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

NCT ID: NCT02215681

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Otitis Media With Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

acupuncture

acupuncture treatment

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

standard treament

watchful waiting

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

peter Gilbey, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center

Locations

Ziv Medical Center

Safed, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

PETER Gilbey, MD

Role: CONTACT

peter.g@ziv.health.gov.il

972-4-6828883

Facility Contacts

PETER Gilbey, MD

Role: primary

Other Identifiers

031-13-ziv

Identifier Type: -

Identifier Source: org_study_id