A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with effusion in children.
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.


CONCLUSIONS
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.
Sawyer
C E
CE
Academic Affairs, Northwestern College of Chiropractic, Bloomington, Minnesota 55431, USA.
Evans
R L
RL
Boline
P D
PD
Branson
R
R
Spicer
A
A
D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D008349:Manipulation, Orthopedic / Q000379:methods; D020393:Manipulation, Spinal / Q000379:methods*; D010034:Otitis Media with Effusion / Q000628:therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D016896:Treatment Outcome