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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02215681

Enrollment

100

Registered

2014-08-13

Start date

2014-06-30

Completion date

2016-06-30

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media With Effusion

Keywords

otitis media with effusion, acupuncture, inflammatory markers

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.

Interventions

DEVICEacupuncture

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 8 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
presence of inflammatory markers in middle ear effusion	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

Measure	Time frame	Description
acupuncture effect on OME	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

Other

Measure	Time frame
acupuncture acceptance	3 months

Countries

Israel

Contacts

Primary ContactPETER Gilbey, MD

peter.g@ziv.health.gov.il972-4-6828883

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026