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Exercise-induced Hypoalgesia Effects of Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

Без фазы С лечением Rotator Cuff Related Shoulder Pain

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: Resistance exercise with low AOP, Resistance exercise with moderate BFR, Resistance exercise with high BFR, Resistance exercise with sham BFR.
Кому может быть актуально
Состояния в реестре: Rotator Cuff Related Shoulder Pain. 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
Испания
Следующий шаг
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Официальное название

Differences in Exercise-induced Hypoalgesia After a Session With Different Blood Flow Restriction Protocols in People With Rotator Cuff-related Shoulder Pain

Обзор

This study aims to compare the effects of blood flow restricted (BFR) exercise and to examine the differences between various BFR protocols on acute pain reduction in individuals with rotator cuff-related shoulder pain, as well as the exercise tolerance at each intensity and occlusion setting. There are four exercise modalities corresponding to different combinations of intensity (%RM) and percentage of occlusion (%AOP): 1) 30% RM and 30% AOP; 2) 30% RM and 50% AOP; 3) 30% RM and 70% AOP; 4) 30% RM and BFR placebo (cuff without pressure). All participants will complete one session of each of the four exercise modalities, analyzing the variables studied in each for subsequent analysis and comparison.

Вмешательства

  • Устройство Resistance exercise with low AOP
    Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 30% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
  • Устройство Resistance exercise with moderate BFR
    Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 50% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
  • Устройство Resistance exercise with high BFR
    Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 70% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
  • Устройство Resistance exercise with sham BFR
    Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a sham blood flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.

Первичные конечные точки

  • Pain intensity at rest (Visual Analogue Scale, 0-10) [Срок оценки: Periprocedural]
  • Pain intensity during movement (Visual Analogue Scale, 0-10) [Срок оценки: Periprocedural]
Вторичные конечные точки (4)
  • Pressure pain threshold [Срок оценки: Periprocedural]
  • Exercise tolerance with each setting [Срок оценки: Periprocedural]
  • Occurrence of adverse effects [Срок оценки: Immediately after the intervention, 1 hour, 6 hours, 24 hours]
  • Surface electromyography [Срок оценки: Periprocedural]

Критерии участия

Критерии включения

  • Age between 18 and 65
  • Shoulder symptoms lasting at least 3 months
  • Pain in the proximal anterolateral aspect of the shoulder, aggravated by abduction
  • At least two of the following tests positive: Jobe test, resisted external rotation test, Hawkins-Kennedy test, Neer test, painful arc between 60 and 120 degrees of shoulder abduction

Критерии исключения

  • History of shoulder trauma or surgery
  • Pain of such intensity that it is impossible to perform the proposed exercises
  • Active arm elevation less than 90 degrees
  • Clinical signs of a complete tear (positive delayed external and internal rotation sign and positive arm drop test)
  • Suspected frozen shoulder (50% reduction or more than 30° loss in passive shoulder external rotation)
  • Primary diagnosis of shoulder instability or acromioclavicular pathology
  • Shoulder pain due to primary involvement in the cervical or thoracic region
  • Corticosteroid injections in the last 6 weeks
  • Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica
  • Presence of more than one risk factor for thromboembolism
  • Participation in upper limb exercise programs in the last month

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Faculty of Physiotherapy, University of Valencia — Valencia

Идентификаторы

NCT: NCT07232511 · 2025-FIS-3945738

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗