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
  Purpose

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.


Condition Intervention Phase
Otitis Media With Effusion
Procedure: osteopathic manipulative medicine (OMM)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by West Virginia School of Osteopathic Medicine:

Primary Outcome Measures:
  • Duration of middle ear effusion following a single episode of acute otitis media [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in tympanogram and acoustic reflectometer readings immediately following one osteopathic manipulative treatment protocol [ Time Frame: immediately following intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Standard Care Only
Subjects will receive standard care only for otitis media from their regular referring physician
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520039

Locations
United States, Maine
University of New England College of Osteopathic Medicine
Biddeford, Maine, United States, 04005
United States, West Virginia
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, United States, 24901
Sponsors and Collaborators
West Virginia School of Osteopathic Medicine
University of New England
American Academy of Osteopathy
Osteopathic Research Center
Investigators
Principal Investigator: Karen M Steele, D.O. West Virginia School of Osteopathic Medicine
  More Information

No publications provided by West Virginia School of Osteopathic Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen M. Steele, DO, Associate Dean for Osteopathic Medical Education, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT00520039     History of Changes
Other Study ID Numbers: KS5172007
Study First Received: August 22, 2007
Last Updated: November 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia School of Osteopathic Medicine:
Otitis Media
Effusion
OMM
OMT
Resolution

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 10, 2014