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

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

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.

Study Overview

• Status: Terminated
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Other: Blood Flow Restriction Training; Other: Eccentric Exercise; Other: Sham Blood Flow Restriction Training

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Fort Bragg, North Carolina, United States, 28310
      • Womack Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFR Group; Blood Flow Restriction Training with Eccentric Exercise Protocol	Other: Blood Flow Restriction Training; Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.; Other: Eccentric Exercise; Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
Sham Comparator: Sham BFR Group; Sham Blood Flow Restriction Training with Eccentric Exercise Protocol	Other: Eccentric Exercise; Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.; Other: Sham Blood Flow Restriction Training; Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shear Wave Elastography velocity	Difference between involved and uninvolved Achilles tendon	At baseline.
VISA-A	Change in subjective self-report of Achilles function	From baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triple hop test	Distance in length of 3 consecutive hops on one foot	At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Calf Raise Endurance	Number of single leg calf raises to failure	At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Jump Height	Distance in height of single leg jump	At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Thigh Circumference	circumferential measurement of thigh	At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Calf Circumference	circumferential measurement of calf	At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Numerical Pain Rating Scale	Pain level on a 0 to 10 scale	At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Global Rating of Change	15 point Likert scale from -7 to +7	At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Shear Wave Elastography velocity	Change in shear wave elastography of symptomatic Achilles tendon over time.	Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blinding/Group assignment assessment	Question asking which group they believe they are in (interventional vs control)	At 12 weeks and 24 weeks.

Collaborators and Investigators

• Sponsor: Womack Army Medical Center
• Collaborators: The Geneva Foundation; Telemedicine & Advanced Technology Research Center
• Investigators: Principal Investigator: Robert A Whitehurst, DPT, Womack Army Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): September 5, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 161202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No