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

项目摘要 美国正处于前所未有的疼痛管理危机之中。准则 推荐的非药物治疗，如脊柱推拿和行为 近十年来，LBP的方法，但吸收和遵守一直很差。此外，委员会认为， 关于这些治疗在慢性LBP二级预防中的作用知之甚少 （cLBP），特别是对于有生物心理社会风险因素的患者。随着成本的上升， 无效的证据，以及常用药物治疗的危害，包括阿片类药物， 迫切需要研究用于预防cLBP的非药物治疗， 很容易转化为实践。 长期目标是通过测试可扩展的、一线的、非 解决急性/亚急性LBP的生物心理社会方面的药理学策略， 防止转化为cLBP。我们正在完成一项新的随机混合试验， 有效性和执行。共有1000名患者入选， 持续2-12周的LBP，处于发展cLBP的中等或高风险。这个多站点， 第三阶段审判主要是务实的，有两个主要目标。目标1将评估有效性 脊柱推拿疗法（SMT），结构化自我管理（SSM），和SMT+SSM 相对于医疗护理（MC），在一项随机试验中使用2x2析因设计。物理 治疗师（PT）和脊医（DC）将提供SMT和SSM，初级保健临床医生 我将提供MC。主要结局是在12个月时预防cLBP（通过LBP测量） 超过1年的影响和平均疼痛强度和下背部残疾。次要结局 包括PROMIS-29、生产力损失、保健和药物使用（包括阿片类药物）。目的2 将使用混合方法收集有关干预措施影响的数据， 结果的解释和未来的实施。定性数据将提供有关 患者、提供者和卫生系统领导者的看法;定量数据将提供洞察力 干预应用、依从性、忠诚度和提供者信心。 该项目可以通过提供明确的和可推广的证据来改变LBP管理 关于解决身体和心理社会问题的一线非药物干预措施， 预防cLBP的因素。使用PT和DC使患者能够参与健康 疼痛管理行为，我们预期LBP相关的残疾，生产力损失，和依赖 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. 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 rising 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 are completing a novel randomized hybrid trial addressing both effectiveness and implementation. A total of 1000 patients have been 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 Medical Care (MC) 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 MC. Primary outcomes are prevention of cLBP at 12 months as measured by LBP Impact and average pain intensity and low back 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; quantitative data will offer insight on intervention application, adherence, fidelity, and provider confidence. This project can 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.