Back pain Outcomes using Longitudinal Data (BOLD)

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DESCRIPTION (provided by applicant): Low back pain is one of the most important causes of functional limitation and disability, an Institute of Medicine priority condition, and it remains a particularly important problem for the elderly, an AHRQ priority population. While there are numerous guidelines regarding the use of diagnostic testing and treatments for the general low back pain population, there is a paucity of evidence-based guidelines for the elderly. This is more than a mere academic concern. The annual direct medical costs of low back pain were $86 billion in 2005 and by 2010 are likely to rise to over $100 billion. Despite the high prevalence and cost of low back pain, important questions remain unanswered regarding the comparative effectiveness of most commonly used diagnostic tests and treatments. Our primary goal is to establish a large, community-based registry of elderly patients with low back pain. This registry will provide a foundation for rigorous prospective studies including large, practical, randomized controlled trials (RCTs). Alongside the registry, we propose to enroll patients into two studies: 1) an RCT of elderly patients with spinal stenosis to evaluate the effectiveness, cost and safety of combined epidural steroid injections and local anesthetics compared with local anesthetic injections alone, and 2) a prospective observational cohort study of early advanced imaging (MRI and CT) compared to no advanced imaging in elderly patients with new episodes of low back pain. These studies will serve as demonstration projects for the value of the registry for comparative effectiveness research. The registry will provide the infrastructure for future studies to evaluate back pain care at multiple stages of development, from the early market penetration of relatively immature technologies (e.g. artificial discs, genomics) to widely disseminated mature interventions (e.g. MRI, physical therapy, spinal fusion). The overall goal of this project is to establish a sustainable and rich registry to evaluate prospectively the effectiveness, safety, and cost-effectiveness of interventions for patients over age 65 with low back pain. PUBLIC HEALTH RELEVANCE: Low back pain is one of the most important causes of functional limitation and disability, an Institute of Medicine priority condition, and it remains a particularly important problem for the elderly, an AHRQ priority population. The overall goal of this project is to establish a sustainable and rich registry to evaluate prospectively the effectiveness, safety, and cost-effectiveness of interventions for patients over age 65 with low back pain. We propose 3 specific aims: 1) To establish the Back pain Outcomes using Longitudinal Data (BOLD) registry; 2) To conduct a randomized controlled trial (RCT) in elderly patients (an AHRQ priority population) with spinal stenosis to test if the effectiveness of epidural steroid injections (ESI) plus local anesthetics (LA) is greater than LA alone; 3) To conduct a prospective, observational cohort study to compare the effectiveness of early (within 6 weeks of presentation) advanced imaging (MRI and CT) to no advanced imaging in elderly patients with new episodes of low back pain without radiculopathy with respect to pain, function and subsequent resource utilization.