<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/NCT02971072</url>
  </required_header>
  <id_info>
    <org_study_id>05022014.005</org_study_id>
    <secondary_id>1R01AR063713-01A1</secondary_id>
    <nct_id>NCT02971072</nct_id>
  </id_info>
  <brief_title>Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy</brief_title>
  <official_title>Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oregon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oregon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine deficits in activation and motor patterns, as well as&#xD;
      central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1)&#xD;
      determine the effect of acute pain relief on rotator cuff muscle activation in patients with&#xD;
      rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle&#xD;
      activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle&#xD;
      activation between patients with rotator cuff tendinopathy and healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The long-term goal of our research agenda is to identify the mechanisms associated with&#xD;
      rotator cuff tendinopathy (impingement syndrome) and subsequently evaluate novel treatment&#xD;
      strategies that address these mechanisms. The objectives of this application are to study the&#xD;
      muscle patterns in patients with rotator cuff tendinopathy as well as the effects of both&#xD;
      pain and exercise on these patterns. Our first hypothesis is that pain relief from a shoulder&#xD;
      injection will result in increased rotator cuff activity. Our second hypothesis is that&#xD;
      patients with tendinopathy will demonstrate improved rotator cuff muscle activity following a&#xD;
      six-week exercise program and that this improvement will be higher in patients that respond&#xD;
      favorably to treatment. Our final hypothesis is that patients with cuff tendinopathy will&#xD;
      show decreased rotator cuff activity compared to healthy subjects. The investigators plan on&#xD;
      addressing these hypotheses using several novel techniques for muscle activity assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">April 2021</completion_date>
  <primary_completion_date type="Actual">April 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using voluntary activation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using electromyography (EMG)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff voluntary activation after subacromial injection</measure>
    <time_frame>2 hours</time_frame>
    <description>Assessed using voluntary activation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff muscle activation after subacromial injection</measure>
    <time_frame>2 hours</time_frame>
    <description>Assessed using EMG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff voluntary activation correlations with pain levels</measure>
    <time_frame>2 hours</time_frame>
    <description>Assessed using voluntary activation relative to self-reported pain level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff activation correlations with pain levels</measure>
    <time_frame>2 hours</time_frame>
    <description>Assessed using EMG relative to self-reported pain level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using voluntary activation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using EMG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff voluntary activation correlation with improvements in pain relief</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using voluntary activation relative to self-reported pain relief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff voluntary activation correlation with improvements in clinical outcome measures</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using voluntary activation relative to changes in questionnaire scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff muscle activation correlation with improvements in pain relief</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using EMG relative to self-reported pain relief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator cuff muscle activation correlation with improvements in clinical outcome measures</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using EMG relative to changes in questionnaire scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using voluntary activation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using EMG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using voluntary activation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed using EMG</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Acute Pain</condition>
  <condition>Atrophic</condition>
  <condition>Goals</condition>
  <condition>Impairment</condition>
  <condition>Infiltration</condition>
  <condition>Injury</condition>
  <condition>Muscle Weakness</condition>
  <condition>Pain</condition>
  <condition>Pathology</condition>
  <condition>Shoulder Pain</condition>
  <condition>Syndrome</condition>
  <condition>Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subacromial injection</intervention_name>
    <description>A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <description>A standardized six-week exercise protocol supervised by a physical therapist</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  pain with passive provocative maneuvers (positive Hawkins or Neer test)&#xD;
&#xD;
          -  pain with active elevation (positive painful arc)&#xD;
&#xD;
          -  pain with isometric resisted movements (Jobe's &quot;empty can&quot; test or resisted shoulder&#xD;
             external rotation with the arm at the side)&#xD;
&#xD;
          -  demonstrate weakness (&gt;10% force deficit in external rotation)&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  shoulder surgery on the symptomatic side&#xD;
&#xD;
          -  positive Spurling test&#xD;
&#xD;
          -  traumatic shoulder dislocation or instability in the past 3 months&#xD;
&#xD;
          -  reproduction of shoulder pain with active or passive cervical range of motion&#xD;
&#xD;
          -  signs of rotator cuff tear (drop-arm test, lag signs, gross external rotation&#xD;
             weakness, or positive image findings)&#xD;
&#xD;
          -  current musculoskeletal, neurologic or cardiovascular compromise&#xD;
&#xD;
        Control Inclusion Criteria:&#xD;
&#xD;
          -  no current or previous shoulder injury&#xD;
&#xD;
          -  matched for age (within 5 years) and sex&#xD;
&#xD;
          -  meet Patient Exclusion Criteria (minus musculoskeletal, neurologic, or cardiovascular&#xD;
             compromise)&#xD;
&#xD;
        Control Exclusion Criteria:&#xD;
&#xD;
          -  pain with active arm elevation&#xD;
&#xD;
          -  positive Hawkins, Neer, or Jobe's test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew R Karduna, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oregon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oregon</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>May 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>address</keyword>
  <keyword>atrophic</keyword>
  <keyword>base</keyword>
  <keyword>clinical</keyword>
  <keyword>cost</keyword>
  <keyword>data</keyword>
  <keyword>disability</keyword>
  <keyword>effectiveness</keyword>
  <keyword>attention</keyword>
  <keyword>biofeedback</keyword>
  <keyword>electrical stimulation</keyword>
  <keyword>electromyography</keyword>
  <keyword>exercise</keyword>
  <keyword>exertion</keyword>
  <keyword>health care service utilization</keyword>
  <keyword>improved</keyword>
  <keyword>injection of therapeutic agent</keyword>
  <keyword>innovation</keyword>
  <keyword>intervention</keyword>
  <keyword>knowledge</keyword>
  <keyword>local anesthetics</keyword>
  <keyword>measures</keyword>
  <keyword>modeling</keyword>
  <keyword>motor</keyword>
  <keyword>motor control</keyword>
  <keyword>muscle</keyword>
  <keyword>neuroadaptation</keyword>
  <keyword>neurophysiology</keyword>
  <keyword>novel</keyword>
  <keyword>outcome</keyword>
  <keyword>outcome measure</keyword>
  <keyword>pain inhibition</keyword>
  <keyword>patients</keyword>
  <keyword>pattern</keyword>
  <keyword>programs</keyword>
  <keyword>public health relevance</keyword>
  <keyword>rehabilitation strategy</keyword>
  <keyword>relating to nervous system</keyword>
  <keyword>reporting</keyword>
  <keyword>research</keyword>
  <keyword>rotator cuff</keyword>
  <keyword>shoulder</keyword>
  <keyword>staging</keyword>
  <keyword>strength training</keyword>
  <keyword>success</keyword>
  <keyword>systematic review</keyword>
  <keyword>techniques</keyword>
  <keyword>testing</keyword>
  <keyword>time</keyword>
  <keyword>training</keyword>
  <keyword>treatment strategy</keyword>
  <keyword>United States</keyword>
  <keyword>work</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Asthenia</mesh_term>
    <mesh_term>Atrophy</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/NCT02971072
org study id: 05022014.005
secondary id: 1R01AR063713-01A1
nct id: NCT02971072
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to examine deficits in activation and motor patterns, as well as
      central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1)
      determine the effect of acute pain relief on rotator cuff muscle activation in patients with
      rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle
      activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle
      activation between patients with rotator cuff tendinopathy and healthy controls.
The long-term goal of our research agenda is to identify the mechanisms associated with
      rotator cuff tendinopathy (impingement syndrome) and subsequently evaluate novel treatment
      strategies that address these mechanisms. The objectives of this application are to study the
      muscle patterns in patients with rotator cuff tendinopathy as well as the effects of both
      pain and exercise on these patterns. Our first hypothesis is that pain relief from a shoulder
      injection will result in increased rotator cuff activity. Our second hypothesis is that
      patients with tendinopathy will demonstrate improved rotator cuff muscle activity following a
      six-week exercise program and that this improvement will be higher in patients that respond
      favorably to treatment. Our final hypothesis is that patients with cuff tendinopathy will
      show decreased rotator cuff activity compared to healthy subjects. The investigators plan on
      addressing these hypotheses using several novel techniques for muscle activity assessment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls
time frame: 6 weeks
description: Assessed using voluntary activation
measure: Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls
time frame: 6 weeks
description: Assessed using electromyography (EMG)
measure: Rotator cuff voluntary activation after subacromial injection
time frame: 2 hours
description: Assessed using voluntary activation
measure: Rotator cuff muscle activation after subacromial injection
time frame: 2 hours
description: Assessed using EMG
measure: Rotator cuff voluntary activation correlations with pain levels
time frame: 2 hours
description: Assessed using voluntary activation relative to self-reported pain level
measure: Rotator cuff activation correlations with pain levels
time frame: 2 hours
description: Assessed using EMG relative to self-reported pain level
measure: Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection
time frame: 6 weeks
description: Assessed using voluntary activation
measure: Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection
time frame: 6 weeks
description: Assessed using EMG
measure: Rotator cuff voluntary activation correlation with improvements in pain relief
time frame: 6 weeks
description: Assessed using voluntary activation relative to self-reported pain relief
measure: Rotator cuff voluntary activation correlation with improvements in clinical outcome measures
time frame: 6 weeks
description: Assessed using voluntary activation relative to changes in questionnaire scores
measure: Rotator cuff muscle activation correlation with improvements in pain relief
time frame: 6 weeks
description: Assessed using EMG relative to self-reported pain relief
measure: Rotator cuff muscle activation correlation with improvements in clinical outcome measures
time frame: 6 weeks
description: Assessed using EMG relative to changes in questionnaire scores
measure: Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls
time frame: 6 weeks
description: Assessed using voluntary activation
measure: Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls
time frame: 6 weeks
description: Assessed using EMG
measure: After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls
time frame: 6 weeks
description: Assessed using voluntary activation
measure: After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls
time frame: 6 weeks
description: Assessed using EMG
arm group label: Patients
arm group type: Experimental
description: Subjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy
intervention type: Procedure
intervention name: Subacromial injection
description: A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.
arm group label: Patients
intervention type: Other
intervention name: Physical Therapy
description: A standardized six-week exercise protocol supervised by a physical therapist
arm group label: Patients
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew R Karduna, PhD
role: Principal Investigator
affiliation: University of Oregon
facility: 
country: United States
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Tendinopathy
mesh term: Muscle Weakness
mesh term: Acute Pain
mesh term: Asthenia
mesh term: Atrophy
sharing ipd: No