Back pain Outcomes using Longitudinal Data (BOLD)

描述（由申请人提供）：腰痛是功能限制和残疾的最重要原因之一，是医学研究所优先考虑的疾病，对于老年人来说，腰痛仍然是一个特别重要的问题，老年人是AHRQ优先考虑的人群。虽然有许多关于使用诊断测试和治疗一般腰痛人群的指南，但缺乏针对老年人的循证指南。这不仅仅是一个学术问题。2005年，每年腰痛的直接医疗费用为860亿美元，到2010年可能会上升到1000亿美元以上。尽管腰痛的发病率高，成本高，但关于最常用的诊断测试和治疗的相对有效性的重要问题仍未得到解答。我们的主要目标是建立一个大型的，以社区为基础的老年腰痛患者登记。该注册表将为包括大型、实用、随机对照试验（rct）在内的严格前瞻性研究提供基础。除了登记外，我们建议将患者纳入两项研究：1)一项老年椎管狭窄患者的随机对照试验，以评估硬膜外类固醇注射和局部麻醉剂联合注射与单独局部麻醉剂注射相比的有效性、成本和安全性；2)一项前瞻性观察队列研究，对新发腰痛的老年患者进行早期晚期影像学（MRI和CT）与未进行晚期影像学的比较。这些研究将作为示范项目，证明登记册对比较效力研究的价值。从相对不成熟的技术（如人工椎间盘、基因组学）的早期市场渗透到广泛传播的成熟干预措施（如MRI、物理治疗、脊柱融合），该登记处将为未来的研究提供基础设施，以评估多个发展阶段的背部疼痛护理。该项目的总体目标是建立一个可持续和丰富的注册表，以前瞻性地评估65岁以上腰痛患者干预措施的有效性、安全性和成本效益。

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.