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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Otitis Media With Effusion
Intervention: Procedure: osteopathic manipulative medicine (OMM)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment dates: September 2007 through May 2009 Site: medical clinics of 2 colleges of osteopathic medicine Location: mid-Atlantic and Northeast areas of the United States

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
52 subjects were enrolled and randomized into the two study groups. 5 subjects in the SCO group and 7 subjects in the SC+OMM group were excluded from the study due to having a normal tympanogram on the first study visit.

Reporting Groups
  Description
Standard Care Plus OMM (SC+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.

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.

Standard Care Only (SCO) Subjects will receive standard care only for otitis media from their regular referring physician

Participant Flow:   Overall Study
    Standard Care Plus OMM (SC+OMM)   Standard Care Only (SCO)
STARTED   28   24 
COMPLETED   21   19 
NOT COMPLETED   7   5 
Exclusion criteria met at first visit                7                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
52 participants were enrolled and 12 excluded due to normal tympanograms at first study visit, leaving 19 subjects in the SCO and 21 subjects in the SC+OMM group.

Reporting Groups
  Description
Standard Care Plus OMM Subjects will receive active intervention with osteopathic manipulative medicine (OMM) using a prescribed standardized treatment protocol which is age appropriate, at each of the first 3 study visits. Subjects will also receive standard care for otitis media from their referring physician.
Standard Care Only Subjects will receive standard care only for otitis media from their regular referring physician
Total Total of all reporting groups

Baseline Measures
   Standard Care Plus OMM   Standard Care Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   24   52 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      28 100.0%      24 100.0%      52 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  42.9%      11  45.8%      23  44.2% 
Male      16  57.1%      13  54.2%      29  55.8% 
Region of Enrollment 
[Units: Participants]
     
United States   28   24   52 


  Outcome Measures

1.  Primary:   Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media   [ Time Frame: 1 month ]

2.  Secondary:   Change in Middle Ear Effusion Immediately After OMM at Study Visit 2   [ Time Frame: Before and immediately after OMM at study visit 2 ]

3.  Secondary:   Change in Middle Ear Effusion Immediately After OMM at Study Visit 3   [ Time Frame: Before and immediately after OMM at study visit 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One site closed after year 1 due to lower than expected subject recruitment. Lower than expected recruitment overall.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Karen Steele
Organization: West Virginia School of Osteopathic Medicine
phone: (304)667-4255
e-mail: ksteele@osteo.wvsom.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Karen M. Steele, D.O., FAAO, West Virginia School of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT00520039     History of Changes
Other Study ID Numbers: KS5172007
First Submitted: August 22, 2007
First Posted: August 23, 2007
Results First Submitted: November 10, 2016
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018