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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520039
Other study ID # KS5172007
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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