<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/NCT02215681</url>
  </required_header>
  <id_info>
    <org_study_id>031-13-ziv</org_study_id>
    <nct_id>NCT02215681</nct_id>
  </id_info>
  <brief_title>Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study</brief_title>
  <official_title>Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziv Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media&#xD;
      with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are&#xD;
      in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control.&#xD;
      50 Children in the acupuncture group will receive standard treatment combined with&#xD;
      acupuncture for 3 months. 50 Children in the control group will receive standard treatment&#xD;
      only, for the same time period. After 3 months, both groups will be reassessed for OME.&#xD;
      Children with no improvement from both groups will be assigned for tympanostomy.&#xD;
&#xD;
      Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be&#xD;
      collected, analyzed and evaluated for group differences.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>presence of inflammatory markers in middle ear effusion</measure>
    <time_frame>3 months</time_frame>
    <description>after 3 months, patients in both groups will be reevaluated for OME by micro otoscopy and tympanometry, including an audiogram. patients with no improvement, will be submitted for tympanostomy in accordance with standard criteria. middle ear effusion will be collected and analysed by ELISA for viral/bacterial RNA presence and flow cytometry for leukocyte presence. results will be statistically processed for between group differences.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acupuncture effect on OME</measure>
    <time_frame>3 months</time_frame>
    <description>after 3 months, patients from both group will undergo micro otoscopy,tympanometry and an audiogram to evaluate OME presence. group differences will be statistically processed</description>
  </secondary_outcome>
  <other_outcome>
    <measure>acupuncture acceptance</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Otitis Media With Effusion</condition>
  <arm_group>
    <arm_group_label>acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>acupuncture treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard treament</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>watchful waiting</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <arm_group_label>acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  otherwise healthy children ages 2-8 years&#xD;
&#xD;
          -  autoscopic OME diagnosis&#xD;
&#xD;
          -  tympanometry type B&#xD;
&#xD;
          -  conductive hearing impairment of 30 decibel or more&#xD;
&#xD;
          -  who are at watchful waiting treatment for 3 months&#xD;
&#xD;
          -  signed parental consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of parental consent&#xD;
&#xD;
          -  known coagulopathy&#xD;
&#xD;
          -  past tympanostomy&#xD;
&#xD;
          -  regular intake of steroids or cytotoxic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>peter Gilbey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ziv Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>PETER Gilbey, MD</last_name>
    <phone>972-4-6828883</phone>
    <email>peter.g@ziv.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ziv Medical Center</name>
      <address>
        <city>Zefat</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>PETER Gilbey, MD</last_name>
    </contact>
    <investigator>
      <last_name>YANIV AVRAHAM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>otitis media with effusion</keyword>
  <keyword>acupuncture</keyword>
  <keyword>inflammatory markers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Otitis</mesh_term>
    <mesh_term>Otitis Media</mesh_term>
    <mesh_term>Otitis Media with Effusion</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02215681
org study id: 031-13-ziv
nct id: NCT02215681
lead sponsor: 
has dmc: No
Objective: to evaluate acupunctures effect on inflammatory markers in pediatric Otitis Media
      with Effusion Methods: 100 Children with otitis media with effusion (OME) diagnosis, who are
      in watchful waiting for 3 month, will be randomized in two groups: acupuncture and control.
      50 Children in the acupuncture group will receive standard treatment combined with
      acupuncture for 3 months. 50 Children in the control group will receive standard treatment
      only, for the same time period. After 3 months, both groups will be reassessed for OME.
      Children with no improvement from both groups will be assigned for tympanostomy.

      Data collection: in children undergoing tympanostomy, middle ear effusion (MEE) will be
      collected, analyzed and evaluated for group differences.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: presence of inflammatory markers in middle ear effusion
time frame: 3 months
description: after 3 months, patients in both groups will be reevaluated for OME by micro otoscopy and tympanometry, including an audiogram. patients with no improvement, will be submitted for tympanostomy in accordance with standard criteria. middle ear effusion will be collected and analysed by ELISA for viral/bacterial RNA presence and flow cytometry for leukocyte presence. results will be statistically processed for between group differences.
measure: acupuncture effect on OME
time frame: 3 months
description: after 3 months, patients from both group will undergo micro otoscopy,tympanometry and an audiogram to evaluate OME presence. group differences will be statistically processed
measure: acupuncture acceptance
time frame: 3 months
arm group label: acupuncture
arm group type: Experimental
description: acupuncture treatment
arm group label: standard treament
arm group type: No Intervention
description: watchful waiting
intervention type: Device
intervention name: acupuncture
arm group label: acupuncture
criteria: 
gender: All
minimum age: 2 Years
maximum age: 8 Years
healthy volunteers: No
last name: peter Gilbey, MD
role: Principal Investigator
affiliation: Ziv Medical Center
last name: PETER Gilbey, MD
phone: 972-4-6828883
email: peter.g@ziv.health.gov.il
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Otitis
mesh term: Otitis Media
mesh term: Otitis Media with Effusion