clinical variables including: age in years |
Recorded at baseline
|
|
Patient characteristics
Tidsram: Recorded at baseline
|
Collection of demographic and clinical variables including: sex (M/V/X) |
Recorded at baseline
|
|
Patient characteristics
Tidsram: Recorded at baseline
|
Collection of demographic and clinical variables including: height in cm |
Recorded at baseline
|
|
Patient characteristics
Tidsram: Recorded at baseline
|
Collection of demographic and clinical variables including: weight in kg |
Recorded at baseline
|
|
Patient characteristics
Tidsram: 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
Tidsram: Recorded at baseline
|
Collection of demographic and clinical variables including: profession |
Recorded at baseline
|
|
Patient characteristics
Tidsram: Recorded at baseline
|
Collection of demographic and clinical variables including: physical activity level (using a 6-point likert scale) |
Recorded at baseline
|
|
Patient characteristics
Tidsram: Recorded at baseline
|
Collection of demographic and clinical variables including: duration of symptoms in weeks |
Recorded at baseline
|
|
Tendon structure
Tidsram: Single measurement at baseline
|
Assessment of tendon characteristics using ultrasound including: tendon thickness (anteroposterior diameter in cm) |
Single measurement at baseline
|
|
Tendon structure
Tidsram: Single measurement at baseline
|
Assessment of tendon characteristics using ultrasound including: cross-sectional area (cm²) |
Single measurement at baseline
|
|
Tendon structure
Tidsram: Single measurement at baseline
|
Assessment of tendon characteristics using ultrasound including: vascularity (color and power doppler signal) |
Single measurement at baseline
|
|
Tendon structure
Tidsram: 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
Tidsram: Single measurement at baseline
|
Assessment of tendon characteristics using MRI including: tendon volume (cm²) |
Single measurement at baseline
|
|
Tendon structure
Tidsram: Single measurement at baseline
|
Assessment of tendon characteristics using MRI including: T2/T2* mapping |
Single measurement at baseline
|
|
Perfusion pressure
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ONZ-2025-0357
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .