OOMRS: Osteopathic Otitis Media Research Study

• Sponsor: West Virginia School of Osteopathic Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00520039
• Collaborator: University of New England (Other), American Academy of Osteopathy (Other), Osteopathic Research Center (Other)
• Enrollment: 52
• Locations: 2
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 26
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• 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: Sep 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of New England College of Osteopathic Medicine	Biddeford	Maine	United States	04005
2	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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karen M. Steele, D.O., FAAO, Professor Emerita, West Virginia School of Osteopathic Medicine
• ClinicalTrials.gov Identifier: NCT00520039
• Other Study ID Numbers: KS5172007
• First Posted: Aug 23, 2007
• Last Update Posted: Mar 26, 2018
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Karen M. Steele, D.O., FAAO, Professor Emerita, West Virginia School of Osteopathic Medicine: Otitis Media; Effusion; OMM; OMT; Resolution
• Additional relevant MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion

Study Results

Participant Flow

Recruitment Details	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 Detail	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.

Arm/Group Title	Standard Care Plus OMM (SC+OMM)	Standard Care Only (SCO)
Arm/Group Description	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.	Subjects will receive standard care only for otitis media from their regular referring physician
Period Title: Overall Study
STARTED	28	24
COMPLETED	21	19
NOT COMPLETED	7	5

Baseline Characteristics

Arm/Group Title	Standard Care Plus OMM	Standard Care Only	Total
Arm/Group Description	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.	Subjects will receive standard care only for otitis media from their regular referring physician	Total of all reporting groups
Overall Participants	28	24	52
Age (Count of Participants)
<=18 years	28 100%	24 100%	52 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (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 (participants) [Number]
United States	28 100%	24 100%	52 100%

Outcome Measures

1. Primary Outcome

Title	Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

4 ears, from 2 subjects, were removed from the SC+OMM group final analysis due to no interpretable readings obtained during the study.

Arm/Group Title	Standard Care Plus OMM (SC+OMM)	Standard Care Only (SCO)
Arm/Group Description	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.	Subjects will receive standard care only for otitis media from their regular referring physician
Measure Participants	19	19
Measure Ears	38	38
Improvement in MEE at 2 weeks	26	16
No Improvement in MEE at 2 weeks	12	22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care Plus OMM (SC+OMM), Standard Care Only (SCO)
	Comments	Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Chi-squared
	Comments	df = 1
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.15 to 2.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.94
	Estimation Comments	The denominator of the Odds ratio represents the odds of improvement for the Standard Care Only (SCO) group.

2. Secondary Outcome

Title	Change in Middle Ear Effusion Immediately After OMM at Study Visit 2
Description	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.
Time Frame	Before and immediately after OMM at study visit 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Before OMM	After OMM
Arm/Group Description	Result of tympanogram reading before 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.	Result of tympanogram reading after 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.
Measure Participants	19	19
Measure ears	31	29
Resolution of MEE after OMM at Visit 2	5	6
No Resolution of MEE at end of OMM at visit 2	26	23

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care Plus OMM (SC+OMM), Standard Care Only (SCO)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	Chi-squared
	Comments	df = 1
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; -1.00 to 1.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.31
	Estimation Comments	The odds of Resolution of MEE before OMT is represented in the denominator of the odds ratio

3. Secondary Outcome

Title	Change in Middle Ear Effusion Immediately After OMM at Study Visit 3
Description	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.
Time Frame	Before and immediately after OMM at study visit 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Before OMM	After OMM
Arm/Group Description	Result of tympanogram reading before 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.	Result of tympanogram reading after 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.
Measure Participants	19	19
Measure ears	31	29
Resolution of MEE at Visit 3	12	13
No Resolution of MEE after OMM at Visit 3	19	25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care Plus OMM (SC+OMM), Standard Care Only (SCO)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.31
	Comments
	Method	Chi-squared
	Comments	df = 1
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; -0.78 to 1.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.03
	Estimation Comments

Adverse Events

Time Frame	1month
Adverse Event Reporting Description	Completed at the start of each study visit by the Research Assistant, and during the intervention by the OMM treatment provider
Arm/Group Title	Standard Care Plus OMM		Standard Care Only
Arm/Group Description	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. There were no Serious Adverse Events reported.		Subjects will receive standard care only for otitis media from their regular referring physician. There were no Serious Adverse Events reported.
All Cause Mortality
	Standard Care Plus OMM		Standard Care Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Care Plus OMM		Standard Care Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Standard Care Plus OMM		Standard Care Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/24 (0%)

Limitations/Caveats

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.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.