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Published on: May 6, 2014
A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with
C E Sawyer1, R L Evans, P D Boline
1Academic Affairs, Northwestern College of Chiropractic, Bloomington, Minnesota 55431, USA.
Insights
This pilot study found that recruiting for a randomized controlled trial on chiropractic spinal manipulative therapy (SMT) for pediatric otitis media with effusion is feasible. Patient participation and compliance were high, though objective outcome measures require refinement.
Area of Science:
- Pediatric medicine
- Integrative health
- Clinical trial methodology
Background:
- Otitis media with effusion (OME) is a prevalent and expensive pediatric condition.
- Anecdotal evidence suggests chiropractic care may help OME, but research is limited.
Purpose of the Study:
- To assess the feasibility of a full-scale randomized clinical trial (RCT) on chiropractic spinal manipulative therapy (SMT) for chronic OME in children.
- To evaluate recruitment strategies and patient compliance for a future RCT.
Main Methods:
- Prospective, parallel-group, observer-blinded, randomized feasibility study.
- 22 children (6 months–6 years) received active or placebo chiropractic SMT.
- Otoscopy, tympanometry, and daily diaries were used for data collection.
Main Results:
- Newspaper advertisements yielded 105 responses, with 20 patients randomized.
- Excellent compliance with treatment protocols and daily diaries was observed.
- No serious side effects were reported for either active or placebo SMT.
Conclusions:
- Recruitment for an RCT is feasible, potentially enhanced by medical collaboration.
- Patients and parents are willing and able to participate in SMT trials.
- Objective outcome assessments (tympanometry, otoscopy) were challenging and need experienced examiners in future studies.
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.
