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Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study

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ClinicalTrials.gov Identifier: NCT02215681
Recruitment Status : Unknown
Verified July 2014 by Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Device: acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupuncture
acupuncture treatment
Device: acupuncture
No Intervention: standard treament
watchful waiting



Primary Outcome Measures :
  1. presence of inflammatory markers in middle ear effusion [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. acupuncture effect on OME [ Time Frame: 3 months ]
    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


Other Outcome Measures:
  1. acupuncture acceptance [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • otherwise healthy children ages 2-8 years
  • autoscopic OME diagnosis
  • tympanometry type B
  • conductive hearing impairment of 30 decibel or more
  • who are at watchful waiting treatment for 3 months
  • signed parental consent.

Exclusion Criteria:

  • lack of parental consent
  • known coagulopathy
  • past tympanostomy
  • regular intake of steroids or cytotoxic drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215681


Contacts
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Contact: PETER Gilbey, MD 972-4-6828883 peter.g@ziv.health.gov.il

Locations
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Israel
Ziv Medical Center Recruiting
Zefat, Israel
Contact: PETER Gilbey, MD         
Sub-Investigator: YANIV AVRAHAM         
Sponsors and Collaborators
Ziv Hospital
Investigators
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Principal Investigator: peter Gilbey, MD Ziv Medical Center

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Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT02215681     History of Changes
Other Study ID Numbers: 031-13-ziv
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: July 2014
Keywords provided by Ziv Hospital:
otitis media with effusion
acupuncture
inflammatory markers
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases