Otitis Media With Effusion Clinical Trial
— OOMRSOfficial 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
Verified date | August 2017 |
Source | West Virginia School of Osteopathic Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 2 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of New England College of Osteopathic Medicine | Biddeford | Maine |
United States | West Virginia School of Osteopathic Medicine | Lewisburg | West Virginia |
Lead Sponsor | Collaborator |
---|---|
West Virginia School of Osteopathic Medicine | American Academy of Osteopathy, Osteopathic Research Center, University of New England |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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