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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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ClinicalTrials.gov Identifier: NCT03264326
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
The Geneva Foundation
Telemedicine & Advanced Technology Research Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Other: Blood Flow Restriction Training Other: Sham Blood Flow Restriction Training Other: Eccentric Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.
Primary Purpose: Treatment
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
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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: Sham Blood Flow Restriction Training
Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.

Other: Eccentric Exercise
Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.




Primary Outcome Measures :
  1. Shear Wave Elastography velocity [ Time Frame: At baseline. ]
    Difference between involved and uninvolved Achilles tendon

  2. VISA-A [ Time Frame: From baseline to 24 weeks ]
    Change in subjective self-report of Achilles function


Secondary Outcome Measures :
  1. Triple hop test [ Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. ]
    Distance in length of 3 consecutive hops on one foot

  2. SL Calf Raise Endurance [ Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. ]
    Number of single leg calf raises to failure

  3. SL Jump Height [ Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. ]
    Distance in height of single leg jump

  4. Thigh Circumference [ Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. ]
    circumferential measurement of thigh

  5. Calf Circumference [ Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. ]
    circumferential measurement of calf

  6. Numerical Pain Rating Scale [ Time Frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. ]
    Pain level on a 0 to 10 scale

  7. Global Rating of Change [ Time Frame: At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. ]
    15 point Likert scale from -7 to +7

  8. Shear Wave Elastography velocity [ Time Frame: Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks. ]
    Change in shear wave elastography of symptomatic Achilles tendon over time.


Other Outcome Measures:
  1. Blinding/Group assignment assessment [ Time Frame: At 12 weeks and 24 weeks. ]
    Question asking which group they believe they are in (interventional vs control)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264326


Contacts
Contact: Robert A Whitehurst, DPT 910-907-8865 robert.a.whitehurst7.mil@mail.mil
Contact: Christy Crawford 910-907-6277 christy.c.crawford.civ@mail.mil

Locations
United States, North Carolina
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28310
Contact: Robert A Whitehurst, DPT    910-907-8865    robert.a.whitehurst7.mil@mail.mil   
Sponsors and Collaborators
Womack Army Medical Center
The Geneva Foundation
Telemedicine & Advanced Technology Research Center
Investigators
Principal Investigator: Robert A Whitehurst, DPT Womack Army Medical Center

Responsible Party: Womack Army Medical Center
ClinicalTrials.gov Identifier: NCT03264326     History of Changes
Other Study ID Numbers: 161202
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries