Differences in Exercise-induced Hypoalgesia After a Session With Different Blood Flow Restriction Protocols in People With Rotator Cuff-related Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain intensity at rest (Visual Analogue Scale, 0-10)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 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
排除标准
- •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
研究组 & 干预措施
Resistance exercise with low blood occlusion
A single session of exercise, 30% repetition maximum, and 30% blood occlusion
干预措施: Resistance exercise with low AOP (Device)
Resistance exercise with moderate blood occlusion
A single session of exercise, 30% repetition maximum, and 50% blood occlusion
干预措施: Resistance exercise with moderate BFR (Device)
Resistance exercise with high blood occlusion
A single session of exercise, 30% repetition maximum, and 70% blood occlusion
干预措施: Resistance exercise with high BFR (Device)
Resistance exercise with sham blood flow restriction
A single session of exercise, 30% repetition maximum, and without blood restriction (cuff applied without pressure)
干预措施: Resistance exercise with sham BFR (Device)
结局指标
主要结局
Pain intensity at rest (Visual Analogue Scale, 0-10)
时间窗: Periprocedural
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
Pain intensity during movement (Visual Analogue Scale, 0-10)
时间窗: Periprocedural
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
- Pressure pain threshold(Periprocedural)
- Exercise tolerance with each setting(Periprocedural)
- Occurrence of adverse effects(Immediately after the intervention, 1 hour, 6 hours, 24 hours)
- Surface electromyography(Periprocedural)
研究者
Adrián Escriche Escuder
PhD
University of Valencia