Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
Primary Purpose
Otitis Media With Effusion
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion focused on measuring otitis media with effusion, acupuncture, inflammatory markers
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
Sites / Locations
- Ziv Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
acupuncture
standard treament
Arm Description
acupuncture treatment
watchful waiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02215681
Brief Title
Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
Official Title
Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion
Keywords
otitis media with effusion, acupuncture, inflammatory markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture
Arm Type
Experimental
Arm Description
acupuncture treatment
Arm Title
standard treament
Arm Type
No Intervention
Arm Description
watchful waiting
Intervention Type
Device
Intervention Name(s)
acupuncture
Primary Outcome Measure Information:
Title
presence of inflammatory markers in middle ear effusion
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
acupuncture effect on OME
Description
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
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
acupuncture acceptance
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PETER Gilbey, MD
Phone
972-4-6828883
Email
peter.g@ziv.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
peter Gilbey, MD
Organizational Affiliation
Ziv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziv Medical Center
City
Zefat
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PETER Gilbey, MD
First Name & Middle Initial & Last Name & Degree
YANIV AVRAHAM
12. IPD Sharing Statement
Learn more about this trial
Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study
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