Меню
Набор скоро начнётся NCT07497737

OMT for Adhesive Capsulitis

Фаза IV С лечением Adhesive Capsulitis of the Shoulder Frozen Shoulder

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: Intra-articular Injection, Osteopathic Manipulative Therapy (OMT).
Кому может быть актуально
Состояния в реестре: Adhesive Capsulitis of the Shoulder, Frozen Shoulder. Базовые параметры: 18 лет — 89 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

Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis

Обзор

The goal of this clinical trial is to learn if Osteopathic Manipulative Treatment (OMT) is an effective addition to treatment of adhesive capsulitis. OMT is a non-invasive treatment in which a doctor gently moves and stretches muscles, joints, and tissues manually. Adhesive capsulitis is more commonly known as "frozen shoulder" and describes a shoulder that becomes stiff, painful, and limited in its motion due to some structural change in the joint. The main questions it aims to answer are: Is recovery faster when OMT is added to regular treatment? Are patients that underwent OMT more satisfied with their treatment? Researchers will compare patients who underwent OMT to patients who did not to see if OMT is an effective additional treatment for frozen shoulder. Participants will: * Be assigned to one of the four experimental groups * Visit clinic and/or physical therapy to undergo the treatments associated with their group: 1. standard course of prescribed physical therapy 2. standard course of prescribed physical therapy and an injection of an anti-inflammatory and anesthetics in the shoulder 3. standard course of prescribed physical therapy and (up to) 4 OMT sessions 4. standard course of prescribed physical therapy, an injection of an anti-inflammatory and anesthetics in the shoulder, and (up to) 4 OMT sessions. * Visit clinic 1 month, 3 months, 6 months, and 1 year after treatment is complete * Complete a survey about how satisfied they are with their treatment 1 month, 3 months, 6 months, and 1 year after it is complete

Вмешательства

  • Препарат Intra-articular Injection
    Intra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%)
  • Другое Osteopathic Manipulative Therapy (OMT)
    Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues

Первичные конечные точки

  • Time to Recovery as Measured in Months [Срок оценки: Up to 12 months]
Вторичные конечные точки (3)
  • Change in Range of Motion of the Shoulder Relative to Baseline [Срок оценки: Baseline (before treatment) and then 1 month, 3 months, 6 months, and 12 months after treatment has ended]
  • Change in Patient Satisfaction as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM) [Срок оценки: Measured 1 month, 3 months, 6 months, and 12 months after the end of treatment.]
  • Change in Pain as Measured by Patient-Reported Pain Score [Срок оценки: Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.]

Критерии участия

Критерии включения

  • patients diagnosed with adhesive capsulitis who have not received prior treatment for it

Критерии исключения

  • patients with contraindications to corticosteroid injections (uncontrolled diabetes, active infection, bleeding disorders, or corticosteroid hypersensitivity)
  • patients diagnosed with adhesive capsulitis who have received (or are currently receiving) treatment for it

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • UH Ahuja Medical Center — Beachwood
  • UH St. John Health Center — Westlake
  • UH Westlake Health Center — Westlake

Публикации

  • Veera S, Chin J, Kleyn L, Spinelli S, Tafler L. Use of Osteopathic Manipulation for Treatment of Chronic Shoulder Injury Related to Vaccine Administration. Cureus. 2020 Jul 12;12(7):e9156. doi: 10.7759/cureus.9156. PMID 32789092
  • Vita F, Pederiva D, Tedeschi R, Spinnato P, Origlio F, Faldini C, Miceli M, Stella SM, Galletti S, Cavallo M, Pilla F, Donati D. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound. 2024 Sep;27(3):579-587. doi: 10.1007/s40477-024-00891-y. Epub 2024 Jun 6. PMID 38844748
  • Allen GM. The diagnosis and management of shoulder pain. J Ultrason. 2018;18(74):234-239. doi: 10.15557/JoU.2018.0034. PMID 30451406

Идентификаторы

NCT: NCT07497737 · STUDY20260072

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗