Osteopathic Otitis Media Research Study
OOMRS
Effect of Osteopathic Manipulative Medicine (OMM) on the Duration of Middle Ear Effusion in Children Following Diagnosis of Acute Otitis Media, as Measured by Tympanograms and Acoustic Reflectometry
1 other identifier
interventional
52
1 country
2
Brief Summary
The purpose of this study is to determine if the application of osteopathic manipulative medicine speeds the rate of resolution of middle ear effusion (fluid) in children following an episode of acute otitis media.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2007
Typical duration for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
August 22, 2007
CompletedFirst Posted
Study publicly available on registry
August 23, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
March 26, 2018
CompletedMarch 26, 2018
August 1, 2017
1.9 years
August 22, 2007
November 10, 2016
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
For this study, the tympanogram was chosen to measure middle ear effusion. Three tympanogram readings from each ear included in the study were taken at the beginning of each of 5 Study Visits. For the intervention group, a second set of 3 tympanograms was taken immediately after the OMM on Visits 1, 2 and 3. All tympanograms were sent to a blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. "A" and "C1" readings were considered "normal" and "B" and "C2" readings were considered "abnormal". The extent to which the tympanogram readings of each ear included in the study changed from baseline over 4 weeks was computed by crosstabulating the intervention group by the normal/abnormal changes in tympanograms.
1 month
Secondary Outcomes (2)
Change in Middle Ear Effusion Immediately After OMM at Study Visit 2
Before and immediately after OMM at study visit 2
Change in Middle Ear Effusion Immediately After OMM at Study Visit 3
Before and immediately after OMM at study visit 3
Study Arms (2)
Standard Care Plus OMM
EXPERIMENTALSubjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate. Subjects will also receive standard care for otitis media from their referring physician.
Standard Care Only
NO INTERVENTIONSubjects will receive standard care only for otitis media from their regular referring physician
Interventions
At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
Eligibility Criteria
You may qualify if:
- Age 6 months up to second birthday
- Documented presence of acute otitis media following the 2004 AAP/AAFP Guidelines within 3 days of entry into the study
You may not qualify if:
- Chromosomal abnormalities
- Major congenital malformations of the head and neck, including torticollis
- Immunologic abnormalities or deficiencies
- Any prior ear-nose-throat surgery performed as a treatment for otitis media
- Any tube placement surgery scheduled during the four weeks of the study.
- Normal tympanograms at entry into study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West Virginia School of Osteopathic Medicinelead
- University of New Englandcollaborator
- American Academy of Osteopathycollaborator
- Osteopathic Research Centercollaborator
Study Sites (2)
University of New England College of Osteopathic Medicine
Biddeford, Maine, 04005, United States
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, 24901, United States
Related Publications (2)
Steele KM, Carreiro JE, Viola JH, Conte JA, Ridpath LC. Effect of osteopathic manipulative treatment on middle ear effusion following acute otitis media in young children: a pilot study. J Am Osteopath Assoc. 2014 Jun;114(6):436-47. doi: 10.7556/jaoa.2014.094.
PMID: 24917631DERIVEDSteele KM, Viola J, Burns E, Carreiro JE. Brief report of a clinical trial on the duration of middle ear effusion in young children using a standardized osteopathic manipulative medicine protocol. J Am Osteopath Assoc. 2010 May;110(5):278-84.
PMID: 20538749DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
One site closed after year 1 due to lower than expected subject recruitment. Lower than expected recruitment overall.
Results Point of Contact
- Title
- Dr. Karen Steele
- Organization
- West Virginia School of Osteopathic Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Karen M Steele, D.O.
West Virginia School of Osteopathic Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Emerita
Study Record Dates
First Submitted
August 22, 2007
First Posted
August 23, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
March 26, 2018
Results First Posted
March 26, 2018
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share