Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 9, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 13, 2014
July 1, 2014
2 years
July 9, 2014
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
acupuncture effect on OME
3 months
Other Outcomes (1)
acupuncture acceptance
3 months
Study Arms (2)
acupuncture
EXPERIMENTALacupuncture treatment
standard treament
NO INTERVENTIONwatchful waiting
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- lack of parental consent
- known coagulopathy
- past tympanostomy
- regular intake of steroids or cytotoxic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziv Hospitallead
Study Sites (1)
Ziv Medical Center
Safed, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
peter Gilbey, MD
Ziv Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2014
First Posted
August 13, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 13, 2014
Record last verified: 2014-07