Efficacy of Blood Flow Restriction Training Combined With Eccentric Exercise as Assessed by Shear Wave Elastography in Subjects With Chronic Achilles Tendinopathy: A Randomized Single Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Shear Wave Elastography velocity
研究概览
简要总结
The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional self-report, and objective functional measures. SWE will be utilized to objectively quantify tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles tendinopathy.
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 (Participant, Outcomes Assessor)
盲法说明
Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.
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
- •Achilles pain for > 3 months
- •Unilateral symptoms only
- •DOD beneficiary, between the ages of 18 and 65
- •Clinical diagnosis of Achilles tendinopathy
- •Read and speak English well enough to provide informed consent and follow study instructions.
- •Can attend in-clinic treatments 2-3 x weekly for the next 12 weeks
排除标准
- •Any disease or disease process that would preclude the participant from safely performing any of the exercises or intervention at the discretion of the PI. (Uncontrolled diabetes, cardiac disease, severe COPD, open wounds, current infection, etc.)
- •Any LE surgery on either side in the last 2 years
- •History of Achilles rupture
- •Any vascular disorder (varicose veins, Hx of DVT)
- •Leaving post/station in the following 3 months precluding them being able to come in for f/u visits
- •Self-report of pregnancy (currently or within last 6 months)
- •Other foot/LE disorder that prevents the completion of the eccentric exercises or BFR exercise
- •Unable/unwilling to hop on symptomatic leg
- •Pain < 2/10 of average pain on NPRS
- •VISA A score > 80%
- •Currently going through MEB/worker's comp
研究组 & 干预措施
BFR Group
Blood Flow Restriction Training with Eccentric Exercise Protocol
干预措施: Blood Flow Restriction Training (Other)
BFR Group
Blood Flow Restriction Training with Eccentric Exercise Protocol
干预措施: Eccentric Exercise (Other)
Sham BFR Group
Sham Blood Flow Restriction Training with Eccentric Exercise Protocol
干预措施: Sham Blood Flow Restriction Training (Other)
Sham BFR Group
Sham Blood Flow Restriction Training with Eccentric Exercise Protocol
干预措施: Eccentric Exercise (Other)
结局指标
主要结局
Shear Wave Elastography velocity
时间窗: At baseline.
Difference between involved and uninvolved Achilles tendon
VISA-A
时间窗: From baseline to 24 weeks
Change in subjective self-report of Achilles function
次要结局
- Triple hop test(At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.)
- SL Calf Raise Endurance(At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.)
- SL Jump Height(At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.)
- Thigh Circumference(At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.)
- Calf Circumference(At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.)
- Numerical Pain Rating Scale(At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.)
- Global Rating of Change(At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.)
- Shear Wave Elastography velocity(Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.)