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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Ziv Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Ziv Hospital

Dates:
Date Received: July 9, 2014
Date Started: June 2014
Date Completion: June 2016
Last Updated: August 12, 2014
Last Verified: July 2014