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

项目总结 美国正处于一场前所未有的痛苦管理危机之中。腰背痛(LBP)是最常见的 成年人的慢性疼痛状况，是全球残疾的主要原因。指导方针建议 近十年来，非药物治疗如脊柱手法和LBP的行为方法， 然而，人们对此的接受和遵守一直很差。此外，人们对这些治疗方法在癌症中的作用知之甚少。 慢性下腰痛(CLBP)的二级预防，特别是对有生物、心理和社会危险因素的患者。使用 不断上涨的成本，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，迫切需要研究预防慢性下腰痛的非药物治疗方法。 这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、非药理学的方法来降低LBP的总体负担 应对急性/亚急性LBP的生物、心理和社会方面的策略，并防止向cLBP过渡。 我们提出了一种新的随机混合试验，兼顾了有效性和实施。总数为1180个 患者将参加为期2-12周的非特异性LBP的研究，这些患者的发病风险为中等或高度。 CLBP。这项多点、主要是务实的第三阶段试验有两个主要目标。目标1将评估 脊柱手法疗法(SMT)、结构化自我管理(SSM)和SMT SSM的有效性 使用2x2析因设计的随机试验中的相对于常规医疗(UMC)。理疗师 (PT)和脊椎按摩师(DC)将提供SMT和SSM，初级保健临床医生将提供UMC。主要 结果是在12个月时预防慢性下腰痛；在6个月内从急性/亚急性下腰痛中恢复；以及 1年内累计减少疼痛和残疾。次要结果包括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有关 对可能影响成果解释和未来执行的干预措施的影响。定性的 数据将提供有关患者、提供者和卫生系统领导人对障碍和 促进者；定量数据收集将提供对干预应用、遵从性、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， 该项目通过提供确凿和普遍的证据，可以显著改变LBP管理 关于一线非药物干预措施，以解决儿童的生理和心理社会因素 慢性腰痛的预防。使用PTS和DC使患者能够参与健康的疼痛管理 行为，我们预计与LBP相关的残疾、生产力损失和对持续的医疗保健和 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.