- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00520039
Osteopathic Otitis Media Research Study (OOMRS)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maine
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Biddeford, Maine, United States, 04005
- University of New England College of Osteopathic Medicine
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West Virginia
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Lewisburg, West Virginia, United States, 24901
- West Virginia School of Osteopathic Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
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No Intervention: Standard Care Only
Subjects will receive standard care only for otitis media from their regular referring physician
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
Time Frame: 1 month
|
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.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Middle Ear Effusion Immediately After OMM at Study Visit 2
Time Frame: Before and 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.
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Before and immediately after OMM at study visit 2
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Change in Middle Ear Effusion Immediately After OMM at Study Visit 3
Time Frame: Before and 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.
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Before and immediately after OMM at study visit 3
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Collaborators and Investigators
Investigators
- Principal Investigator: Karen M Steele, D.O., West Virginia School of Osteopathic Medicine
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KS5172007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Alcon ResearchCompletedOtitis Media With Effusion in Children | Otitis Media Recurrent
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Yuinvent Innovations Ltd.UnknownOtitis Media With Effusion
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