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

Ziv Hospital

Status: Unknown

Conditions: Otitis Media With Effusion

Treatments: Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02215681

031-13-ziv

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

acupuncture

Experimental group

Description:

acupuncture treatment

Treatment:

Device: acupuncture

standard treament

No Intervention group

Description:

watchful waiting