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

Otitis Media With Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02215681
• Other study ID #: 031-13-ziv
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2014
• Last updated: August 12, 2014
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2014
• Source: Ziv Hospital
• Contact: PETER Gilbey, MD
• Phone: 972-4-6828883
• Email: peter.g[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Device:
• acupuncture

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

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