Effects of a 4-week Low-intensity Training With Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

Официальное название

Analysis of the Effects of a 4-week Low-intensity Training With and Without Blood Flow Restriction in People With Rotator Cuff-related Shoulder Pain

Обзор

This study aims to analyze the effects of 4 weeks of low-intensity exercise with and without blood flow restriction (BFR) on pain, fear of movement, catastrophizing about pain, strength, and disability in a population with rotator cuff-related shoulder pain. There are two modalities corresponding to the same exercises under different blood flow restriction conditions: 1) 3 low-intensity exercises (30% 1RM) with BFR (50% AOP); 2) 3 low-intensity exercises (30% 1RM) without BFR. Participants will be randomly assigned to one of two groups and will undergo a 4-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.

Вмешательства

• Устройство Resistance exercise with 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.
• Процедура Resistance exercise without 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 without flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.

Первичные конечные точки

• Pain intensity during movement (Visual Analogue Scale, 0-10) [Срок оценки: Baseline, 2 weeks, and 4 weeks.]

Вторичные конечные точки (9)

• Pain intensity at rest (Visual Analogue Scale, 0-10) [Срок оценки: Baseline, 2 weeks, and 4 weeks.]
• Pressure pain threshold [Срок оценки: Before the session, immediately after, and 1 hour post-intervention]
• Kinesiophobia [Срок оценки: Baseline, 2 weeks, and 4 weeks.]
• Occurrence of adverse effects [Срок оценки: Immediately after the intervention, 1 hour, 6 hours, 24 hours.]
• Pain Catastrophizing [Срок оценки: Baseline, 2 weeks, and 4 weeks.]
• Pain and Disability [Срок оценки: Baseline, 2 weeks, and 4 weeks.]
• Shoulder Disability [Срок оценки: Baseline, 2 weeks, and 4 weeks.]
• Muscle Strength [Срок оценки: Baseline, 2 weeks, and 4 weeks.]
• Satisfaction with methodology [Срок оценки: 4 weeks.]

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

• Pain of an intensity that prevents performance of 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 drop arm test).
• Suspected frozen shoulder (50% reduction or more than 30° loss of 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 injection within the last 6 weeks.
• Presence of diseases such as inflammatory arthritis, neurological diseases, fibromyalgia, malignant tumors, or polymyalgia rheumatica.
• Presence of comorbidities that increase cardiovascular risk, such as hypertension, diabetes, or heart failure.
• Presence of more than one thromboembolism risk factor (obesity, history of thrombosis, prolonged immobilization, recent surgery, use of contraceptives, etc.).
• Presence of active skin lesions in the area where the sleeve will be placed, recent scars or burns, or chronic dermatological diseases that compromise skin integrity,
• 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

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07324993 · 2025-FIS-3960959

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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