Methodology and demographics of a single blinded, randomized controlled trial of chiropractic compared to physical thera
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CHIROPRACTIC & MANUAL THERAPIES
STUDY PROTOCOL
Open Access
Methodology and demographics of a single blinded, randomized controlled trial of chiropractic compared to physical therapy for balance impairments in community dwelling geriatric patients with or without low back pain Dennis E Enix1*†, Kasey L Sudkamp1†, Theodore K Malmstrom2† and Joseph H Flaherty3†
Abstract Background: Postural control problems effect between 28% and 35% of individuals over the age 65 and increases with age. Musculoskeletal pain in the elderly impacts 20% to 49% of people between the ages of 65 and 75, is a leading falls risk factor, and a robust predictor of morbidity. Polypharmacy in the management of chronic pain is common in the geriatric population. Conservative treatment options for balance and back pain are underrepresented in scientific literature. Methods: The methods and demographics for a prospective, randomized controlled single blinded clinical trial are described. This study evaluated the use of either chiropractic care or physical therapy as a treatment for patients with balance problems and with low back pain (68.5%) or without low back pain (31.5%) in the geriatric population. One hundred and sixty eight consecutively enrolled community dwelling adults between 60 and 85 years old (72.8 +/− 6.8) were randomly assigned to 6 weeks of either chiropractic care or physical therapy (12 – 18 visits). Testing occurred prior to randomization, after 6 weeks of treatment, and again 6 weeks later. Functional and self-report outcome measures for balance included the Berg Balance Scale, Performance Oriented Mobility Assessment, Timed Up and Go Test, and NeuroCom balance tests. Pain was assessed with the Visual Analog Scale, 21-Point Box Scale, and pressure algometry. Quality of life healthcare questionnaires included the Oswestry, the SF-36, and the Falls Efficacy Scale for confidence in performing everyday activities. Data analysis for this intent-to-treat design was a mixed-model analysis of variance (ANOVA) (p < 0.05) and Bonferroni correction (p < 0.017 and p < 0.025). This study was set in a university biomedical and healthcare research facility and university ethics committee approval was obtained and written informed consent was given by all study participants. Conclusion: The methodology of this multimodal treatment protocol for balance disorders and low back pain in the geriatric population and patient demographics are described in this paper. Additional research in this area is needed for this growing at risk population. Trial registration: NCT02031562. Keywords: Balance, Falls, Geriatric, Back pain, Chiropractic, Physical therapy
* Correspondence: [email protected] † Equal contributors 1 Research Division, Logan University, 1851 Schoettler Rd, Chesterfield, MO 60317, USA Full list of author information is available at the end of the article © 2014 Enix et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org
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