Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- presence of inflammatory markers in middle ear effusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
acupuncture
acupuncture treatment
Intervention: acupuncture (Device)
standard treament
watchful waiting
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- acupuncture effect on OME(3 months)