Research studies on the efficac y of chiropractic care should arise from the "gold standard" of research design, the randomized clinical trial (RCT). In this way, the relative efficacy of chiropractic care can be compared to other interventions or control groups in the same setting. Attention to specific criteria for quality research yields several challenges. The objective of this paper is to present the design of an RCT of chiropractic care versus drug therapy for subacute low back pain currently underway at Life University.
Low back pain is a major health care concern which has both social and economic impact. There is a need for research on acute and chronic low back pain due to its high incidence in the adult population. In addition, there is the concern that a simple backache may develop into chronic disabling back pain. Study of low back pain is difficult since acute back pain most often subsides spontaneously regardless of treatment, and chronic back pain is usually resistant to most all methods of treatment. The study design presented here concerns a more specific, less studied classification than acute or chronic back pain: subacute low back pain.
While there are many interventions for low back pain in the health care community, the focus of this study compares chiropractic care in the form of spinal adjustments to remove subluxations against medical care in the form of prescribed muscle relaxants. In addition to the two intervention groups, the double-blinded design also includes a control group receiving sham interventions.
Considerable effort has been made to address the criticisms of previous studies as well as the many challenges met along the way such as definition of the condition being studied and the specific interventions used, the use of meaningful outcome measures, and the production of a blinded control for chiropractic care. An RCT was designed and implemented following the recommendations of the World Health Organization initiative on low back pain management.
To date, newspaper advertisements have produced more than 85% of the patient leads. Although nearly 800 potential patients responded to advertising over a 14 month period, fewer than seven percent of the respondents met the inclusion criteria for the study.
Author Keywords: Chiropractic, Drug Therapy, Design, Randomized Clinical Trial, Subacute Low Back Pain
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