Trial Outcomes & Findings for Osteopathic Otitis Media Research Study (NCT NCT00520039)
NCT ID: NCT00520039
Last Updated: 2018-03-26
Results Overview
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.
COMPLETED
NA
52 participants
1 month
2018-03-26
Participant Flow
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
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
24
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Exclusion criteria met at first visit
|
7
|
5
|
Baseline Characteristics
Osteopathic Otitis Media Research Study
Baseline characteristics by cohort
| Measure |
Standard Care Plus OMM
n=28 Participants
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
n=24 Participants
Subjects will receive standard care only for otitis media from their regular referring physician
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
24 participants
n=107 Participants
|
52 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 4 ears, from 2 subjects, were removed from the SC+OMM group final analysis due to no interpretable readings obtained during the study.
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.
Outcome measures
| Measure |
Standard Care Plus OMM (SC+OMM)
n=38 Ears
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)
n=38 Ears
Subjects will receive standard care only for otitis media from their regular referring physician
|
|---|---|---|
|
Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
Improvement in MEE at 2 weeks
|
26 Ears
|
16 Ears
|
|
Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media
No Improvement in MEE at 2 weeks
|
12 Ears
|
22 Ears
|
SECONDARY outcome
Timeframe: Before and immediately after OMM at study visit 2For 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.
Outcome measures
| Measure |
Standard Care Plus OMM (SC+OMM)
n=31 ears
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)
n=29 ears
Subjects will receive standard care only for otitis media from their regular referring physician
|
|---|---|---|
|
Change in Middle Ear Effusion Immediately After OMM at Study Visit 2
Resolution of MEE after OMM at Visit 2
|
5 ears
|
6 ears
|
|
Change in Middle Ear Effusion Immediately After OMM at Study Visit 2
No Resolution of MEE at end of OMM at visit 2
|
26 ears
|
23 ears
|
SECONDARY outcome
Timeframe: Before and immediately after OMM at study visit 3For 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.
Outcome measures
| Measure |
Standard Care Plus OMM (SC+OMM)
n=31 ears
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)
n=29 ears
Subjects will receive standard care only for otitis media from their regular referring physician
|
|---|---|---|
|
Change in Middle Ear Effusion Immediately After OMM at Study Visit 3
Resolution of MEE at Visit 3
|
12 ears
|
13 ears
|
|
Change in Middle Ear Effusion Immediately After OMM at Study Visit 3
No Resolution of MEE after OMM at Visit 3
|
19 ears
|
25 ears
|
Adverse Events
Standard Care Plus OMM
Standard Care Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Karen Steele
West Virginia School of Osteopathic Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place