Osteopathic Otitis Media Research Study (OOMRS)
|Otitis Media With Effusion||Procedure: osteopathic manipulative medicine (OMM)||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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|
- Duration of middle ear effusion following a single episode of acute otitis media [ Time Frame: 1 month ]
- Changes in tympanogram and acoustic reflectometer readings immediately following one osteopathic manipulative treatment protocol [ Time Frame: immediately following intervention ]
|Study Start Date:||September 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520039
|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|
|Principal Investigator:||Karen M Steele, D.O.||West Virginia School of Osteopathic Medicine|