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

Primary Purpose

Achilles Tendinopathy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Training
Sham Blood Flow Restriction Training
Eccentric Exercise
Sponsored by
Womack Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Womack Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

BFR Group

Sham BFR Group

Arm Description

Blood Flow Restriction Training with Eccentric Exercise Protocol

Sham Blood Flow Restriction Training with Eccentric Exercise Protocol

Outcomes

Primary Outcome Measures

Shear Wave Elastography velocity
Difference between involved and uninvolved Achilles tendon
VISA-A
Change in subjective self-report of Achilles function

Secondary Outcome Measures

Triple hop test
Distance in length of 3 consecutive hops on one foot
SL Calf Raise Endurance
Number of single leg calf raises to failure
SL Jump Height
Distance in height of single leg jump
Thigh Circumference
circumferential measurement of thigh
Calf Circumference
circumferential measurement of calf
Numerical Pain Rating Scale
Pain level on a 0 to 10 scale
Global Rating of Change
15 point Likert scale from -7 to +7
Shear Wave Elastography velocity
Change in shear wave elastography of symptomatic Achilles tendon over time.

Full Information

First Posted
August 2, 2017
Last Updated
May 13, 2019
Sponsor
Womack Army Medical Center
Collaborators
The Geneva Foundation, Telemedicine & Advanced Technology Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03264326
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator left institution and not enough resources to support at MTF
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Womack Army Medical Center
Collaborators
The Geneva Foundation, Telemedicine & Advanced Technology Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFR Group
Arm Type
Experimental
Arm Description
Blood Flow Restriction Training with Eccentric Exercise Protocol
Arm Title
Sham BFR Group
Arm Type
Sham Comparator
Arm Description
Sham Blood Flow Restriction Training with Eccentric Exercise Protocol
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction Training
Intervention Description
Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.
Intervention Type
Other
Intervention Name(s)
Sham Blood Flow Restriction Training
Intervention Description
Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise
Intervention Description
Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
Primary Outcome Measure Information:
Title
Shear Wave Elastography velocity
Description
Difference between involved and uninvolved Achilles tendon
Time Frame
At baseline.
Title
VISA-A
Description
Change in subjective self-report of Achilles function
Time Frame
From baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Triple hop test
Description
Distance in length of 3 consecutive hops on one foot
Time Frame
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Title
SL Calf Raise Endurance
Description
Number of single leg calf raises to failure
Time Frame
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Title
SL Jump Height
Description
Distance in height of single leg jump
Time Frame
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Title
Thigh Circumference
Description
circumferential measurement of thigh
Time Frame
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Title
Calf Circumference
Description
circumferential measurement of calf
Time Frame
At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Title
Numerical Pain Rating Scale
Description
Pain level on a 0 to 10 scale
Time Frame
At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Title
Global Rating of Change
Description
15 point Likert scale from -7 to +7
Time Frame
At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Title
Shear Wave Elastography velocity
Description
Change in shear wave elastography of symptomatic Achilles tendon over time.
Time Frame
Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.
Other Pre-specified Outcome Measures:
Title
Blinding/Group assignment assessment
Description
Question asking which group they believe they are in (interventional vs control)
Time Frame
At 12 weeks and 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Whitehurst, DPT
Organizational Affiliation
Womack Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States

12. IPD Sharing Statement

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

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