N/A
Completed N=52
Osteopathic Otitis Media Research Study
Otitis Media With Effusion
Source: ClinicalTrials.gov NCT00520039 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media — 26; 16; 12; 22 Ears — p=0.02
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media |
26; 16; 12; 22 | 0.02 sig |
| SECONDARY Change in Middle Ear Effusion Immediately After OMM at Study Visit 2 |
5; 6; 26; 23 | 0.32 |
| SECONDARY Change in Middle Ear Effusion Immediately After OMM at Study Visit 3 |
12; 13; 19; 25 | .31 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00520039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.