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Osteopathic Otitis Media Research Study (OOMRS)

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ClinicalTrials.gov Identifier: NCT00520039
Recruitment Status : Completed
First Posted : August 23, 2007
Results First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
University of New England
American Academy of Osteopathy
Osteopathic Research Center
Information provided by (Responsible Party):
Karen M. Steele, D.O., FAAO, West Virginia School of Osteopathic Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Procedure: osteopathic manipulative medicine (OMM) Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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.
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.

No Intervention: Standard Care Only
Subjects will receive standard care only for otitis media from their regular referring physician



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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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Ages Eligible for Study:   6 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520039


Locations
United States, Maine
University of New England College of Osteopathic Medicine
Biddeford, Maine, United States, 04005
United States, West Virginia
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, United States, 24901
Sponsors and Collaborators
West Virginia School of Osteopathic Medicine
University of New England
American Academy of Osteopathy
Osteopathic Research Center
Investigators
Principal Investigator: Karen M Steele, D.O. West Virginia School of Osteopathic Medicine

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
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. May 2010, Vol. 110, 278-284.
Clinical Study Report  This link exits the ClinicalTrials.gov site
Steele KM, Carreiro JE, Viola, JH, Conte, JA, Ridpath, LC. "The effect of osteopathic manipulative medicine on middle ear effusion following acute otitis media in young children: a pilot study." J Am Osteopath Assoc June 2014, Vol. 114, 436-447

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen M. Steele, D.O., FAAO, Professor Emerita, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT00520039     History of Changes
Other Study ID Numbers: KS5172007
First Posted: August 23, 2007    Key Record Dates
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Karen M. Steele, D.O., FAAO, West Virginia School of Osteopathic Medicine:
Otitis Media
Effusion
OMM
OMT
Resolution

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases