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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: standard treament
- 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.
- 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
- acupuncture acceptance [ Time Frame: 3 months ]
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
|Contact: PETER Gilbey, MDemail@example.com|
|Ziv Medical Center||Recruiting|
|Contact: PETER Gilbey, MD|
|Sub-Investigator: YANIV AVRAHAM|
|Principal Investigator:||peter Gilbey, MD||Ziv Medical Center|