Clinical trial NCT03264326: Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Achilles Tendinopathy
Lead sponsor: Womack Army Medical Center
Sponsor class: FED
Collaborators: name: The Geneva Foundation
name: Telemedicine & Advanced Technology Research Center
First posted: 2017-08-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Shear Wave Elastography velocity
timeFrame: At baseline.
measure: VISA-A
timeFrame: From baseline to 24 weeks
Secondary outcomes:
measure: Triple hop test
timeFrame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
measure: SL Calf Raise Endurance
timeFrame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
measure: SL Jump Height
timeFrame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
measure: Thigh Circumference
timeFrame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
measure: Calf Circumference
timeFrame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
measure: Numerical Pain Rating Scale
timeFrame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
measure: Global Rating of Change
timeFrame: At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
measure: Shear Wave Elastography velocity
timeFrame: Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.
Other outcomes:
measure: Blinding/Group assignment assessment
timeFrame: At 12 weeks and 24 weeks.
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: Womack Army Medical Center
name: Robert A Whitehurst, DPT
role: PRINCIPAL_INVESTIGATOR
References: