Меню
Идёт набор NCT03456778

Assessing the Tendons With Shear Wave Elastography

— Наблюдательное Tendinopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Shear Wave Elastography.
Кому может быть актуально
Состояния в реестре: Tendinopathy. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Assessing the Efficacy of the Treatment of Tendinopathy With Shear Wave Elastography

Обзор

The purpose of this study is to utilize Shear Wave Elastography (SWE) to study the viscoelastic properties of tendons to understand the functional differences between normal/asymptomatic and symptomatic tendon states. The study will also assess the degree of tendon healing following standard of care treatment.

Подробное описание

Tendinopathy is a common affliction in athletes, recreational exercisers, the general population and even inactive people. Tendon pathology presenting clinically is most commonly seen in the chronic state related to tendon degeneration manifested as intra-tendinous mucoid degeneration and chondroid metaplasia, which in many cases is accompanied by superimposed small intrasubstance/interstitial tears. Then a vicious cycle of attempted inadequate healing with superimposed acute pathology ensues leading to significant pain and discomfort over time significantly limiting physical activity. The exact pathogenesis of this disease has not been clarified scientifically.

The first part of this study aims to establish the difference between asymptomatic and symptomatic tendons among patients affected by moderate-to-severe, chronic (\>6 months of symptoms) tendinopathy in comparison to asymptomatic patients. After establishing a range of elastography normal to severe pathologic measurements, a second part of the study will focus on utilizing ultrasound elastography imaging follow up to assess degree of tendon healing after various standard of care treatments.

The purpose of this prospective observational study is to utilize a ultrasound modality known as real-time Shear Wave Elastography (SWE) to study the viscoelastic properties of tendons, such as the Achilles, patellar, quadriceps, epicondylar, and rotator cuff, to understand the functional differences between normal/asymptomatic (n=75) vs symptomatic (n=75) tendon states (total n=150). The secondary aim will be to assess the degree of tendon healing after standard of care treatment. The clinical implications are very significant because it will provide insights into the mechanism of tendon healing.

Вмешательства

  • Устройство Shear Wave Elastography
    An ultrasound (US) technique, known as shear wave elastography (SWE), is used to examine structure and biomechanical function. The examination takes place in the ultrasound room at the study site and lasts for approximately 20 minutes.

Первичные конечные точки

  • Viscoelastic Tendon Property [Срок оценки: Baseline]
  • Change in Tendon Healing [Срок оценки: Baseline, Month 3, Month 6, Month 12]
  • Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score [Срок оценки: Month 6, Month 9, Month 12]
  • Change in Victorian Institute of Sport Assessment - Patellar Tendon (VISA-P) Score [Срок оценки: Month 6, Month 9, Month 12]
  • Change in The Foot & Ankle Disability Index (FADI) Score [Срок оценки: Month 6, Month 9, Month 12]
  • Change in The Foot & Ankle Disability Index (FADI) Sport Score [Срок оценки: Month 6, Month 9, Month 12]

Критерии участия

Inclusion Criteria for Asymptomatic Volunteers:

  • Patients presenting at the study location with lower extremity pain without tendon involvement

Inclusion Criteria for Symptomatic Volunteers:

  • Patients presenting at the study location with a clinical diagnosis of tenalgia
  • Diagnosis of tendinopathy confirmed by ultrasound

Критерии исключения

  • Pregnancy
  • History of tendinopathy or surgery and morphologic abnormalities
  • History of systemic, metabolic, endocrine diseases, or psoriasis
  • History of treatment with corticosteroids, estrogens, long term quinolone antibiotics, and cholesterol drugs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • Emory Orthopaedics and Spine Center — Atlanta

Идентификаторы

NCT: NCT03456778 · IRB00096405

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗