<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/NCT02242630</url>
  </required_header>
  <id_info>
    <org_study_id>FKE20140023H</org_study_id>
    <nct_id>NCT02242630</nct_id>
  </id_info>
  <brief_title>Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis</brief_title>
  <official_title>Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keesler Air Force Base Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keesler Air Force Base Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is currently unknown whether or not the improvement in pain and function related to a&#xD;
      &quot;steroid shot&quot; for shoulder pain due to subacromial bursitis is important. This study seeks&#xD;
      to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone&#xD;
      significantly affect improvement in shoulder pain 6 weeks after injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Subacromial bursitis is a common site for patients to report shoulder pain. In&#xD;
      some patients it is refractory to conservative therapies such as physical therapy,&#xD;
      acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve&#xD;
      shoulder pain in subacromial bursitis, however, there are few well done clinical trials&#xD;
      guiding which type of corticosteroid and the dose that would be maximally effective and with&#xD;
      the least amount of side effects.&#xD;
&#xD;
      Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but&#xD;
      that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial&#xD;
      which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of&#xD;
      methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be&#xD;
      used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid&#xD;
      injection.&#xD;
&#xD;
      Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder,&#xD;
      the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual&#xD;
      analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in&#xD;
      person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6&#xD;
      weeks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Shoulder Function, as Measured by the QuickDASH ®</measure>
    <time_frame>6 weeks</time_frame>
    <description>The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety</measure>
    <time_frame>6 weeks</time_frame>
    <description>Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Subacromial Bursitis</condition>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Methylprednisolone, 20 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Methylprednisolone, 20 mg, will be injected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methylprednisolone, 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Methylprednisolone, 40 mg, will be injected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triamcinolone, 20 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Triamcinolone, 20 mg, will be injected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triamcinolone, 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Triamcinolone, 40 mg, will be injected</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone, 20 mg</intervention_name>
    <description>Compared with intrabursal triamcinolone</description>
    <arm_group_label>Methylprednisolone, 40 mg</arm_group_label>
    <other_name>Depo-Medrol or Solu-Medrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone, 40 mg</intervention_name>
    <description>Compared with intrabursal triamcinolone</description>
    <arm_group_label>Methylprednisolone, 20 mg</arm_group_label>
    <other_name>Depo-Medrol or Solu-Medrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone, 20 mg</intervention_name>
    <description>Compared with methylprednisolone</description>
    <arm_group_label>Triamcinolone, 40 mg</arm_group_label>
    <other_name>Kenalog</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone, 40 mg</intervention_name>
    <description>Compared with methylprednisolone</description>
    <arm_group_label>Triamcinolone, 20 mg</arm_group_label>
    <other_name>Kenalog</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  History and physical examination consistent with shoulder pain and subacromial&#xD;
             bursitis&#xD;
&#xD;
          -  At least 2 weeks of shoulder pain and subacromial bursitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone&#xD;
&#xD;
          -  History or examination suspicious for a humeral head fracture&#xD;
&#xD;
          -  History or examination consistent with adhesive capsulitis (normal X-Ray of the&#xD;
             shoulder but with less than 100 degrees of active or passive elevation of the arm,&#xD;
             when raising the arm above the head to a maximum with passive external rotation being&#xD;
             50 degrees less than the unaffected side&#xD;
&#xD;
          -  History or examination consistent with acute synovitis of the glenohumeral or&#xD;
             acromioclavicular joint&#xD;
&#xD;
          -  Any shoulder surgery involving the affected arm within the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew B Carroll, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keesler Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keesler Medical Center</name>
      <address>
        <city>Keesler AFB</city>
        <state>Mississippi</state>
        <zip>39534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>August 29, 2016</results_first_submitted>
  <results_first_submitted_qc>October 22, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 14, 2016</results_first_posted>
  <last_update_submitted>October 22, 2016</last_update_submitted>
  <last_update_submitted_qc>October 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subacromial bursitis</keyword>
  <keyword>Triamcinolone</keyword>
  <keyword>Methylprednisolone</keyword>
  <keyword>Shoulder pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Bursitis</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>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to release IPD to other researchers</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects for this study were recruited from the internal medicine (IM) clinic or IM subspecialties clinic from our academic community hospital between September 2014 and December 2015. Subjects had to satisfy the inclusion criteria and have none of the exclusion criteria.</recruitment_details>
      <pre_assignment_details>There was no wash out, run-in, or transitions in this trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Methylprednisolone, 20 mg</title>
          <description>Methylprednisolone, 20 mg, will be injected&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="P2">
          <title>Methylprednisolone, 40 mg</title>
          <description>Methylprednisolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="P3">
          <title>Triamcinolone, 20 mg</title>
          <description>Triamcinolone, 20 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="P4">
          <title>Triamcinolone, 40 mg</title>
          <description>Triamcinolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Fifteen subjects were enrolled in each arm except for the TAC40 arm which had 16. The average age of the cohort was 67.1 ± 10.8 years old.</population>
      <group_list>
        <group group_id="B1">
          <title>Methylprednisolone, 20 mg</title>
          <description>Methylprednisolone, 20 mg, will be injected&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="B2">
          <title>Methylprednisolone, 40 mg</title>
          <description>Methylprednisolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="B3">
          <title>Triamcinolone, 20 mg</title>
          <description>Triamcinolone, 20 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="B4">
          <title>Triamcinolone, 40 mg</title>
          <description>Triamcinolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="16"/>
            <count group_id="B5" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.0" spread="10.9"/>
                    <measurement group_id="B2" value="69.3" spread="10.0"/>
                    <measurement group_id="B3" value="66.9" spread="12.3"/>
                    <measurement group_id="B4" value="69.0" spread="9.5"/>
                    <measurement group_id="B5" value="67.1" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Shoulder Function, as Measured by the QuickDASH ®</title>
        <description>The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methylprednisolone, 20 mg</title>
            <description>Methylprednisolone, 20 mg, will be injected&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
          </group>
          <group group_id="O2">
            <title>Methylprednisolone, 40 mg</title>
            <description>Methylprednisolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
          </group>
          <group group_id="O3">
            <title>Triamcinolone, 20 mg</title>
            <description>Triamcinolone, 20 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
          </group>
          <group group_id="O4">
            <title>Triamcinolone, 40 mg</title>
            <description>Triamcinolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Shoulder Function, as Measured by the QuickDASH ®</title>
          <description>The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="7.1" upper_limit="31.4"/>
                    <measurement group_id="O2" value="21.3" lower_limit="11.3" upper_limit="31.4"/>
                    <measurement group_id="O3" value="19.1" lower_limit="11.8" upper_limit="26.4"/>
                    <measurement group_id="O4" value="24.7" lower_limit="16.4" upper_limit="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale</title>
        <description>Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Methylprednisolone, 20 mg</title>
            <description>Methylprednisolone, 20 mg, will be injected&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
          </group>
          <group group_id="O2">
            <title>Methylprednisolone, 40 mg</title>
            <description>Methylprednisolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
          </group>
          <group group_id="O3">
            <title>Triamcinolone, 20 mg</title>
            <description>Triamcinolone, 20 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
          </group>
          <group group_id="O4">
            <title>Triamcinolone, 40 mg</title>
            <description>Triamcinolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale</title>
          <description>Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.1" upper_limit="1.9"/>
                    <measurement group_id="O2" value="1.8" lower_limit="0.1" upper_limit="3.5"/>
                    <measurement group_id="O3" value="1.9" lower_limit="0.6" upper_limit="3.2"/>
                    <measurement group_id="O4" value="1.8" lower_limit="0.4" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety</title>
        <description>Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.</description>
        <time_frame>6 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data regarding adverse events were collected for the 6 weeks that subjects were followed in this trial, with subjects queried about adverse events at the time of injection, 3 days after injection, 3 weeks, and 6 weeks after injection.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Methylprednisolone, 20 mg</title>
          <description>Methylprednisolone, 20 mg, will be injected&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="E2">
          <title>Methylprednisolone, 40 mg</title>
          <description>Methylprednisolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="E3">
          <title>Triamcinolone, 20 mg</title>
          <description>Triamcinolone, 20 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 40 mg: Compared with methylprednisolone</description>
        </group>
        <group group_id="E4">
          <title>Triamcinolone, 40 mg</title>
          <description>Triamcinolone, 40 mg, will be injected&#xD;
Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone&#xD;
Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone&#xD;
Triamcinolone, 20 mg: Compared with methylprednisolone</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated blood glucose</sub_title>
                <description>Increase in blood glucose as measured by participant which would be considered by the participant as beyond their normal range</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </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>Matthew B. Carroll</name_or_title>
      <organization>Keesler Medical Center</organization>
      <phone>228-376-3629</phone>
      <email>matthew.carroll.1@us.af.mil</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/NCT02242630
org study id: FKE20140023H
nct id: NCT02242630
lead sponsor: 
has dmc: No
It is currently unknown whether or not the improvement in pain and function related to a
      "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks
      to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone
      significantly affect improvement in shoulder pain 6 weeks after injection.
Background: Subacromial bursitis is a common site for patients to report shoulder pain. In
      some patients it is refractory to conservative therapies such as physical therapy,
      acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve
      shoulder pain in subacromial bursitis, however, there are few well done clinical trials
      guiding which type of corticosteroid and the dose that would be maximally effective and with
      the least amount of side effects.

      Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but
      that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial
      which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of
      methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be
      used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid
      injection.

      Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder,
      the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual
      analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in
      person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6
      weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Shoulder Function, as Measured by the QuickDASH ®
time frame: 6 weeks
description: The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)
measure: Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
time frame: 6 weeks
description: Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.
measure: Safety
time frame: 6 weeks
description: Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.
arm group label: Methylprednisolone, 20 mg
arm group type: Active Comparator
description: Methylprednisolone, 20 mg, will be injected
arm group label: Methylprednisolone, 40 mg
arm group type: Active Comparator
description: Methylprednisolone, 40 mg, will be injected
arm group label: Triamcinolone, 20 mg
arm group type: Active Comparator
description: Triamcinolone, 20 mg, will be injected
arm group label: Triamcinolone, 40 mg
arm group type: Active Comparator
description: Triamcinolone, 40 mg, will be injected
intervention type: Drug
intervention name: Methylprednisolone, 20 mg
description: Compared with intrabursal triamcinolone
arm group label: Methylprednisolone, 40 mg
other name: Depo-Medrol or Solu-Medrol
intervention type: Drug
intervention name: Methylprednisolone, 40 mg
description: Compared with intrabursal triamcinolone
arm group label: Methylprednisolone, 20 mg
other name: Depo-Medrol or Solu-Medrol
intervention type: Drug
intervention name: Triamcinolone, 20 mg
description: Compared with methylprednisolone
arm group label: Triamcinolone, 40 mg
other name: Kenalog
intervention type: Drug
intervention name: Triamcinolone, 40 mg
description: Compared with methylprednisolone
arm group label: Triamcinolone, 20 mg
other name: Kenalog
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew B Carroll, MD
role: Principal Investigator
affiliation: Keesler Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Bursitis
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
mesh term: Triamcinolone diacetate
sharing ipd: No
ipd description: No plan to release IPD to other researchers
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 