<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/NCT04420572</url>
  </required_header>
  <id_info>
    <org_study_id>Adem Erbirol</org_study_id>
    <nct_id>NCT04420572</nct_id>
  </id_info>
  <brief_title>Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome</brief_title>
  <official_title>Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Between the large trochanter and the muscles adhering to it, trochanteric bursa and several&#xD;
      other bursa may be found. Trochanteric bursitis can be alone or together with tendinitis of&#xD;
      other bursa and adhering muscles. The first is called trochanteric bursitis, the second is&#xD;
      called hip periarthritis, which is difficult to distinguish clinically. It is more common in&#xD;
      women of middle age. The main complaint is the large trochanter and pain on the side of the&#xD;
      thigh. Pain is aggregated by walking abduction and external rotation by walking, lying down&#xD;
      with hip movements. The palpation is sensitive to the top of the large trochanter. There may&#xD;
      also be tenderness in the muscles in the lateral of the thigh. On plain radiographs, slight&#xD;
      irregularities or peritrocanteric calcifications can be seen in the large trochanter. Bone&#xD;
      scintigraphy shows local increased involvement. In differential diagnosis, stress fractures,&#xD;
      local infection and bone and soft tissue tumors should be considered.&#xD;
&#xD;
      Rest is recommended in treatment. Activities such as running, standing for a long time are&#xD;
      prohibited. Ice application can be given in the acute period. Non-steroidal anti-inflammatory&#xD;
      (SOAI) drugs, analgesics, TENS can be used for pain relief. In cases where conventional&#xD;
      treatments are insufficient, that is, the patient's pain is still continuing and functional&#xD;
      recovery is inadequate, some alternative methods are also applied. These treatments include&#xD;
      ozone, prolotherapy injection applications, dry needling, acupuncture, hirudotherapy,&#xD;
      phytotherapy, mesotherapy, balneotherapy, kinesiobanding, etc. d. In our study, we aim to&#xD;
      compare the effectiveness of ozone injection in patients diagnosed with trochanteric bursitis&#xD;
      and to compare steroid injection with the application of ozone therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 patients with trochanteric bursitis will be taken to the first and second groups by random&#xD;
      number generator method. Ozone therapy is planned for 30 patients in the first group, and&#xD;
      steroid injection is planned for the second group in 30 patients, and the study period is&#xD;
      planned to be 4.5 months. Patients between the ages of 18-75 will be admitted and no&#xD;
      difference will be made in terms of gender. The child will not be sick. Patients will be&#xD;
      evaluated by the doctor who made the injection. All patients will also be evaluated before&#xD;
      the first injection (T0), after treatment (T1) and after the first month (T2) after&#xD;
      treatment. VAS (visual analog scale), Nottingham Health Profile and Harris Hip Evaluation&#xD;
      Form will be used to evaluate patients. Our study is a randomized controlled prospective&#xD;
      study.&#xD;
&#xD;
      Treatment to be applied to patients will be selected randomly. Steroid injections will be&#xD;
      administered to patients in a single dose, while ozone injection will be applied in three&#xD;
      doses (1, 4, 7, 10 days), with a total of 4 doses. In ozone injection applications, while 1st&#xD;
      dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected; 1ml&#xD;
      betamethasone will be used for steroid injection. The evaluation of the patients will be done&#xD;
      by a different physician than the physician who made the injections. The financial burden of&#xD;
      the treatment applied will be borne by the researchers.&#xD;
&#xD;
      This study is a randomized controlled prospective clinical trial. The sample size is 60&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2021</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>double</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>day 0 (before intervention)</time_frame>
    <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>1 week after intervention</time_frame>
    <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>1 month after intervention</time_frame>
    <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>day 0 (before intervention)</time_frame>
    <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>1 week after intervention</time_frame>
    <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>1 month after intervention</time_frame>
    <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Quality of Life - Notthingham Health Profile</measure>
    <time_frame>day 0 (before intervention)</time_frame>
    <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Quality of Life - Notthingham Health Profile</measure>
    <time_frame>1 week after intervention</time_frame>
    <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Quality of Life - Notthingham Health Profile</measure>
    <time_frame>1 month after intervention</time_frame>
    <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Trochanteric Bursitis</condition>
  <arm_group>
    <arm_group_label>ozone injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ozone injection will be applied in three doses (1st, 4th, 7th and 10th days) for a total of 4 doses. In ozone injection applications, 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>steroid injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1ml betamethasone will be used for steroid injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ozone injection</intervention_name>
    <description>ozone injection will be applied in three doses (1st, 4th, 7th and 10th days) for a total of 4 doses. In ozone injection applications, 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected.</description>
    <arm_group_label>ozone injection group</arm_group_label>
    <other_name>no other names</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>betamethasone</intervention_name>
    <description>1ml betamethasone will be used for steroid injection.</description>
    <arm_group_label>steroid injection group</arm_group_label>
    <other_name>no other names</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over 18 years of age, under 75 years of age&#xD;
&#xD;
          2. Lateral hip pain&#xD;
&#xD;
          3. Having pain for at least 3 months&#xD;
&#xD;
          4. The VAS value should be minimum 4 and pain is increased by pressing on t.major.&#xD;
&#xD;
          5. Conservative treatment failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Motor and / or sensory impairment compatible with radiculopathy&#xD;
&#xD;
          2. Connective tissue disease&#xD;
&#xD;
          3. Pregnancy&#xD;
&#xD;
          4. Active infection, immune system disorders, unresolved fractures&#xD;
&#xD;
          5. Hip op history, bursectomy / ilio-tibial band elongation&#xD;
&#xD;
          6. Steroid injection history in the past 4 months&#xD;
&#xD;
          7. Physical therapy history for trochanteric bursitis in the last 4 months&#xD;
&#xD;
          8. Rheumatological patients, pregnancy, Patients with a history of cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ADEM ERBİROL</last_name>
    <role>Study Director</role>
    <affiliation>sultan abdulhamid han</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sultan 2.Abdülhamid Han Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Eyalet/Yerleşke</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <results_first_submitted>August 17, 2021</results_first_submitted>
  <results_first_submitted_qc>October 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 21, 2021</results_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>trochanteric bursitis</keyword>
  <keyword>ozone</keyword>
  <keyword>steroid</keyword>
  <keyword>injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>other researchers would get information from the main researcher. therefore it was not shared.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT04420572/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT04420572/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ozone Injection Group</title>
          <description>The patients in the OI group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study</description>
        </group>
        <group group_id="P2">
          <title>Steroid Injection Group</title>
          <description>A single dose injection was given to the patients in the CSI group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="30"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Ozone Injection Group</title>
          <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
        </group>
        <group group_id="B2">
          <title>Steroid Injection Group</title>
          <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</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="33"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="63"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="49"/>
                  </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="14"/>
                  </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="53.85" spread="11.82"/>
                    <measurement group_id="B2" value="54.87" spread="12.95"/>
                    <measurement group_id="B3" value="54.33" spread="12.28"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.68" spread="4.41"/>
                    <measurement group_id="B2" value="29.64" spread="4.37"/>
                    <measurement group_id="B3" value="29.14" spread="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
        <time_frame>day 0 (before intervention)</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.36" spread="1.06"/>
                    <measurement group_id="O2" value="8.17" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
        <time_frame>1 week after intervention</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.64" spread="2.28"/>
                    <measurement group_id="O2" value="2.93" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity</title>
        <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
        <time_frame>1 month after intervention</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity</title>
          <description>visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.30" spread="3.15"/>
                    <measurement group_id="O2" value="3.00" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functionality</title>
        <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
        <time_frame>day 0 (before intervention)</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Functionality</title>
          <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.03" spread="5.87"/>
                    <measurement group_id="O2" value="53.03" spread="5.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functionality</title>
        <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
        <time_frame>1 week after intervention</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Functionality</title>
          <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.85" spread="12.02"/>
                    <measurement group_id="O2" value="75.00" spread="7.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functionality</title>
        <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
        <time_frame>1 month after intervention</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Functionality</title>
          <description>harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.79" spread="12.58"/>
                    <measurement group_id="O2" value="74.97" spread="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Quality of Life - Notthingham Health Profile</title>
        <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
        <time_frame>day 0 (before intervention)</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Quality of Life - Notthingham Health Profile</title>
          <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261.72" spread="109.77"/>
                    <measurement group_id="O2" value="255.51" spread="127.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Quality of Life - Notthingham Health Profile</title>
        <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
        <time_frame>1 week after intervention</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Quality of Life - Notthingham Health Profile</title>
          <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="215.40" spread="106.58"/>
                    <measurement group_id="O2" value="193.04" spread="103.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Quality of Life - Notthingham Health Profile</title>
        <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
        <time_frame>1 month after intervention</time_frame>
        <population>intent to treat population(all participants)</population>
        <group_list>
          <group group_id="O1">
            <title>Ozone Injection Group</title>
            <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
          </group>
          <group group_id="O2">
            <title>Steroid Injection Group</title>
            <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Quality of Life - Notthingham Health Profile</title>
          <description>Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.&#xD;
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.&#xD;
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status</description>
          <population>intent to treat population(all participants)</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="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210.28" spread="108.58"/>
                    <measurement group_id="O2" value="188.62" spread="109.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>adverse events were not monitored/assessed</time_frame>
      <desc>adverse events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Ozone Injection Group</title>
          <description>The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.</description>
        </group>
        <group group_id="E2">
          <title>Steroid Injection Group</title>
          <description>A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <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>Principal Investigators are NOT 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>Adem Erbirol</name_or_title>
      <organization>SultanAbdulhamid</organization>
      <phone>+905426608788</phone>
      <email>aerbirol@hotmail.com</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/NCT04420572
org study id: Adem Erbirol
nct id: NCT04420572
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Between the large trochanter and the muscles adhering to it, trochanteric bursa and several
      other bursa may be found. Trochanteric bursitis can be alone or together with tendinitis of
      other bursa and adhering muscles. The first is called trochanteric bursitis, the second is
      called hip periarthritis, which is difficult to distinguish clinically. It is more common in
      women of middle age. The main complaint is the large trochanter and pain on the side of the
      thigh. Pain is aggregated by walking abduction and external rotation by walking, lying down
      with hip movements. The palpation is sensitive to the top of the large trochanter. There may
      also be tenderness in the muscles in the lateral of the thigh. On plain radiographs, slight
      irregularities or peritrocanteric calcifications can be seen in the large trochanter. Bone
      scintigraphy shows local increased involvement. In differential diagnosis, stress fractures,
      local infection and bone and soft tissue tumors should be considered.

      Rest is recommended in treatment. Activities such as running, standing for a long time are
      prohibited. Ice application can be given in the acute period. Non-steroidal anti-inflammatory
      (SOAI) drugs, analgesics, TENS can be used for pain relief. In cases where conventional
      treatments are insufficient, that is, the patient's pain is still continuing and functional
      recovery is inadequate, some alternative methods are also applied. These treatments include
      ozone, prolotherapy injection applications, dry needling, acupuncture, hirudotherapy,
      phytotherapy, mesotherapy, balneotherapy, kinesiobanding, etc. d. In our study, we aim to
      compare the effectiveness of ozone injection in patients diagnosed with trochanteric bursitis
      and to compare steroid injection with the application of ozone therapy.
60 patients with trochanteric bursitis will be taken to the first and second groups by random
      number generator method. Ozone therapy is planned for 30 patients in the first group, and
      steroid injection is planned for the second group in 30 patients, and the study period is
      planned to be 4.5 months. Patients between the ages of 18-75 will be admitted and no
      difference will be made in terms of gender. The child will not be sick. Patients will be
      evaluated by the doctor who made the injection. All patients will also be evaluated before
      the first injection (T0), after treatment (T1) and after the first month (T2) after
      treatment. VAS (visual analog scale), Nottingham Health Profile and Harris Hip Evaluation
      Form will be used to evaluate patients. Our study is a randomized controlled prospective
      study.

      Treatment to be applied to patients will be selected randomly. Steroid injections will be
      administered to patients in a single dose, while ozone injection will be applied in three
      doses (1, 4, 7, 10 days), with a total of 4 doses. In ozone injection applications, while 1st
      dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected; 1ml
      betamethasone will be used for steroid injection. The evaluation of the patients will be done
      by a different physician than the physician who made the injections. The financial burden of
      the treatment applied will be borne by the researchers.

      This study is a randomized controlled prospective clinical trial. The sample size is 60
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: double
measure: Pain Severity
time frame: day 0 (before intervention)
description: visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
measure: Pain Severity
time frame: 1 week after intervention
description: visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
measure: Pain Severity
time frame: 1 month after intervention
description: visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
measure: Functionality
time frame: day 0 (before intervention)
description: harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
measure: Functionality
time frame: 1 week after intervention
description: harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
measure: Functionality
time frame: 1 month after intervention
description: harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
measure: Patient Reported Quality of Life - Notthingham Health Profile
time frame: day 0 (before intervention)
description: Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status
measure: Patient Reported Quality of Life - Notthingham Health Profile
time frame: 1 week after intervention
description: Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status
measure: Patient Reported Quality of Life - Notthingham Health Profile
time frame: 1 month after intervention
description: Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.
38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.
Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status
arm group label: ozone injection group
arm group type: Experimental
description: ozone injection will be applied in three doses (1st, 4th, 7th and 10th days) for a total of 4 doses. In ozone injection applications, 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected.
arm group label: steroid injection group
arm group type: Experimental
description: 1ml betamethasone will be used for steroid injection.
intervention type: Drug
intervention name: ozone injection
description: ozone injection will be applied in three doses (1st, 4th, 7th and 10th days) for a total of 4 doses. In ozone injection applications, 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected.
arm group label: ozone injection group
other name: no other names
intervention type: Drug
intervention name: betamethasone
description: 1ml betamethasone will be used for steroid injection.
arm group label: steroid injection group
other name: no other names
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: ADEM ERBİROL
role: Study Director
affiliation: sultan abdulhamid han
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Bursitis
mesh term: Betamethasone
sharing ipd: No
ipd description: other researchers would get information from the main researcher. therefore it was not shared.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 