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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Pain intensity during movement (Visual Analogue Scale, 0-10)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and
- •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.
排除标准
- •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.
研究组 & 干预措施
Low resistance exercise without blood flow restriction
Eight sessions of exercise during 4 weeks, 30% repetition maximum, without blood occlusion
干预措施: Resistance exercise without BFR (Procedure)
Low resistance exercise with blood occlusion
Eight sessions of exercise during 4 weeks, 30% repetition maximum, and 50% blood occlusion
干预措施: Resistance exercise with BFR (Device)
结局指标
主要结局
Pain intensity during movement (Visual Analogue Scale, 0-10)
时间窗: Baseline, 2 weeks, and 4 weeks.
Pain intensity perceived on a Visual Analogue Scale during movement (flexion and abduction movement without load), being 0 no pain and 10 the worst pain imaginable.
次要结局
- Pain intensity at rest (Visual Analogue Scale, 0-10)(Baseline, 2 weeks, and 4 weeks.)
- Pressure pain threshold(Before the session, immediately after, and 1 hour post-intervention)
- Kinesiophobia(Baseline, 2 weeks, and 4 weeks.)
- Occurrence of adverse effects(Immediately after the intervention, 1 hour, 6 hours, 24 hours.)
- Pain Catastrophizing(Baseline, 2 weeks, and 4 weeks.)
- Pain and Disability(Baseline, 2 weeks, and 4 weeks.)
- Shoulder Disability(Baseline, 2 weeks, and 4 weeks.)
- Muscle Strength(Baseline, 2 weeks, and 4 weeks.)
- Pressure pain threshold(Before the session, immediately after, and 1 hour post-intervention)
- Occurrence of adverse effects(Immediately after the intervention, 1 hour, 6 hours, 24 hours.)
- Pain intensity at rest (Visual Analogue Scale, 0-10)(Baseline, 2 weeks, and 4 weeks.)
- Kinesiophobia(Baseline, 2 weeks, and 4 weeks.)
- Pain Catastrophizing(Baseline, 2 weeks, and 4 weeks.)
- Pain and Disability(Baseline, 2 weeks, and 4 weeks.)
- Muscle Strength(Baseline, 2 weeks, and 4 weeks.)
- Satisfaction with methodology(4 weeks.)
- Shoulder Disability(Baseline, 2 weeks, and 4 weeks.)
研究者
Adrián Escriche Escuder
Assistant professor
University of Valencia