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Набор скоро начнётся NCT07478718

Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy

Без фазы С лечением Women Following Unilateral Mastectomy

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: Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted.
Кому может быть актуально
Состояния в реестре: Women Following Unilateral Mastectomy. Базовые параметры: 30 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Иордания
Следующий шаг
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Официальное название

Effect of Targeted Scapular and Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy "Randomized Controlled Trial"

Обзор

Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome

Подробное описание

Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome. Conventional physiotherapy provides general postoperative rehabilitation but may not adequately address altered scapulothoracic mechanics or psychological factors that contribute to persistent dysfunction. Targeted scapular and shoulder exercises may enhance clinical recovery; however, high-quality evidence supporting their effectiveness remains limited

Вмешательства

  • Процедура Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted
    Interventions 1\. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration * 3 sessions/week * 45-60 minutes per session * Total duration: 8 weeks (24 sessions) * Conducted by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience (10). Exercise Components The program consists of five progressive phases: Phase 1: Mobility and Motor Control (Week 1-2) * Pendulum exercises * Active-assisted ROM using pulleys or wand * Scapular clocks

Первичные конечные точки

  • Shoulder Function [Срок оценки: 8 weeks]
Вторичные конечные точки (1)
  • Secondary out come [Срок оценки: 16weeks]

Критерии участия

Критерии включения

  • Participants must meet all of the following criteria:
  • Female adults between 30 and 65 years old.
  • History of unilateral breast cancer managed with either:
  • Modified radical mastectomy, or
  • Breast-conserving surgery with axillary clearance.
  • Postoperative interval between 4 and 12 weeks before enrollment.
  • Objective evidence of impaired shoulder mobility or function including:
  • Reduction of ROM ≥ 15% compared to the contralateral side,
  • VAS pain ≥ 3/10 during shoulder movement, or
  • DASH functional score > 25.
  • Ability to ambulate independently and follow therapist instructions.
  • Willingness to commit to the full rehabilitation protocol for 8 weeks.

Критерии исключения

  • Participants will be excluded if they have:
  • Previously diagnosed shoulder disorders (adhesive capsulitis, rotator cuff tear, fracture/dislocation).
  • Active or untreated lymphedema Grade II-III.
  • Ongoing chemotherapy-induced neuropathy causing shoulder dysfunction.
  • History of neurological or rheumatological disorders affecting the upper limb.
  • Metastatic disease or local recurrence.
  • Recent infection, seroma, or unhealed surgical wounds.
  • Participation in another physical therapy or exercise program in the past 4 weeks.
  • Cognitive impairment or psychiatric conditions interfering with adherence.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Иордания · 1 центр
  • Hany elgohary — Jerash

Публикации

  • Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6. PMID 36922413
  • Pirincci CS, Dalyan M, Delialioglu SU, Celenay ST. Effects of scapulothoracic stabilization exercises on scapular function, posture, and balance in lymphedema after mastectomy: a randomized controlled trial. Women Health. 2023 Apr;63(4):251-265. doi: 10.1080/03630242.2023.2178836. Epub 2023 Feb 22. PMID 36814100

Идентификаторы

NCT: NCT07478718 · Badr University in Cairo

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗