Clinical trial NCT00520039: Osteopathic Otitis Media Research Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media With Effusion
Keywords: Otitis Media
Effusion
OMM
OMT
Resolution
Lead sponsor: West Virginia School of Osteopathic Medicine
Sponsor class: OTHER
Collaborators: name: University of New England
name: American Academy of Osteopathy
name: Osteopathic Research Center
First posted: 2007-08-23
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
timeFrame: 1 month
Secondary outcomes:
measure: Change in Middle Ear Effusion Immediately After OMM at Study Visit 2
timeFrame: Before and immediately after OMM at study visit 2
measure: Change in Middle Ear Effusion Immediately After OMM at Study Visit 3
timeFrame: Before and immediately after OMM at study visit 3
Other outcomes:
Locations:
city: Biddeford
country: United States
facility: University of New England College of Osteopathic Medicine
state: Maine
city: Lewisburg
country: United States
facility: West Virginia School of Osteopathic Medicine
state: West Virginia
Study officials:
affiliation: West Virginia School of Osteopathic Medicine
name: Karen M Steele, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steele KM, Carreiro JE, Viola JH, Conte JA, Ridpath LC. Effect of osteopathic manipulative treatment on middle ear effusion following acute otitis media in young children: a pilot study. J Am Osteopath Assoc. 2014 Jun;114(6):436-47. doi: 10.7556/jaoa.2014.094.
citation: Steele KM, Viola J, Burns E, Carreiro JE. Brief report of a clinical trial on the duration of middle ear effusion in young children using a standardized osteopathic manipulative medicine protocol. J Am Osteopath Assoc. 2010 May;110(5):278-84.