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

August 12, 2014 updated by: Ziv Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Zefat, Israel
        • Recruiting
        • Ziv Medical Center
        • Sub-Investigator:
          • YANIV AVRAHAM
        • Contact:
          • PETER Gilbey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Other Outcome Measures

Outcome Measure
Time Frame
acupuncture acceptance
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Investigators

  • Principal Investigator: peter Gilbey, MD, Ziv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 031-13-ziv

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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