Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2007-09-30
2009-08-31
Brief Summary
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Detailed Description
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For over a century, osteopathic physicians have reported favorable clinical outcomes in children treated with osteopathic manipulative medicine (OMM) in addition to standard medical care. To determine if a standardized OMM protocol will reduce the duration of middle ear effusion (MEE) after onset of acute otitis media, we outline a prospective, randomized, blinded, multi-center efficacy study of children ages six months to two years with a single episode of acute otitis media. Subjects will be randomized into one of two treatment groups: standard care plus OMM and standard care only. Subjects will be followed for one month to determine rate of resolution of middle ear effusion following onset of the acute otitis media. Statistical analysis will determine any differences between subjects in the two treatment groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard Care Plus OMM
Subjects 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.
osteopathic manipulative medicine (OMM)
At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
Standard Care Only
Subjects will receive standard care only for otitis media from their regular referring physician
No interventions assigned to this group
Interventions
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osteopathic manipulative medicine (OMM)
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
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Inclusion Criteria
* Documented presence of acute otitis media following the 2004 AAP/AAFP Guidelines within 3 days of entry into the study
Exclusion Criteria
* 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
6 Months
2 Years
ALL
No
Sponsors
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University of New England
OTHER
American Academy of Osteopathy
OTHER
Osteopathic Research Center
UNKNOWN
West Virginia School of Osteopathic Medicine
OTHER
Responsible Party
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Karen M. Steele, D.O., FAAO
Professor Emerita
Principal Investigators
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Karen M Steele, D.O.
Role: PRINCIPAL_INVESTIGATOR
West Virginia School of Osteopathic Medicine
Locations
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University of New England College of Osteopathic Medicine
Biddeford, Maine, United States
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, United States
Countries
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References
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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.
Steele 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.
Other Identifiers
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KS5172007
Identifier Type: -
Identifier Source: org_study_id
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