Osteopathic Otitis Media Research Study (OOMRS)

This study has been completed.
Sponsor:
Collaborators:
University of New England
American Academy of Osteopathy
Osteopathic Research Center
Information provided by:
West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT00520039
First received: August 22, 2007
Last updated: November 18, 2009
Last verified: November 2009

August 22, 2007
November 18, 2009
September 2007
August 2009   (final data collection date for primary outcome measure)
Duration of middle ear effusion following a single episode of acute otitis media [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00520039 on ClinicalTrials.gov Archive Site
Changes in tympanogram and acoustic reflectometer readings immediately following one osteopathic manipulative treatment protocol [ Time Frame: immediately following intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Osteopathic Otitis Media Research Study
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

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.

Acute otitis media is a significant world wide problem commonly affecting children between 6 and 18 months, and is the most frequent reason for childhood illness visits to a physician in the US. By three years of age, 50-70% of children will have had one episode, while one-third will have had more than three. Persistence of middle ear effusion following an episode of acute otitis media is thought to predispose the child to recurrent infection. The standard care for recurrent acute otitis media includes long term antibiotic prophylaxis and surgery. The risks of standard care are recognized, and alternative means of treating acute disease and preventing recurrent otitis media are needed.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Otitis Media With Effusion
Procedure: 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.
  • Experimental: 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.
    Intervention: Procedure: osteopathic manipulative medicine (OMM)
  • No Intervention: Standard Care Only
    Subjects will receive standard care only for otitis media from their regular referring physician
    Intervention: Procedure: osteopathic manipulative medicine (OMM)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 6 months up to 2 years
  • Documented presence of acute otitis media following the 2004 AAP/AAFP Guidelines within 3 days of entry into the study

Exclusion Criteria:

  • 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
Both
6 Months to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00520039
KS5172007
Yes
Karen M. Steele, DO, Associate Dean for Osteopathic Medical Education, West Virginia School of Osteopathic Medicine
West Virginia School of Osteopathic Medicine
  • University of New England
  • American Academy of Osteopathy
  • Osteopathic Research Center
Principal Investigator: Karen M Steele, D.O. West Virginia School of Osteopathic Medicine
West Virginia School of Osteopathic Medicine
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP