Osteopathic Otitis Media Research Study
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 2 |
| Updated: | 4/17/2018 |
| Start Date: | September 2007 |
| End Date: | August 2009 |
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.
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.
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.
Inclusion Criteria:
- 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
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
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2
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