Osteopathic Otitis Media Research Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Otitis Media With Effusion

Intervention / Treatment
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* Procedure: osteopathic manipulative medicine (OMM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Care Plus OMM<br>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)<br>* At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.<br>|
| No Intervention: Standard Care Only<br>Subjects will receive standard care only for otitis media from their regular referring physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media | For this study, the tympanogram was chosen to measure middle ear effusion. Three tympanogram readings from each ear included in the study were taken at the beginning of each of 5 Study Visits. For the intervention group, a second set of 3 tympanograms was taken immediately after the OMM on Visits 1, 2 and 3. All tympanograms were sent to a blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed from baseline over 4 weeks was computed by crosstabulating the intervention group by the normal/abnormal changes in tympanograms. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Middle Ear Effusion Immediately After OMM at Study Visit 2 | For this study, the tympanogram was chosen to measure middle ear effusion. For the SC+OMT Group during study visit 2, three tympanogram readings from each ear included in the study were taken prior to, and immediately after the intervention. The tympanograms were sent to the blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed between normal and abnormal from before and after the OMM was computed. | Before and immediately after OMM at study visit 2 | 
| Change in Middle Ear Effusion Immediately After OMM at Study Visit 3 | For this study, the tympanogram was chosen to measure middle ear effusion. For the SC+OMT Group during study visit 3, three tympanogram readings from each ear included in the study were taken prior to, and immediately after the intervention. The tympanograms were sent to the blinded audiologist, who chose the most healthy of the 3 tympanogram readings for interpretation, rating it according to standard protocols. A and C1 readings were considered normal and B and C2 readings were considered abnormal. The extent to which the tympanogram readings of each ear included in the study changed between normal and abnormal from before and after the OMM was computed. | Before and immediately after OMM at study visit 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otitis Media, Effusion, OMM, OMT, Resolution