<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/NCT03232749</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201700603-A</org_study_id>
    <secondary_id>OCR18320</secondary_id>
    <nct_id>NCT03232749</nct_id>
  </id_info>
  <brief_title>Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint</brief_title>
  <official_title>Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effectiveness of a single cortisone injection in patients with&#xD;
      shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors&#xD;
      to help predict how a patient with shoulder osteoarthritis will respond to a cortisone&#xD;
      injection utilizing ultrasound guidance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the effectiveness of intraarticular corticosteroid&#xD;
      injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2)&#xD;
      identifying clinical and radiographic predictors of IACSI success.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The physician in charge is leaving the University of Florida&#xD;
  </why_stopped>
  <start_date type="Actual">April 18, 2018</start_date>
  <completion_date type="Actual">June 6, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</primary_completion_date>
  <phase>Phase 4</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>ASES Scores at Each Time Point</measure>
    <time_frame>Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months</time_frame>
    <description>ASES (American Shoulder &amp; Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale Scores at Each Time Point.</measure>
    <time_frame>Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months</time_frame>
    <description>VAS (Visual Analog Scale) pain score improvement &gt; 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SST (Simple Shoulder Test) Scores at Each Time Point</measure>
    <time_frame>Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months</time_frame>
    <description>SST (Simple Shoulder Test) score improvement &gt; 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Osteoarthritis of the Glenohumeral Joint</condition>
  <arm_group>
    <arm_group_label>symptomatic primary osteoarthritis of the shoulder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intraarticular corticosteroid injections (IACSI)</intervention_name>
    <description>ultrasound-guided IACSI will be administered</description>
    <arm_group_label>symptomatic primary osteoarthritis of the shoulder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>corticosteroid injections</intervention_name>
    <description>Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder</description>
    <arm_group_label>symptomatic primary osteoarthritis of the shoulder</arm_group_label>
    <other_name>Methylprednisolone, Depo-medrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>ultrasound-guided IACSI</description>
    <arm_group_label>symptomatic primary osteoarthritis of the shoulder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will&#xD;
             be recruited from the patient population seeking treatment at the Orthopaedics Sports&#xD;
             Medicine Institute.&#xD;
&#xD;
          -  those who have failed previous treatment including over-the-counter analgesics and&#xD;
             activity modification&#xD;
&#xD;
          -  have elected to receive a medically-indicated, ultrasound-guided IACSI in the&#xD;
             shoulder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from the study for any of the following reasons:&#xD;
&#xD;
          -  Post traumatic osteoarthritis&#xD;
&#xD;
          -  Inflammatory osteoarthritis&#xD;
&#xD;
          -  Imaging confirmed rotator cuff tear&#xD;
&#xD;
          -  Prior ipsilateral shoulder surgery&#xD;
&#xD;
          -  Memory loss or inability to complete study measures&#xD;
&#xD;
          -  History of allergy to injection medications&#xD;
&#xD;
          -  Diabetic patients with patient-reported fasting blood glucose &gt;200&#xD;
&#xD;
          -  Prior injection in the ipsilateral shoulder within three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley Schoch, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF and Shands Orthopaedics and Sports Medicine Institute</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Orthopaedics and Sports Medicine Institute</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>January 27, 2021</results_first_submitted>
  <results_first_submitted_qc>May 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2021</results_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 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>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03232749/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03232749/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Symptomatic Primary Osteoarthritis of the Shoulder</title>
          <description>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder&#xD;
intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered&#xD;
corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder&#xD;
Ultrasound: ultrasound-guided IACSI</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Symptomatic Primary Osteoarthritis of the Shoulder</title>
          <description>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder&#xD;
intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered&#xD;
corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder&#xD;
Ultrasound: ultrasound-guided IACSI</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ASES Scores at Each Time Point</title>
        <description>ASES (American Shoulder &amp; Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).</description>
        <time_frame>Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months</time_frame>
        <population>All participants did not return for all outcome measure time points</population>
        <group_list>
          <group group_id="O1">
            <title>Symptomatic Primary Osteoarthritis of the Shoulder</title>
            <description>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder&#xD;
intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered&#xD;
corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder&#xD;
Ultrasound: ultrasound-guided IACSI</description>
          </group>
        </group_list>
        <measure>
          <title>ASES Scores at Each Time Point</title>
          <description>ASES (American Shoulder &amp; Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).</description>
          <population>All participants did not return for all outcome measure time points</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ASES score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.52" spread="13.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Week ASES score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.72" spread="23.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month ASES scrore</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.86" spread="28.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Month ASES score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.60" spread="28.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month ASES score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.78" spread="22.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month ASES score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.48" spread="25.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale Scores at Each Time Point.</title>
        <description>VAS (Visual Analog Scale) pain score improvement &gt; 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.</description>
        <time_frame>Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months</time_frame>
        <population>All participants did not return for all outcome measure time points</population>
        <group_list>
          <group group_id="O1">
            <title>Symptomatic Primary Osteoarthritis of the Shoulder</title>
            <description>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder&#xD;
intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered&#xD;
corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder&#xD;
Ultrasound: ultrasound-guided IACSI</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale Scores at Each Time Point.</title>
          <description>VAS (Visual Analog Scale) pain score improvement &gt; 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.</description>
          <population>All participants did not return for all outcome measure time points</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline VAS score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.54" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-injection VAS score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.86" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Weeks VAS score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month VAS score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.05" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Month VAS score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" spread="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month VAS score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month VAS score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.44" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>SST (Simple Shoulder Test) Scores at Each Time Point</title>
        <description>SST (Simple Shoulder Test) score improvement &gt; 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)</description>
        <time_frame>Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months</time_frame>
        <population>All participants did not return for all outcome measure time points</population>
        <group_list>
          <group group_id="O1">
            <title>Symptomatic Primary Osteoarthritis of the Shoulder</title>
            <description>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder&#xD;
intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered&#xD;
corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder&#xD;
Ultrasound: ultrasound-guided IACSI</description>
          </group>
        </group_list>
        <measure>
          <title>SST (Simple Shoulder Test) Scores at Each Time Point</title>
          <description>SST (Simple Shoulder Test) score improvement &gt; 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)</description>
          <population>All participants did not return for all outcome measure time points</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline SST Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.29" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Week SST Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.40" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month SST Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.32" spread="3.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Month SST Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.92" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month SST Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" spread="3.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Month SST Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" spread="2.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Symptomatic Primary Osteoarthritis of the Shoulder</title>
          <description>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder&#xD;
intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered&#xD;
corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder&#xD;
Ultrasound: ultrasound-guided IACSI</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>MaryBeth Horodyski, Ed.D., ATC, LAT, FNATA</name_or_title>
      <organization>University of Florida</organization>
      <phone>352-273-7074</phone>
      <email>horodmb@ortho.ufl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03232749
org study id: IRB201700603-A
secondary id: OCR18320
nct id: NCT03232749
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will examine the effectiveness of a single cortisone injection in patients with
      shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors
      to help predict how a patient with shoulder osteoarthritis will respond to a cortisone
      injection utilizing ultrasound guidance.
The purpose of this study is to assess the effectiveness of intraarticular corticosteroid
      injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2)
      identifying clinical and radiographic predictors of IACSI success.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ASES Scores at Each Time Point
time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
description: ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).
measure: Visual Analog Scale Scores at Each Time Point.
time frame: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months
description: VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.
measure: SST (Simple Shoulder Test) Scores at Each Time Point
time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
description: SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)
arm group label: symptomatic primary osteoarthritis of the shoulder
arm group type: Other
description: Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder
intervention type: Procedure
intervention name: intraarticular corticosteroid injections (IACSI)
description: ultrasound-guided IACSI will be administered
arm group label: symptomatic primary osteoarthritis of the shoulder
intervention type: Drug
intervention name: corticosteroid injections
description: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder
arm group label: symptomatic primary osteoarthritis of the shoulder
other name: Methylprednisolone, Depo-medrol
intervention type: Device
intervention name: Ultrasound
description: ultrasound-guided IACSI
arm group label: symptomatic primary osteoarthritis of the shoulder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Bradley Schoch, M.D.
role: Principal Investigator
affiliation: Faculty
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 