Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT

Womack Army Medical Center (WAMC)

Status: Terminated

Conditions: Achilles Tendinopathy

Treatments: Other: Blood Flow Restriction Training; Other: Eccentric Exercise; Other: Sham Blood Flow Restriction Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03264326

161202

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

BFR Group

Experimental group

Description:

Blood Flow Restriction Training with Eccentric Exercise Protocol

Treatment:

Other: Blood Flow Restriction Training

Other: Eccentric Exercise

Sham BFR Group

Sham Comparator group

Description:

Sham Blood Flow Restriction Training with Eccentric Exercise Protocol

Treatment:

Other: Sham Blood Flow Restriction Training

Other: Eccentric Exercise