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

Study Overview
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Brief Summary
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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.

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

Conditions
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Otitis Media With Effusion

Intervention / Treatment
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* Device: acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>acupuncture treatment | Device: acupuncture<br> <br> |
| No Intervention: standard treament<br>watchful waiting | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of inflammatory markers in middle ear effusion | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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otitis media with effusion, acupuncture, inflammatory markers