Otitis Media With Effusion Clinical Trial
Official title:
Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 8 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Ziv Medical Center | Zefat |
Lead Sponsor | Collaborator |
---|---|
Ziv Hospital |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | acupuncture acceptance | 3 months | No | |
Primary | 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 | No |
Secondary | 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 | No |
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