Osteopathic Otitis Media Research Study (OOMRS)

West Virginia School of Osteopathic Medicine

Status: Completed

Conditions: Otitis Media With Effusion

Treatments: Procedure: osteopathic manipulative medicine (OMM)

Study type: Interventional

Funder types: Other

Identifiers

NCT00520039

KS5172007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 6 months to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Standard Care Plus OMM

Experimental group

Description:

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.

Treatment:

Procedure: osteopathic manipulative medicine (OMM)

Standard Care Only

No Intervention group

Description:

Subjects will receive standard care only for otitis media from their regular referring physician