<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/NCT04503421</url>
  </required_header>
  <id_info>
    <org_study_id>Henry - IRB00000253</org_study_id>
    <nct_id>NCT04503421</nct_id>
  </id_info>
  <brief_title>Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair</brief_title>
  <official_title>Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</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 goal of this investigation is to determine if using BFR during postoperative therapy&#xD;
      would lead to increased and expedited strength gains. Additionally, the investigators would&#xD;
      like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in&#xD;
      the setting of bicep tendon tears, due to the altered tension-length relationship following&#xD;
      surgery. The study will also look at patient reported outcomes metrics and pain scores to&#xD;
      determine if BFR has a significant impact on the patient experience surrounding distal biceps&#xD;
      tear and surgical repair&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>1 week post-operatively</time_frame>
    <description>measured via dynamometer (pounds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>6 weeks post-operatively</time_frame>
    <description>measured via dynamometer (pounds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>measured via dynamometer (pounds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>measured via dynamometer (pounds)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>1 week post-operatively</time_frame>
    <description>via goniometer (degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>6 week post-operatively</time_frame>
    <description>via goniometer (degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>via goniometer (degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>via goniometer (degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Pain</measure>
    <time_frame>1 week post-operatively</time_frame>
    <description>via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Pain</measure>
    <time_frame>6 week post-operatively</time_frame>
    <description>via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Pain</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Pain</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>1 week post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>1 week post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>1 week post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>6 week post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>6 week post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>6 week post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome scores</measure>
    <time_frame>6 months post-operatively</time_frame>
    <description>via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Bicep Tendon Rupture</condition>
  <arm_group>
    <arm_group_label>BFR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will use the following rehabilitation protocol while incorporating blood flow restriction therapy:&#xD;
Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only&#xD;
Sling immobilization with active wrist and shoulder ROM&#xD;
Active extension of biceps to 30 degrees, No active flexion&#xD;
6-9 weeks full active extension in brace&#xD;
Maintain wrist and shoulder flexibility&#xD;
Begin rotator cuff/deltoid isometrics, progress active extension in brace&#xD;
Weeks 9-12: Gently advance ROM to tolerance&#xD;
Discontinue sling&#xD;
Begin active flexion and extension against gravity.&#xD;
Advance strength to light resistance, maintain flexibility/ROM&#xD;
Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (no BFR)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients will use following rehabilitation protocol without the use of blood flow restriction therapy:&#xD;
Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only&#xD;
Sling immobilization with active wrist and shoulder ROM&#xD;
Active extension of biceps to 30 degrees, No active flexion&#xD;
6-9 weeks full active extension in brace&#xD;
Maintain wrist and shoulder flexibility&#xD;
Begin rotator cuff/deltoid isometrics, progress active extension in brace&#xD;
Weeks 9-12: Gently advance ROM to tolerance&#xD;
Discontinue sling&#xD;
Begin active flexion and extension against gravity.&#xD;
Advance strength to light resistance, maintain flexibility/ROM&#xD;
Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Flow Restriction Therapy</intervention_name>
    <description>Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy</description>
    <arm_group_label>BFR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  Undergoing distal biceps tendon repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision Biceps tendon repair,&#xD;
&#xD;
          -  Irrepairable tendon injury,&#xD;
&#xD;
          -  Biceps repairs with biologic augmentation,&#xD;
&#xD;
          -  Patients with concomitant neurovascular injury,&#xD;
&#xD;
          -  Inability to tolerate BFR treatment,&#xD;
&#xD;
          -  Unable to complete full course of physical therapy,&#xD;
&#xD;
          -  Peripheral vascular disease,&#xD;
&#xD;
          -  History of Venous thromboembolism (VTE)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Health Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toufic R Jildeh, MD</last_name>
      <phone>517-230-8511</phone>
      <email>touficjildeh@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.</citation>
    <PMID>18466185</PMID>
  </reference>
  <reference>
    <citation>Huynh T, Leiter J, MacDonald PB, Dubberley J, Stranges G, Old J, Marsh J. Outcomes and Complications After Repair of Complete Distal Biceps Tendon Rupture with the Cortical Button Technique. JB JS Open Access. 2019 Aug 27;4(3):e0013.1-6. doi: 10.2106/JBJS.OA.19.00013. eCollection 2019 Jul-Sep.</citation>
    <PMID>31592499</PMID>
  </reference>
  <reference>
    <citation>Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.</citation>
    <PMID>12635796</PMID>
  </reference>
  <reference>
    <citation>Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.</citation>
    <PMID>11128848</PMID>
  </reference>
  <reference>
    <citation>Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.</citation>
    <PMID>21917016</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Toufic R. Jildeh</investigator_full_name>
    <investigator_title>Orthopedic Sports Medicine Surgeon at Henry Ford Health System</investigator_title>
  </responsible_party>
  <keyword>blood flow restriction</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04503421
org study id: Henry - IRB00000253
nct id: NCT04503421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this investigation is to determine if using BFR during postoperative therapy
      would lead to increased and expedited strength gains. Additionally, the investigators would
      like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in
      the setting of bicep tendon tears, due to the altered tension-length relationship following
      surgery. The study will also look at patient reported outcomes metrics and pain scores to
      determine if BFR has a significant impact on the patient experience surrounding distal biceps
      tear and surgical repair
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Strength
time frame: 1 week post-operatively
description: measured via dynamometer (pounds)
measure: Strength
time frame: 6 weeks post-operatively
description: measured via dynamometer (pounds)
measure: Strength
time frame: 3 months post-operatively
description: measured via dynamometer (pounds)
measure: Strength
time frame: 6 months post-operatively
description: measured via dynamometer (pounds)
measure: Range of Motion
time frame: 1 week post-operatively
description: via goniometer (degrees)
measure: Range of Motion
time frame: 6 week post-operatively
description: via goniometer (degrees)
measure: Range of Motion
time frame: 3 months post-operatively
description: via goniometer (degrees)
measure: Range of Motion
time frame: 6 months post-operatively
description: via goniometer (degrees)
measure: Perceived Pain
time frame: 1 week post-operatively
description: via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
measure: Perceived Pain
time frame: 6 week post-operatively
description: via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
measure: Perceived Pain
time frame: 3 months post-operatively
description: via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
measure: Perceived Pain
time frame: 6 months post-operatively
description: via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
measure: Patient reported outcome scores
time frame: 1 week post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
measure: Patient reported outcome scores
time frame: 1 week post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
measure: Patient reported outcome scores
time frame: 1 week post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
measure: Patient reported outcome scores
time frame: 6 week post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
measure: Patient reported outcome scores
time frame: 6 week post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
measure: Patient reported outcome scores
time frame: 6 week post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
measure: Patient reported outcome scores
time frame: 3 months post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
measure: Patient reported outcome scores
time frame: 3 months post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
measure: Patient reported outcome scores
time frame: 3 months post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
measure: Patient reported outcome scores
time frame: 6 months post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
measure: Patient reported outcome scores
time frame: 6 months post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
measure: Patient reported outcome scores
time frame: 6 months post-operatively
description: via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
arm group label: BFR
arm group type: Experimental
description: Patient will use the following rehabilitation protocol while incorporating blood flow restriction therapy:
Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only
Sling immobilization with active wrist and shoulder ROM
Active extension of biceps to 30 degrees, No active flexion
6-9 weeks full active extension in brace
Maintain wrist and shoulder flexibility
Begin rotator cuff/deltoid isometrics, progress active extension in brace
Weeks 9-12: Gently advance ROM to tolerance
Discontinue sling
Begin active flexion and extension against gravity.
Advance strength to light resistance, maintain flexibility/ROM
Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated
arm group label: Control (no BFR)
arm group type: No Intervention
description: patients will use following rehabilitation protocol without the use of blood flow restriction therapy:
Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only
Sling immobilization with active wrist and shoulder ROM
Active extension of biceps to 30 degrees, No active flexion
6-9 weeks full active extension in brace
Maintain wrist and shoulder flexibility
Begin rotator cuff/deltoid isometrics, progress active extension in brace
Weeks 9-12: Gently advance ROM to tolerance
Discontinue sling
Begin active flexion and extension against gravity.
Advance strength to light resistance, maintain flexibility/ROM
Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated
intervention type: Other
intervention name: Blood Flow Restriction Therapy
description: Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
arm group label: BFR
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United States
citation: Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.
PMID: 18466185
citation: Huynh T, Leiter J, MacDonald PB, Dubberley J, Stranges G, Old J, Marsh J. Outcomes and Complications After Repair of Complete Distal Biceps Tendon Rupture with the Cortical Button Technique. JB JS Open Access. 2019 Aug 27;4(3):e0013.1-6. doi: 10.2106/JBJS.OA.19.00013. eCollection 2019 Jul-Sep.
PMID: 31592499
citation: Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
PMID: 12635796
citation: Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.
PMID: 11128848
citation: Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.
PMID: 21917016
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Toufic R. Jildeh
investigator title: Orthopedic Sports Medicine Surgeon at Henry Ford Health System
mesh term: Rupture
sharing ipd: Undecided