Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT
- Conditions
- Achilles Tendinopathy
- Interventions
- Other: Blood Flow Restriction TrainingOther: Sham Blood Flow Restriction TrainingOther: Eccentric Exercise
- Registration Number
- NCT03264326
- Lead Sponsor
- Womack Army Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BFR Group Blood Flow Restriction Training Blood Flow Restriction Training with Eccentric Exercise Protocol Sham BFR Group Eccentric Exercise Sham Blood Flow Restriction Training with Eccentric Exercise Protocol Sham BFR Group Sham Blood Flow Restriction Training Sham Blood Flow Restriction Training with Eccentric Exercise Protocol BFR Group Eccentric Exercise Blood Flow Restriction Training with Eccentric Exercise Protocol
- Primary Outcome Measures
Name Time Method Shear Wave Elastography velocity At baseline. Difference between involved and uninvolved Achilles tendon
VISA-A From baseline to 24 weeks Change in subjective self-report of Achilles function
- Secondary Outcome Measures
Name Time Method Triple hop test At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. Distance in length of 3 consecutive hops on one foot
SL Calf Raise Endurance At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. Number of single leg calf raises to failure
SL Jump Height At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. Distance in height of single leg jump
Thigh Circumference At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. circumferential measurement of thigh
Calf Circumference At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. circumferential measurement of calf
Numerical Pain Rating Scale At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. Pain level on a 0 to 10 scale
Global Rating of Change At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. 15 point Likert scale from -7 to +7
Shear Wave Elastography velocity Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks. Change in shear wave elastography of symptomatic Achilles tendon over time.
Trial Locations
- Locations (1)
Womack Army Medical Center
🇺🇸Fort Bragg, North Carolina, United States