A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with effusion in children
Received 15 September 1998
Charles E. Sawyer, DCa, Roni L. Evans, DCb, Patrick D. Boline, DCc, Richard Branson, DCd, Anne Spicer, DCe
Journal of Manipulative and Physiological Therapeutics
Abstract
Background: Pediatric otitis media with effusion is a common and costly condition. Although chiropractors have anecdotally claimed success in treating otitis media, there is little research to support their claims. Objective: A pilot study was undertaken for the purpose of assessing the feasibility of conducting a full-scale randomized clinical trial investigating the efficacy of chiropractic spinal manipulative therapy (SMT) for children with chronic otitis media with effusion. Methods: This study was a prospective, parallel-group, observer-blinded, randomized feasibility study. Twenty-two patients, ages 6 months to 6 years, received either active chiropractic SMT or placebo chiropractic SMT. Otoscopy and tympanometry were used to create a middle ear status profile, and daily diaries were collected. Results: Five newspaper advertisements over 6 months generated 105 responses. Twenty patients subsequently qualified and were randomized into the study. Collection of tympanometric and otoscopic data proved to be challenging. Compliance with the treatment and evaluation protocols and daily diaries was excellent. There were no reports of serious side effects as a result of either the active or placebo chiropractic treatments. Conclusion: Recruitment for a randomized controlled trial is feasible and could be enhanced by medical collaboration. Patients and parents are able and willing to participate in a study comparing active SMT and placebo SMT. Parents were extremely compliant with the daily diaries, suggesting that similar quality-of-life and functional status measures can be successfully used in a larger trial. We found the objective outcomes assessment involving tympanometry and otoscopy extremely challenging and should be performed by experienced examiners in future studies. (J Manipulative Physiol Ther 1999; 22:292Ò8)
Keywords: Chiropractic, Otitis Media, Pediatrics
a Vice President for Academic Affairs, Northwestern College of Chiropractic, Bloomington, Minnesota
b Assistant professor, Wolfe-Harris Center for Clinical Studies, Northwestern College of Chiropractic, Bloomington, Minnesota
c Assistant professor, Wolfe-Harris Center for Clinical Studies, Northwestern College of Chiropractic, Bloomington, Minnesota
d Assistant professor, Wolfe-Harris Center for Clinical Studies, Northwestern College of Chiropractic, Bloomington, Minnesota
e Assistant professor, Wolfe-Harris Center for Clinical Studies, Northwestern College of Chiropractic, Bloomington, Minnesota
☆ Submit reprint requests to: Charles E. Sawyer, DC, Wolfe-Harris Center for Clinical Studies, Northwestern College of Chiropractic, 2501 W 84th St, Bloomington, MN 55431.
☆☆ Supported by the Foundation for Chiropractic Education and Research by means of a restricted grant from the National Chiropractic Mutual Insurance Company.
PII: S0161-4754(99)70061-8
© 1999 JMPT. Published by Elsevier Inc. All rights reserved.
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Researcher says: | 2010-10-14 11:40:50 |
| This study does nothing but identify the possibility that a study could take place. This study does not propose or refut that otitis media with effusion in children could or could not be cured by spinal manipulation. | ||
Comments: 1