<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264326</url>
  </required_header>
  <id_info>
    <org_study_id>161202</org_study_id>
    <nct_id>NCT03264326</nct_id>
  </id_info>
  <brief_title>Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Womack Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Geneva Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Telemedicine &amp; Advanced Technology Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Womack Army Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to&#xD;
      assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training&#xD;
      in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional&#xD;
      self-report, and objective functional measures. SWE will be utilized to objectively quantify&#xD;
      tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles&#xD;
      tendinopathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal Investigator left institution and not enough resources to support at MTF&#xD;
  </why_stopped>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Shear Wave Elastography velocity</measure>
    <time_frame>At baseline.</time_frame>
    <description>Difference between involved and uninvolved Achilles tendon</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VISA-A</measure>
    <time_frame>From baseline to 24 weeks</time_frame>
    <description>Change in subjective self-report of Achilles function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Triple hop test</measure>
    <time_frame>At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.</time_frame>
    <description>Distance in length of 3 consecutive hops on one foot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SL Calf Raise Endurance</measure>
    <time_frame>At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.</time_frame>
    <description>Number of single leg calf raises to failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SL Jump Height</measure>
    <time_frame>At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.</time_frame>
    <description>Distance in height of single leg jump</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh Circumference</measure>
    <time_frame>At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.</time_frame>
    <description>circumferential measurement of thigh</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calf Circumference</measure>
    <time_frame>At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.</time_frame>
    <description>circumferential measurement of calf</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Pain Rating Scale</measure>
    <time_frame>At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.</time_frame>
    <description>Pain level on a 0 to 10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change</measure>
    <time_frame>At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.</time_frame>
    <description>15 point Likert scale from -7 to +7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shear Wave Elastography velocity</measure>
    <time_frame>Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.</time_frame>
    <description>Change in shear wave elastography of symptomatic Achilles tendon over time.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blinding/Group assignment assessment</measure>
    <time_frame>At 12 weeks and 24 weeks.</time_frame>
    <description>Question asking which group they believe they are in (interventional vs control)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Achilles Tendinopathy</condition>
  <arm_group>
    <arm_group_label>BFR Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood Flow Restriction Training with Eccentric Exercise Protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham BFR Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Blood Flow Restriction Training with Eccentric Exercise Protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Flow Restriction Training</intervention_name>
    <description>Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.</description>
    <arm_group_label>BFR Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Blood Flow Restriction Training</intervention_name>
    <description>Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.</description>
    <arm_group_label>Sham BFR Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eccentric Exercise</intervention_name>
    <description>Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.</description>
    <arm_group_label>BFR Group</arm_group_label>
    <arm_group_label>Sham BFR Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Achilles pain for &gt; 3 months&#xD;
&#xD;
          -  Unilateral symptoms only&#xD;
&#xD;
          -  DOD beneficiary, between the ages of 18 and 65&#xD;
&#xD;
          -  Clinical diagnosis of Achilles tendinopathy&#xD;
&#xD;
          -  Read and speak English well enough to provide informed consent and follow study&#xD;
             instructions.&#xD;
&#xD;
          -  Can attend in-clinic treatments 2-3 x weekly for the next 12 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any disease or disease process that would preclude the participant from safely&#xD;
             performing any of the exercises or intervention at the discretion of the PI.&#xD;
             (Uncontrolled diabetes, cardiac disease, severe COPD, open wounds, current infection,&#xD;
             etc.)&#xD;
&#xD;
          -  Any LE surgery on either side in the last 2 years&#xD;
&#xD;
          -  History of Achilles rupture&#xD;
&#xD;
          -  Any vascular disorder (varicose veins, Hx of DVT)&#xD;
&#xD;
          -  Leaving post/station in the following 3 months precluding them being able to come in&#xD;
             for f/u visits&#xD;
&#xD;
          -  Self-report of pregnancy (currently or within last 6 months)&#xD;
&#xD;
          -  Other foot/LE disorder that prevents the completion of the eccentric exercises or BFR&#xD;
             exercise&#xD;
&#xD;
          -  Unable/unwilling to hop on symptomatic leg&#xD;
&#xD;
          -  Pain &lt; 2/10 of average pain on NPRS&#xD;
&#xD;
          -  VISA A score &gt; 80%&#xD;
&#xD;
          -  Currently going through MEB/worker's comp&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert A Whitehurst, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Womack Army Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Womack Army Medical Center</name>
      <address>
        <city>Fort Bragg</city>
        <state>North Carolina</state>
        <zip>28310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264326
org study id: 161202
nct id: NCT03264326
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.
measure: Shear Wave Elastography velocity
time frame: At baseline.
description: Difference between involved and uninvolved Achilles tendon
measure: VISA-A
time frame: From baseline to 24 weeks
description: Change in subjective self-report of Achilles function
measure: Triple hop test
time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
description: Distance in length of 3 consecutive hops on one foot
measure: SL Calf Raise Endurance
time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
description: Number of single leg calf raises to failure
measure: SL Jump Height
time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
description: Distance in height of single leg jump
measure: Thigh Circumference
time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
description: circumferential measurement of thigh
measure: Calf Circumference
time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
description: circumferential measurement of calf
measure: Numerical Pain Rating Scale
time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
description: Pain level on a 0 to 10 scale
measure: Global Rating of Change
time frame: At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
description: 15 point Likert scale from -7 to +7
measure: Shear Wave Elastography velocity
time frame: Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.
description: Change in shear wave elastography of symptomatic Achilles tendon over time.
measure: Blinding/Group assignment assessment
time frame: At 12 weeks and 24 weeks.
description: Question asking which group they believe they are in (interventional vs control)
arm group label: BFR Group
arm group type: Experimental
description: Blood Flow Restriction Training with Eccentric Exercise Protocol
arm group label: Sham BFR Group
arm group type: Sham Comparator
description: Sham Blood Flow Restriction Training with Eccentric Exercise Protocol
intervention type: Other
intervention name: Blood Flow Restriction Training
description: Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.
arm group label: BFR Group
intervention type: Other
intervention name: Sham Blood Flow Restriction Training
description: Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.
arm group label: Sham BFR Group
intervention type: Other
intervention name: Eccentric Exercise
description: Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
arm group label: BFR Group
arm group label: Sham BFR Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Robert A Whitehurst, DPT
role: Principal Investigator
affiliation: Womack Army Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy