Comparing the Effectiveness of Blood Flow Restriction Therapy Versus Standard Exercise After Arthroscopic Rotator Cuff Repair: Protocol for the Multicenter S-TRONGER Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Shoulder muscle strength
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. It is presumed that the addition of BFRT will significantly improve the shoulder strength and muscle mass at the end of the intervention period compared to the group receiving only standard exercises.
Patients who agree to participate in this research will be randomly assigned to a control group (standard exercises alone) or an experimental group (standard rehabilitation with BFRT). The duration of the postoperative intervention will be 12 weeks. The primary variables will be the shoulder muscle strength and muscle mass. Secondary variables will be the active shoulder mobility, pain intensity, upper limb disability, and health-related quality of life. Results will be measured at 0, 4 and 12 weeks postoperative.
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)
盲法说明
Opaque sealed envelopes
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40-65 years
- •Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging
- •Undergoing arthroscopic rotator cuff repair
- •Be able to read and understand Spanish
排除标准
- •Massive irreparable rotator cuff tear
- •Concomitant fracture
- •Labral or nerve injury
- •Suspicious of developing a frozen shoulder
- •Revision surgery after rotator cuff repair
- •Previous corticosteroid injection (< 6 months)
- •Recent surgery (< 1 year) in the contralateral shoulder
- •History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia or clotting disorders
- •Severe or uncontrolled hypertension, or any comorbid condition that impedes participants to complete the intervention
研究组 & 干预措施
Standard exercises with BFRT
Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises with BFRT during the three phases of standard rehabilitation.
干预措施: Standard rehabilitation (Other)
Standard exercises with BFRT
Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises with BFRT during the three phases of standard rehabilitation.
干预措施: Blood Flow Restriction Therapy (Device)
Standard exercises alone
Participants with arthroscopic rotator cuff repair will undergo rehabilitation using progressive exercises without BFRT during the three phases of standard rehabilitation.
干预措施: Standard rehabilitation (Other)
结局指标
主要结局
Shoulder muscle strength
时间窗: 0, 4 and 12 weeks
Shoulder abduction and external rotation maximum voluntary isometric strength will be measured using dynamometry (kilograms)
Shoulder muscle mass
时间窗: 0, 4 and 12 weeks
Supraspinatus and long head biceps brachii tendon thickness will be measured using ultrasound imaging (milimeters)
次要结局
- Pain intensity(0, 4 and 12 weeks)
- Active Range of Motion(0, 4 and 12 weeks)
- Self-reported upper limb disability(0, 4 and 12 weeks)
- Self-reported quality of life(0, 4 and 12 weeks)
研究者
José Casaña Granell
PhD
University of Valencia