<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/NCT03032432</url>
  </required_header>
  <id_info>
    <org_study_id>5160465</org_study_id>
    <nct_id>NCT03032432</nct_id>
  </id_info>
  <brief_title>A Dynamic Elastic Garment (DEG) in Patients With Rotator Cuff Tendinopathy</brief_title>
  <acronym>DEG</acronym>
  <official_title>A Single-blinded Randomized Controlled Trial Comparing Patients Who Receive a Corticosteroid Injection for Nontraumatic Degenerative Rotator Cuff Tears or Tendinopathy and Scheduled Use of a Dynamic Elastic Garment to Patients Who Receive a Corticosteroid Injection Alone.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if patients with shoulder pain and MRI-confirmed&#xD;
      rotator cuff tendinosis, will have their pain and function improved when treated with daily&#xD;
      use of a dynamic elastic garment along with a corticosteroid injection, when compared to&#xD;
      those patients who receive a corticosteroid injection alone. To our knowledge this is the&#xD;
      first study to evaluate the use of a dynamic elastic garment on shoulders.&#xD;
&#xD;
        -  Group A: Control group, will receive and ultrasound-guided corticosteroid injection&#xD;
           alone.&#xD;
&#xD;
        -  Group B: Intervention, ultrasound-guided corticosteroid injection and scheduled use of a&#xD;
           dynamic elastic garment, by IntelliSkin.&#xD;
&#xD;
        -  Group C: Intervention corticosteroid injection and scheduled use of a Dynamic elastic&#xD;
           garment, by AlignMed Posture Shirt 2.0.&#xD;
&#xD;
      Up to 60 patients will participate and be randomized in this study, both male and female&#xD;
      between the ages of 18 to 89 years of age. Subjects will complete a few forms; SF-36, ASES,&#xD;
      Simple Shoulder test, these will take place at the initial visit and Then again at your 4&#xD;
      week and 6 week visit.&#xD;
&#xD;
      This is a single center study, investigator initiated. 60 subjects will participate in the&#xD;
      study at Loma Linda University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder pain is a common complaint with a reported prevalence of 7-26% in the general&#xD;
      population(1). The most common etiology of shoulder pain in the primary care setting is&#xD;
      rotator cuff disease (2-4), a term which encompasses several separate diagnoses. In an&#xD;
      orthopaedic practice, rotator cuff disease includes tendinosis or tendinitis of the&#xD;
      supraspinatus, infraspinatus, subscapularis, or teres minor tendons, subacromial impingement&#xD;
      with or without bursitis, bicipital tendinitis, or a partial or complete rotator cuff tear.&#xD;
      This study will specifically include patients with tendinosis or tendinitis of the rotator&#xD;
      cuff, for which we will use the term rotator cuff tendinopathy.&#xD;
&#xD;
      There are myriad treatment options for rotator cuff tendinopathy; from conservative measures&#xD;
      such as NSAIDs, corticosteroid injections, and physiotherapy to more invasive measures&#xD;
      including arthroscopic decompression for subacromial impingement syndrome. While most&#xD;
      orthopaedic surgeons will employ some combination of physiotherapy, NSAIDs, and&#xD;
      corticosteroid injections for pain relief, the evidence supporting their efficacy in&#xD;
      providing long-term pain relief and functional improvement is limited. Thus, there is&#xD;
      clinical equipoise that exists when treating rotator cuff tendinopathy has led physicians to&#xD;
      pursue other less traditional modalities. Some of these that have gained notoriety are&#xD;
      hyperthermia, extracorporeal shock-wave treatment, electrotherapy modalities and more&#xD;
      recently, non-elastic taping and elastic kinesiology taping.&#xD;
&#xD;
      Dynamic elastic garments are relatively new products which are being used to improve posture&#xD;
      and provide shoulder and lumbar support. Abnormal scapular motion, particularly scapular&#xD;
      protraction, has been shown to reduce the subacromial width and place undue strain on the&#xD;
      rotator cuff. These garments utilize elastic bands placed in specific locations to provide&#xD;
      postural support and proprioceptive feedback to the patient. This may help to restore normal&#xD;
      shoulder kinematics and subsequently provide relief of shoulder symptoms.&#xD;
&#xD;
      Patients with MRI-confirmed tendinosis or tendinopathy of the rotator cuff will have improved&#xD;
      shoulder pain relief and outcome scores when treated with scheduled use of a dynamic- elastic&#xD;
      garment and a corticosteroid injection compared to those patients who receive a&#xD;
      corticosteroid injection alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Principle Investigator is no longer at Loma Linda University Medical Center&#xD;
  </why_stopped>
  <start_date type="Actual">June 12, 2018</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</primary_completion_date>
  <phase>Phase 4</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Form-36</measure>
    <time_frame>12 months</time_frame>
    <description>Short form Health questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test</measure>
    <time_frame>12 months</time_frame>
    <description>12 yes or no questions on function with the involved shoulder.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>American Shoulder and Elbow Surgeons Shoulder Assessment (ASES)</measure>
    <time_frame>12 months</time_frame>
    <description>Shoulder Function questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Rotator Cuff Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Dynamic elastic garment and injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Corticosteroid injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic Elastic Garment (DEG) brace</intervention_name>
    <description>Improve function of the shoulder</description>
    <arm_group_label>Dynamic elastic garment and injection</arm_group_label>
    <other_name>posture brace</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid injection</intervention_name>
    <description>Injection to improve rotator cuff tendinosis pain and functional score</description>
    <arm_group_label>Corticosteroid injection</arm_group_label>
    <arm_group_label>Dynamic elastic garment and injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 to 89 years of age with MRI-confirmed tendinosis of the rotator cuff&#xD;
             (supraspinatus, infraspinatus, subscapularis, or teres minor tendons) with pain on&#xD;
             clinical examination&#xD;
&#xD;
          -  Symptomatic, nontraumatic rotator cuff tears as confirmed on MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic onset of shoulder symptoms&#xD;
&#xD;
          -  Evidence of symptomatic glenohumeral osteoarthritis (osteophytes on plain films with&#xD;
             pain or stiffness on examination)&#xD;
&#xD;
          -  Partial or complete rotator cuff tears&#xD;
&#xD;
          -  Previous surgery on the affected shoulder&#xD;
&#xD;
          -  History of rheumatoid arthritis or other systemic inflammatory disorder&#xD;
&#xD;
          -  Use of immunosuppressive therapies in the last 6 months&#xD;
&#xD;
          -  Inability to comply with or properly document use of dynamic elastic garment for&#xD;
             prescribed time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nirav H Amin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Healthcare Department of Orthopaedic Surgery</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</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>
  <patient_data>
    <sharing_ipd>No</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/NCT03032432
org study id: 5160465
nct id: NCT03032432
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to determine if patients with shoulder pain and MRI-confirmed
      rotator cuff tendinosis, will have their pain and function improved when treated with daily
      use of a dynamic elastic garment along with a corticosteroid injection, when compared to
      those patients who receive a corticosteroid injection alone. To our knowledge this is the
      first study to evaluate the use of a dynamic elastic garment on shoulders.

        -  Group A: Control group, will receive and ultrasound-guided corticosteroid injection
           alone.

        -  Group B: Intervention, ultrasound-guided corticosteroid injection and scheduled use of a
           dynamic elastic garment, by IntelliSkin.

        -  Group C: Intervention corticosteroid injection and scheduled use of a Dynamic elastic
           garment, by AlignMed Posture Shirt 2.0.

      Up to 60 patients will participate and be randomized in this study, both male and female
      between the ages of 18 to 89 years of age. Subjects will complete a few forms; SF-36, ASES,
      Simple Shoulder test, these will take place at the initial visit and Then again at your 4
      week and 6 week visit.

      This is a single center study, investigator initiated. 60 subjects will participate in the
      study at Loma Linda University.
Shoulder pain is a common complaint with a reported prevalence of 7-26% in the general
      population(1). The most common etiology of shoulder pain in the primary care setting is
      rotator cuff disease (2-4), a term which encompasses several separate diagnoses. In an
      orthopaedic practice, rotator cuff disease includes tendinosis or tendinitis of the
      supraspinatus, infraspinatus, subscapularis, or teres minor tendons, subacromial impingement
      with or without bursitis, bicipital tendinitis, or a partial or complete rotator cuff tear.
      This study will specifically include patients with tendinosis or tendinitis of the rotator
      cuff, for which we will use the term rotator cuff tendinopathy.

      There are myriad treatment options for rotator cuff tendinopathy; from conservative measures
      such as NSAIDs, corticosteroid injections, and physiotherapy to more invasive measures
      including arthroscopic decompression for subacromial impingement syndrome. While most
      orthopaedic surgeons will employ some combination of physiotherapy, NSAIDs, and
      corticosteroid injections for pain relief, the evidence supporting their efficacy in
      providing long-term pain relief and functional improvement is limited. Thus, there is
      clinical equipoise that exists when treating rotator cuff tendinopathy has led physicians to
      pursue other less traditional modalities. Some of these that have gained notoriety are
      hyperthermia, extracorporeal shock-wave treatment, electrotherapy modalities and more
      recently, non-elastic taping and elastic kinesiology taping.

      Dynamic elastic garments are relatively new products which are being used to improve posture
      and provide shoulder and lumbar support. Abnormal scapular motion, particularly scapular
      protraction, has been shown to reduce the subacromial width and place undue strain on the
      rotator cuff. These garments utilize elastic bands placed in specific locations to provide
      postural support and proprioceptive feedback to the patient. This may help to restore normal
      shoulder kinematics and subsequently provide relief of shoulder symptoms.

      Patients with MRI-confirmed tendinosis or tendinopathy of the rotator cuff will have improved
      shoulder pain relief and outcome scores when treated with scheduled use of a dynamic- elastic
      garment and a corticosteroid injection compared to those patients who receive a
      corticosteroid injection alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Short Form-36
time frame: 12 months
description: Short form Health questionnaire
measure: Simple Shoulder Test
time frame: 12 months
description: 12 yes or no questions on function with the involved shoulder.
measure: American Shoulder and Elbow Surgeons Shoulder Assessment (ASES)
time frame: 12 months
description: Shoulder Function questionnaire
arm group label: Dynamic elastic garment and injection
arm group type: Experimental
arm group label: Corticosteroid injection
arm group type: Active Comparator
intervention type: Device
intervention name: Dynamic Elastic Garment (DEG) brace
description: Improve function of the shoulder
arm group label: Dynamic elastic garment and injection
other name: posture brace
intervention type: Drug
intervention name: Corticosteroid injection
description: Injection to improve rotator cuff tendinosis pain and functional score
arm group label: Corticosteroid injection
arm group label: Dynamic elastic garment and injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Nirav H Amin, MD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy
sharing ipd: No