This study, funded primarily by the American Osteopathic Association, is a multi-site national collaborative inquiry into the effect of Osteopathic Manipulative Treatment on the clinical course of children with recurrent otitis media.
Additional funding for training and travel is provided by the Robuck Fund of the Louisa Burns Osteopathic Research Committee of the American Academy of Osteopathy. Broad-based in-kind support is also provided by the OSU College of Osteopathic Medicine.
Patients eligible for the study include:
- children from 3-months to 6 and a half years.
- children with three ear infections in the previous six months or four ear infections in the previous year as defined by:
- irritability, fever or ear pain
- evidence of abnormal tympanic membrane findings
- symptoms cleared between each separate ear infection
Exclusion criteria includes:
- prior surgery of the head and neck
- known chromosomal anomalies
- immune defects
Children who undergo surgery (other than ENT) during the course of the study are eliminated from the study.
The participants are chosen from a practice separate from the treating osteopathic physicians. The referring physician is blind to the patients randomized group assignment (into treatment or control group), or to any of the clinical data obtained by the study until its conclusion.
All study participants receive:
- evaluations at the beginning and end of the study both osteopathically and by audiogram.
- monthly tympanograms and monthly behavior rating questionnaires.
Patients in the treatment group receive:
- osteopathic manipulative treatment nine times in the course of six months.
Patients in the control group receive:
- an equal number of encounters, which do not involve hands-on contact.
This project is a follow-up of a pilot feasibility study funded by the American Academy of Osteopathy. In that pilot study, we completed 19 of the projected 20 patients utilizing one pediatrician. Statistical analysis of this pilot study is not yet complete.
The present grant is designed for the same protocol in up to 10 different sites across the country. Our goal is to process 100 patients, 40 from the central site and 60 from subcontractors. Those other sites are: