Otitis Media With EffusionOOMRSNCT00520039
Osteopathic Otitis Media Research Study
A study testing osteopathic manipulative medicine (OMM) in people with Otitis Media With Effusion, run by West Virginia School of Osteopathic Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- osteopathic manipulative medicine (OMM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New England College of Osteopathic Medicine
Biddeford, Maine, 04005
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, 24901
About this study
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
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.
Read the 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.
- Conditions
- Otitis Media With Effusion
- Being tested
- osteopathic manipulative medicine (OMM)
- Keywords
- Otitis Media, Effusion, OMM, OMT, Resolution
- Medical subject headings
- Otitis Media with Effusion, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative medicine (OMM)Procedure or surgery
At each of the first three study visits, all subjects in the osteopathic manipulative medicine (OMM) group will receive OMM using the prescribed protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Plus OMM | Experimental | 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. Receives: Procedure: osteopathic manipulative medicine (OMM) |
| Standard Care Only | No intervention | Subjects will receive standard care only for otitis media from their regular referring physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: Before and immediately after OMM at study visit 2
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.
Measured: Before and immediately after OMM at study visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia School of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of New England, American Academy of Osteopathy, Osteopathic Research Center
- Responsible party
- Principal investigator, Karen M. Steele, D.O., FAAO, West Virginia School of Osteopathic Medicine
- Investigators
- Karen M Steele, D.O., Principal investigator, West Virginia School of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520039
- Sponsor's protocol ID
- KS5172007
- Acronym
- OOMRS
- Status last verified
- Aug 2017
- First submitted
- 22 Aug 2007
- Last updated
- 26 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Steele KM, Carreiro JE, Viola JH, Conte JA, Ridpath LC. Effect of osteopathic manipulative treatment on middle ear effusion following acute otitis media in young children: a pilot study. J Am Osteopath Assoc. 2014 Jun;114(6):436-47. doi: 10.7556/jaoa.2014.094.
PubMed 24917631Steele 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. 2010 May;110(5):278-84.
PubMed 20538749
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00520039
- Acronym / sponsor ID
- OOMRS / KS5172007
- Conditions
- Otitis Media With Effusion
- Keywords
- Otitis Media, Effusion, OMM, OMT, Resolution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- West Virginia School of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- University of New England, American Academy of Osteopathy, Osteopathic Research Center
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Posted 26 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Plus OMM | Experimental | Procedure: osteopathic manipulative medicine (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. |
| Standard Care Only | No intervention | –Subjects will receive standard care only for otitis media from their regular referring physician |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Standard Care Plus OMM |
Primary outcome
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.
2 secondary outcomes
Change in Middle Ear Effusion Immediately After OMM at Study Visit 2
Time frame: Before and immediately after OMM at study visit 2
Change in Middle Ear Effusion Immediately After OMM at Study Visit 3
Time frame: Before and immediately after OMM at study visit 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24917631Steele KM, Carreiro JE, Viola JH, Conte JA, Ridpath LC. Effect of osteopathic manipulative treatment on middle ear effusion following acute otitis media in young children: a pilot study. J Am Osteopath Assoc. 2014 Jun;114(6):436-47. doi: 10.7556/jaoa.2014.094.
- Derived from this study: PubMed 20538749Steele 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. 2010 May;110(5):278-84.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Steele, D.O. principal investigator
West Virginia School of Osteopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic manipulative medicine (OMM) in people with Otitis Media With Effusion, run by West Virginia School of Osteopathic Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00520039, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.