Back pain Outcomes using Longitudinal Data (BOLD)

描述(由申请人提供)：下腰痛是导致功能受限和残疾的最重要原因之一，是医学研究所的优先情况，对于老年人来说仍然是一个特别重要的问题，老年人是AHRQ优先考虑的人群。虽然有许多指南关于对一般下腰痛人群使用诊断测试和治疗，但针对老年人的循证指南很少。这不仅仅是一个学术问题。2005年，腰痛每年的直接医疗费用为860亿美元，到2010年可能会上升到1000亿美元以上。尽管腰痛的发病率和成本都很高，但关于最常用的诊断测试和治疗的相对有效性，重要的问题仍然没有得到回答。我们的主要目标是建立一个大型的，以社区为基础的老年下腰痛患者登记。该注册将为严格的前瞻性研究提供基础，包括大型、实用、随机对照试验(RCT)。除了登记，我们还建议将患者纳入两项研究：1)对老年椎管狭窄患者进行随机对照试验，以评估联合使用硬膜外类固醇和局部麻醉药与单纯局部麻醉剂注射的有效性、成本和安全性；2)对新发下腰痛的老年患者进行早期高级成像(MRI和CT)与无高级成像的前瞻性观察队列研究。这些研究将作为登记册对比较效力研究的价值的示范项目。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痛护理，从相对不成熟的技术(例如人造椎间盘、基因组学)的早期市场渗透到广泛传播的成熟干预措施(例如核磁共振、物理治疗、脊柱融合)。该项目的总体目标是建立一个可持续和丰富的登记，以前瞻性地评估针对65岁以上腰痛患者的干预措施的有效性、安全性和成本效益。 公共卫生相关性：下腰痛是导致功能受限和残疾的最重要原因之一，是医学研究所的优先情况，对于AHRQ优先人群老年人来说，它仍然是一个特别重要的问题。该项目的总体目标是建立一个可持续和丰富的登记，以前瞻性地评估针对65岁以上腰痛患者的干预措施的有效性、安全性和成本效益。我们提出了3个具体目标：1)使用纵向数据(BOLD)登记建立腰痛预后登记；2)在老年椎管狭窄症患者(AHRQ优先人群)中进行一项随机对照试验(RCT)，以测试硬膜外类固醇注射(ESI)加局部麻醉剂(LA)是否比单独使用LA更有效；3)进行一项前瞻性、观察性队列研究，以比较早期(发病6周内)先进成像(MRI和CT)与非先进成像技术在疼痛、功能和后续资源利用方面的有效性。

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.