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Идёт набор NCT06095050

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Без фазы С лечением Shoulder Pain Tendinopathy Rotator Cuff Tendinitis Rotator Cuff Tendinosis

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: Embolization, Physical Therapy.
Кому может быть актуально
Состояния в реестре: Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis, Rotator Cuff Tendinosis. Базовые параметры: 21 лет — 80 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 →

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Официальное название

Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff

Обзор

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

Подробное описание

This is a single center prospective randomized controlled study at Brigham \& Women's Hospital (BWH), a teaching hospital of Harvard Medical School. Patients with clinical and MRI findings of shoulder tendinopathy, moderate to severe shoulder pain (VAS \> 40), and pain refractory to at least 6 months of physician directed conservative therapy will be eligible for enrollment.At screening patient will undergo a shoulder MRI to evaluate for tendinopathy, and patients with complete full thickness tendon tears will be excluded.

Patients will be randomized to either the TAE +PT or PT group. Patients in the TAE + PT group will undergo angiography to evaluate branch shoulder arteries for hyperemia. If hyperemia is present, then embolization will be performed. This treatment will be followed by 3 months of structured PT. Patients in the PT group will undergo 3-months of structured physical therapy with isolated eccentric exercises.

Вмешательства

  • Устройство Embolization
    Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.
  • Другое Physical Therapy
    Subjects will participate in structured physical therapy consisting of 3 months of eccentric strength training. This twelve-week program will consist of 4 PT sessions at week 0, week 4, week 8, and week 12.

Первичные конечные точки

  • Visual Analog Scale Pain (VAS) Score [Срок оценки: 12 months]
Вторичные конечные точки (4)
  • Adverse Events [Срок оценки: 12 months]
  • Patient-Reported Outcomes Measurement Information System Upper Extremity [Срок оценки: 12 months]
  • Shoulder Pain and Disability Index [Срок оценки: 12 months]
  • MRI Tendinopathy scores [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Male, female, transgender female, transgender male, non-binary
  • Moderate to severe shoulder pain (VAS > 40)
  • Pain refractory to at least 6 months of physician-directed conservative therapy (analgesics or injections or PT), including a minimum of 6 weeks of PT
  • Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy

Критерии исключения

  • History of peripheral arterial disease or peripheral artery disease symptoms including claudication, diminished or absent upper/lower extremity pulses, or known upper extremity arterial atherosclerosis or occlusion that would limit selective angiography
  • Known history of anaphylaxis to iodinated contrast agents or gadolinium based contrast
  • Acute kidney injury
  • Allergy to poppy seeds or lipiodol
  • Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 obtained within 30 days of procedure.
  • Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.8 within 30 days of procedure
  • Active systemic or local upper extremity infection
  • Patient pregnant, intending to become pregnant during the study.
  • Prior shoulder replacement surgery
  • Prior rotator cuff repair surgery
  • Previous history of complete full-thickness tear of the rotator cuff
  • Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06095050 · 2023P002574

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗