xml: <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/NCT06041230</url>
    </required_header>
    <id_info>
      <org_study_id>E2-23-3838</org_study_id>
      <nct_id>NCT06041230</nct_id>
    </id_info>
    <brief_title>Comparison of the Efficiency of ESWT and Ozone Injection in Patients With Chronic Plantar Fasciitis</brief_title>
    <official_title>Comparison of the Efficiency of Extracorporeal Shock Wave Therapy and Ultrasound-Guided Ozone Injection in Patients With Chronic Plantar Fasciitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara City Hospital Bilkent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara City Hospital Bilkent</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Extracorporeal Shock Wave Therapy (ESWT) is a conservative treatment method that has been&#xD;
        widely used in musculoskeletal diseases in recent years. Its mechanism is to provide&#xD;
        hyperstimulation and vascularity increase with the help of acoustic waves focused on a&#xD;
        specific area, thus accelerating healing and reducing pain. This method, which is frequently&#xD;
        used in plantar fasciitis, is frequently applied to patients whose symptoms persist despite&#xD;
        first-line treatment strategies.&#xD;
  &#xD;
        Ozone injections have been frequently used in musculoskeletal disorders in recent years and&#xD;
        are mainly used in osteoarthritis, osteomyelitis, tendon, fascia and ligament injuries,&#xD;
        vertebra and disc pathologies and neuropathic pain. Analgesic effect on musculoskeletal&#xD;
        system (release of endorphins, activation of antinociceptive system, reduction of edema)&#xD;
        anti-inflammatory effect (regulation of cytokine release, reduction of superoxide radicals,&#xD;
        modulation of prostaglandin), regulation of local oxygenation and circulation, tissue repair&#xD;
        (neutralization of preteolytic enzymes, fibroblast proliferation) and has an antimicrobial&#xD;
        effect. Although it is also used in the treatment of plantar fasciitis, there are limited&#xD;
        articles on this subject in the literature.&#xD;
  &#xD;
        In our study, it was aimed to compare the effectiveness of ESWT and ozone injection therapy,&#xD;
        which are two treatment strategies with regenerative action mechanisms, in patients with&#xD;
        resistant plantar fasciitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 12, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</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 (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>pre-treatment, immediately post-treatment and three months follow-up</time_frame>
      <description>measurement for pain severity, It is a value between 0-100. &quot;0&quot; means no pain and &quot;100&quot; means maximum pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>plantar fascia thickness</measure>
      <time_frame>pre-treatment, immediately post-treatment and three months follow-up</time_frame>
      <description>sonographic measurement for plantar fascia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Foot Function İndex</measure>
      <time_frame>pre-treatment, immediately post-treatment and three months follow-up</time_frame>
      <description>measurements for foot function. An increase in the value indicates worse foot functions.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Plantar Fascitis</condition>
    <arm_group>
      <arm_group_label>Ultrasound guided ozone injection therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Extracorporeal shock wave therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ozone Generator</intervention_name>
      <description>Ultrasound guided ozone therapy</description>
      <arm_group_label>Ultrasound guided ozone injection therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Extracorporeal shock wave therapy device</intervention_name>
      <description>Extracorporeal shock wave therapy device</description>
      <arm_group_label>Extracorporeal shock wave therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be over 18 years old&#xD;
  &#xD;
            -  Heel pain lasting longer than 3 months&#xD;
  &#xD;
            -  Localized pain and tenderness on palpation on the medial aspect of the calcaneal&#xD;
               tuberosity when the ankle is fully dorsiflexed.&#xD;
  &#xD;
            -  In the first step of walking, &gt;50 mm according to VAS. and description of pain&#xD;
  &#xD;
            -  Presence of plantar fasciitis typical findings on ultrasonography (thickening more&#xD;
               than 4 mm in the proximal plantar fascia with changes in fibril pattern)&#xD;
  &#xD;
            -  Failure to respond to conservative treatment before (nonsteroidal anti-inflammatory&#xD;
               drugs, stretching, heel cushion, shoe modifications, orthotics, cold, heat, taping,&#xD;
               massage)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  being under the age of 18&#xD;
  &#xD;
            -  Any skin lesions in the heel area&#xD;
  &#xD;
            -  Inflammatory, rheumatic arthritis&#xD;
  &#xD;
            -  Having a history of fracture, trauma or operation in the heel area&#xD;
  &#xD;
            -  Systemic infection or malignancy&#xD;
  &#xD;
            -  Having a pacemaker&#xD;
  &#xD;
            -  Local injection to the heel area in the last 6 months or use of topical or oral&#xD;
               nonsteroidal anti-inflammatory drugs in the last 2 weeks&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Berke Aras, Ass. Professor</last_name>
      <phone>+905365851518</phone>
      <email>drberkearas@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ankara Bilkent City Hospital</name>
        <address>
          <city>Ankara</city>
          <zip>06100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Berke Aras, Associate Professor</last_name>
        <phone>+905365851518</phone>
        <email>drberkearas@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
      <investigator_full_name>Berke Aras</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>ozone therapy</keyword>
    <keyword>ESWT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fasciitis</mesh_term>
      <mesh_term>Fasciitis, Plantar</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041230
  org study id: E2-23-3838
  nct id: NCT06041230
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Extracorporeal Shock Wave Therapy (ESWT) is a conservative treatment method that has been
        widely used in musculoskeletal diseases in recent years. Its mechanism is to provide
        hyperstimulation and vascularity increase with the help of acoustic waves focused on a
        specific area, thus accelerating healing and reducing pain. This method, which is frequently
        used in plantar fasciitis, is frequently applied to patients whose symptoms persist despite
        first-line treatment strategies.
  
        Ozone injections have been frequently used in musculoskeletal disorders in recent years and
        are mainly used in osteoarthritis, osteomyelitis, tendon, fascia and ligament injuries,
        vertebra and disc pathologies and neuropathic pain. Analgesic effect on musculoskeletal
        system (release of endorphins, activation of antinociceptive system, reduction of edema)
        anti-inflammatory effect (regulation of cytokine release, reduction of superoxide radicals,
        modulation of prostaglandin), regulation of local oxygenation and circulation, tissue repair
        (neutralization of preteolytic enzymes, fibroblast proliferation) and has an antimicrobial
        effect. Although it is also used in the treatment of plantar fasciitis, there are limited
        articles on this subject in the literature.
  
        In our study, it was aimed to compare the effectiveness of ESWT and ozone injection therapy,
        which are two treatment strategies with regenerative action mechanisms, in patients with
        resistant plantar fasciitis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Visual Analog Scale
  time frame: pre-treatment, immediately post-treatment and three months follow-up
  description: measurement for pain severity, It is a value between 0-100. "0" means no pain and "100" means maximum pain.
  measure: plantar fascia thickness
  time frame: pre-treatment, immediately post-treatment and three months follow-up
  description: sonographic measurement for plantar fascia
  measure: Foot Function İndex
  time frame: pre-treatment, immediately post-treatment and three months follow-up
  description: measurements for foot function. An increase in the value indicates worse foot functions.
  arm group label: Ultrasound guided ozone injection therapy
  arm group type: Active Comparator
  arm group label: Extracorporeal shock wave therapy
  arm group type: Active Comparator
  intervention type: Device
  intervention name: Ozone Generator
  description: Ultrasound guided ozone therapy
  arm group label: Ultrasound guided ozone injection therapy
  intervention type: Device
  intervention name: Extracorporeal shock wave therapy device
  description: Extracorporeal shock wave therapy device
  arm group label: Extracorporeal shock wave therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Berke Aras, Ass. Professor
  phone: +905365851518
  email: drberkearas@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ankara City Hospital Bilkent
  investigator full name: Berke Aras
  investigator title: Associate Professor
  mesh term: Fasciitis
  mesh term: Fasciitis, Plantar
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)