Exercise-induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: a Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pressure pain threshold (PPT)
研究概览
简要总结
The goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. It is presumed that the addition of BFR to isometric exercises induces a greater effect in EIH.
Patients who agree to participate in this research will be randomly assigned to two intervention sequences (AB or BA), where intervention A (experimental) corresponds to isometric exercises with BFR, and intervention B (control) corresponds to isometric exercises alone. For one week, each participant attended two sessions, separated by a 72-hours wash-out period. The primary variables will be the pressure pain threshold (PPT) and conditioned pain modulation (CPM). Secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. Results will be measured before intervention (T1, pre-intervention), immediate after intervention (T2, post-intervention 1) and 10 minutes after intervention (T3, post-intervention 2).
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)
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 RC tears, concomitant fracture, labral or nerve injury.
- •Suspicion of developing/diagnosis a frozen shoulder.
- •Revision surgery after RC repair.
- •Previous corticosteroid injection (< 1 year).
- •Recent surgery (< 1 year) in the contralateral shoulder.
- •A history of deep venous thrombosis/pulmonary embolism.
- •Peripheral vascular disease, thrombophilia or clotting disorders.
- •Severe or uncontrolled hypertension, or any comorbid condition that prevents participants from complete the intervention.
研究组 & 干预措施
Isometric exercises with BFR (Intervention A)
Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises with BFR
干预措施: Isometric exercises (Other)
Isometric exercises with BFR (Intervention A)
Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises with BFR
干预措施: Isometric exercises with BFR (Device)
Isometric exercises alone (Intervention B)
Participants with arthroscopic rotator cuff repair will undergo to a physical therapy session using three isometric exercises without BFR
干预措施: Isometric exercises (Other)
结局指标
主要结局
Pressure pain threshold (PPT)
时间窗: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Pressure pain threshold will be taken bilaterally on the deltoid muscle and the upper trapezius muscle using a Wagner FPX25 pressure algometer (kg/cm2/sec)
Condicionated pain modulation (CPM)
时间窗: Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3)
Condicionated pain modulation will be measured with a conditioning stimulus of inmersion of the hand contralateral to the operated shoulder in cold water (10°C). The bilateral deltoid and trapezius muscles before and after the conditioning stimulus will be measured using a Wagner FPX25 pressure algometer (kg/cm2/sec)
次要结局
- Kinesiophobia(Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3))
- Pain intensity and distribution(Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3))
- Self-reported upper extremity disability(Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3))
- Self-reported quality of life(Pre-intervention (T1), inmediate post-intervention (T2) and 10 minutes post-intervention (T3))
研究者
José Casaña Granell
Professor of Physiotherapy
University of Valencia