Osteopathic Otitis Media Research Study

Otitis Media With Effusion Clinical Trial

— OOMRS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520039
• Other study ID #: KS5172007
• Status: Completed
• Phase: N/A
• First received: August 22, 2007
• Last updated: August 28, 2017
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2017
• Source: West Virginia School of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Procedure:
• osteopathic manipulative medicine (OMM)
At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
West Virginia School of Osteopathic Medicine	American Academy of Osteopathy, Osteopathic Research Center, University of New England

Country where clinical trial is conducted

United States, 

Outcome

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