Clinical Coordinating Center for Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain (PACBACK)

项目摘要 美国正处于前所未有的疼痛管理危机之中。下背痛（LBP）是最常见的 成人慢性疼痛状况和全球残疾的主要原因。指南建议 近十年来，LBP的非药物治疗，如脊柱推拿和行为方法， 然而，接受和遵守情况一直很差。此外，对这些治疗在治疗中的作用知之甚少。 慢性LBP（cLBP）的二级预防，特别是对于具有生物心理社会风险因素的患者。与 不断增长的成本，越来越多的无效证据，以及常用药物治疗的危害， 包括阿片类药物在内，迫切需要研究用于预防cLBP的非药物治疗方法 可以很容易地转化为实践。 长期目标是通过测试可扩展的，一线的，非药物的， 解决急性/亚急性LBP的生物心理社会方面并防止向cLBP过渡的策略。 我们提出了一种新的随机混合试验解决有效性和实施。共1180个 将招募持续时间为2-12周的非特异性LBP患者，这些患者处于中度或高度发展风险， cLBP。这一多中心、主要是务实的III期试验有两个主要目标。目标1将评估 脊柱推拿疗法（SMT）、结构化自我管理（SSM）和SMT+SSM的有效性 相对于家庭医疗护理（UMC），在一项随机试验中使用2x2析因设计。物理治疗师 (PT)脊医（DC）将提供SMT和SSM，初级保健临床医生将提供UMC。初级 结果是在12个月时预防cLBP;在6个月时从急性/亚急性LBP恢复;以及 1年内疼痛和残疾的累积减少。次要结局包括PROMIS-29、生产力 损失，医疗保健和药物使用（包括阿片类药物）。Aim 2将使用混合方法收集以下数据： 对干预措施的影响，可能会影响对结果的解释和未来的执行。定性 数据将提供有关患者、提供者和卫生系统领导人对障碍的看法的背景， 促进者;定量数据收集将提供对干预应用、依从性、保真度和 供应商信心 与国家补充和综合健康中心（NCCIH）2016年战略计划保持一致， 该项目可以通过提供明确的和可推广的证据来显著改变LBP管理 关于一线的非药物干预措施， 预防cLBP使用PT和DC使患者能够进行健康的疼痛管理 行为，我们预计LBP相关的残疾，生产力损失，以及对持续医疗保健的依赖， 药物使用（包括阿片类药物）将减少。

PROJECT SUMMARY The US is in the midst of an unprecedented pain management crisis. Low back pain (LBP) is the most common chronic pain condition in adults and the leading cause of disability worldwide. Guidelines have recommended non-pharmacologic treatments like spinal manipulation and behavioral approaches for LBP for nearly a decade, yet uptake and adherence has been poor. Moreover, little is known about the role of these treatments in the secondary prevention of chronic LBP (cLBP), especially for patients with biopsychosocial risk factors. With burgeoning costs, mounting evidence of ineffectiveness, and harms of commonly used drug treatments, including opioids, there is a critical need for research on non-pharmacological treatments for cLBP prevention that can be readily translated to practice. The long-term objective is to reduce overall LBP burden by testing scalable, first-line, non-pharmacologic strategies that address the biopsychosocial aspects of acute/sub-acute LBP and prevent transition to cLBP. We propose a novel randomized hybrid trial addressing both effectiveness and implementation. A total of 1180 patients will be enrolled with nonspecific LBP of 2-12 weeks duration, at medium or high risk of developing cLBP. This multi-site, predominantly pragmatic, phase III trial has two main aims. Aim 1 will assess the effectiveness of Spinal Manipulation Therapy (SMT), Structured Self-Management (SSM), and SMT+SSM relative to Usual Medical Care (UMC) in a randomized trial using a 2x2 factorial design. Physical therapists (PT) and chiropractors (DC) will deliver SMT and SSM, and primary care clinicians will deliver UMC. Primary outcomes are prevention of cLBP at 12 months; recovery from acute/sub-acute LBP at 6 months; and cumulative reduction of pain and disability over 1 year. Secondary outcomes include PROMIS-29, productivity loss, healthcare and medication use (including opioids). Aim 2 will use mixed methods to gather data about influences on the interventions that could affect interpretation of results and future implementation. Qualitative data will lend context regarding patients', providers', and health system leaders' perceptions of barriers and facilitators; quantitative data collection will offer insight into intervention application, adherence, fidelity, and provider confidence. Aligned with the National Center for Complementary and Integrative Health's (NCCIH) Strategic Plan 2016, this project can significantly transform LBP management by providing definitive and generalizable evidence regarding front-line, non-pharmacologic interventions addressing physical and psychosocial factors for the prevention of cLBP. Using PTs and DCs to empower patients to engage in healthy pain management behaviors, we anticipate LBP-related disability, productivity loss, and reliance on continued healthcare and medication use (including opioids) will be reduced.