<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/NCT02221817</url>
  </required_header>
  <id_info>
    <org_study_id>1407358564</org_study_id>
    <nct_id>NCT02221817</nct_id>
  </id_info>
  <brief_title>Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis</brief_title>
  <official_title>Prospective, Randomized Trial of Ultrasound Guided and Blind Corticosteroid Injection for Trochanteric Bursitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with&#xD;
      trochanteric bursitis experience chronic intermittent or continuous hip pain at and around&#xD;
      the greater trochanter.&#xD;
&#xD;
      The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa,&#xD;
      though this has not been confirmed. Accordingly, the use of corticosteroid injections has&#xD;
      been shown to provide considerable relief. However, routine &quot;blind&quot; injections, those&#xD;
      performed without the aid of imaging, such as fluoroscopy, have shown limited success in the&#xD;
      appropriate needle placement. Fortunately, blind injections have yielded positive results in&#xD;
      majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical&#xD;
      outcome for trochanter bursa injections.&#xD;
&#xD;
      Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such&#xD;
      as ultrasound have not been studied and may be more useful. Fluoroscopy allows for&#xD;
      bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue&#xD;
      structures such as the bursa and has gained significant support for use in musculoskeletal&#xD;
      injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an&#xD;
      ultrasound guided injection and whether ultrasound should be routinely used during trochanter&#xD;
      bursa injections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Pain Intensity Measured on Visual Analog Scale (VAS)</measure>
    <time_frame>3 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disability Measured on Becks Disability Scale</measure>
    <time_frame>Baseline, 2 weeks, 3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Effects</measure>
    <time_frame>2 weeks, 3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Improvement</measure>
    <time_frame>2 weeks, 3 months</time_frame>
    <description>Percent improvement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Bursitis</condition>
  <arm_group>
    <arm_group_label>Blind</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trochanter injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trochanter injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trochanter bursa injections</intervention_name>
    <arm_group_label>Blind</arm_group_label>
    <arm_group_label>Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of trochanteric bursitis&#xD;
&#xD;
          2. 18 years of age or older when written informed consent is obtained&#xD;
&#xD;
          3. Signed Institutional Review Board (IRB) approved informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to triamcinolone or bupivicaine&#xD;
&#xD;
          2. Coagulopathy&#xD;
&#xD;
          3. Active Infection&#xD;
&#xD;
          4. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that&#xD;
             would limit study candidate's ability to assess pain relief or complete study&#xD;
             assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West Virginia University Hospitals</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>December 22, 2020</results_first_submitted>
  <results_first_submitted_qc>December 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 20, 2021</results_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 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>Bursitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was ended and the PI has left the institution. The numbers presented are what was initially entered by the research team. From data available, 80 participants were enrolled on the study; no information about those participants could be located. No other data could be located and it cannot be determined which arm the 80 participants were enrolled in or if they completed the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Blind</title>
          <description>Trochanter injection&#xD;
Trochanter bursa injections</description>
        </group>
        <group group_id="P2">
          <title>Ultrasound</title>
          <description>Trochanter injection&#xD;
Trochanter bursa injections&#xD;
Ultrasound</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
      <group_list>
        <group group_id="B1">
          <title>Blind</title>
          <description>Trochanter injection&#xD;
Trochanter bursa injections</description>
        </group>
        <group group_id="B2">
          <title>Ultrasound</title>
          <description>Trochanter injection&#xD;
Trochanter bursa injections&#xD;
Ultrasound</description>
        </group>
        <group group_id="B3">
          <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="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </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>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Intensity Measured on Visual Analog Scale (VAS)</title>
        <time_frame>3 month</time_frame>
        <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Blind</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity Measured on Visual Analog Scale (VAS)</title>
          <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability Measured on Becks Disability Scale</title>
        <time_frame>Baseline, 2 weeks, 3 month</time_frame>
        <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Blind</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Disability Measured on Becks Disability Scale</title>
          <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Effects</title>
        <time_frame>2 weeks, 3 month</time_frame>
        <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Blind</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Effects</title>
          <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Improvement</title>
        <description>Percent improvement</description>
        <time_frame>2 weeks, 3 months</time_frame>
        <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
        <group_list>
          <group group_id="O1">
            <title>Blind</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound</title>
            <description>Trochanter injection&#xD;
Trochanter bursa injections&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Improvement</title>
          <description>Percent improvement</description>
          <population>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Blind</title>
          <description>Trochanter injection&#xD;
Trochanter bursa injections</description>
        </group>
        <group group_id="E2">
          <title>Ultrasound</title>
          <description>Trochanter injection&#xD;
Trochanter bursa injections&#xD;
Ultrasound</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <limitations_and_caveats>This study is considered to be completed, because before leaving the institution the PI indicated the study status as completed and entered that actual enrollment number of 80 participants. No other information could be located or obtained for the study and therefore no specific results information can be included. The study status as completed and actual enrollment number of 80 participants should be considered an accurate representation of all available study information.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trials Compliance Coordinator</name_or_title>
      <organization>West Virginia Universtiy, WVCTSI</organization>
      <phone>304-293-0216</phone>
      <email>ctgovadmin@hsc.wvu.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/NCT02221817
org study id: 1407358564
nct id: NCT02221817
lead sponsor: 
has dmc: No
Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with
      trochanteric bursitis experience chronic intermittent or continuous hip pain at and around
      the greater trochanter.

      The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa,
      though this has not been confirmed. Accordingly, the use of corticosteroid injections has
      been shown to provide considerable relief. However, routine "blind" injections, those
      performed without the aid of imaging, such as fluoroscopy, have shown limited success in the
      appropriate needle placement. Fortunately, blind injections have yielded positive results in
      majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical
      outcome for trochanter bursa injections.

      Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such
      as ultrasound have not been studied and may be more useful. Fluoroscopy allows for
      bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue
      structures such as the bursa and has gained significant support for use in musculoskeletal
      injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an
      ultrasound guided injection and whether ultrasound should be routinely used during trochanter
      bursa injections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain Intensity Measured on Visual Analog Scale (VAS)
time frame: 3 month
measure: Disability Measured on Becks Disability Scale
time frame: Baseline, 2 weeks, 3 month
measure: Adverse Effects
time frame: 2 weeks, 3 month
measure: Pain Improvement
time frame: 2 weeks, 3 months
description: Percent improvement
arm group label: Blind
arm group type: Active Comparator
description: Trochanter injection
arm group label: Ultrasound
arm group type: Experimental
description: Trochanter injection
intervention type: Procedure
intervention name: Trochanter bursa injections
arm group label: Blind
arm group label: Ultrasound
intervention type: Device
intervention name: Ultrasound
arm group label: Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bursitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study is considered to be completed, because before leaving the institution the PI indicated the study status as completed and entered that actual enrollment number of 80 participants. No other information could be located or obtained for the study and therefore no specific results information can be included. The study status as completed and actual enrollment number of 80 participants should be considered an accurate representation of all available study information.
point of contact: 