Otitis Media With Effusion
Conditions
Keywords
Otitis Media, Effusion, OMM, OMT, Resolution
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.
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.
Interventions
At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
Sponsors
University of New England
American Academy of Osteopathy
Osteopathic Research Center
West Virginia School of Osteopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 2 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Standard Care Only Subjects will receive standard care only for otitis media from their regular referring physician | 24 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion criteria met at first visit | 7 | 5 |
Baseline characteristics
| Characteristic | Standard Care Plus OMM | Standard Care Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 24 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 28 participants | 24 participants | 52 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 24 |
| serious Total, serious adverse events | 0 / 28 | 0 / 24 |
Outcome results
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.
Time frame: 1 month
Population: 4 ears, from 2 subjects, were removed from the SC+OMM group final analysis due to no interpretable readings obtained during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Care Plus OMM (SC+OMM) | Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media | Improvement in MEE at 2 weeks | 26 Ears |
| Standard Care Plus OMM (SC+OMM) | Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media | No Improvement in MEE at 2 weeks | 12 Ears |
| Standard Care Only (SCO) | Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media | Improvement in MEE at 2 weeks | 16 Ears |
| Standard Care Only (SCO) | Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media | No Improvement in MEE at 2 weeks | 22 Ears |
Comparison: Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.p-value: 0.0295% CI: [0.15, 2.03]Chi-squared
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.
Time frame: Before and immediately after OMM at study visit 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Care Plus OMM (SC+OMM) | Change in Middle Ear Effusion Immediately After OMM at Study Visit 2 | Resolution of MEE after OMM at Visit 2 | 5 ears |
| Standard Care Plus OMM (SC+OMM) | 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 |
| Standard Care Only (SCO) | Change in Middle Ear Effusion Immediately After OMM at Study Visit 2 | Resolution of MEE after OMM at Visit 2 | 6 ears |
| Standard Care Only (SCO) | Change in Middle Ear Effusion Immediately After OMM at Study Visit 2 | No Resolution of MEE at end of OMM at visit 2 | 23 ears |
p-value: 0.3295% CI: [-1, 1.62]Chi-squared
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.
Time frame: Before and immediately after OMM at study visit 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Care Plus OMM (SC+OMM) | Change in Middle Ear Effusion Immediately After OMM at Study Visit 3 | Resolution of MEE at Visit 3 | 12 ears |
| Standard Care Plus OMM (SC+OMM) | Change in Middle Ear Effusion Immediately After OMM at Study Visit 3 | No Resolution of MEE after OMM at Visit 3 | 19 ears |
| Standard Care Only (SCO) | Change in Middle Ear Effusion Immediately After OMM at Study Visit 3 | Resolution of MEE at Visit 3 | 13 ears |
| Standard Care Only (SCO) | Change in Middle Ear Effusion Immediately After OMM at Study Visit 3 | No Resolution of MEE after OMM at Visit 3 | 25 ears |
p-value: 0.3195% CI: [-0.78, 1.28]Chi-squared