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

项目总结 美国正处于一场前所未有的痛苦管理危机之中。指导方针有 推荐的非药物疗法，如脊柱手法和行为疗法 LBP的方法已经有近十年了，但接受度和坚持性一直很差。此外， 关于这些疗法在慢性下腰痛二级预防中的作用，人们知之甚少。 (CLBP)，特别是对于有生物、心理和社会危险因素的患者。随着成本的上升，不断增加 包括阿片类药物在内的常用药物治疗无效的证据和危害， 迫切需要研究预防慢性下腰痛的非药物治疗方法 可以很容易地转化为实践。 长期目标是通过测试可扩展、一线、非 针对急性/亚急性LBP的生物、心理和社会方面的药理学策略 防止过渡到cLBP。我们正在完成一项新的随机混合试验，解决这两个问题 有效性和执行力。共有1000名患者登记了非特异性 持续2-12周的LBP，有中高风险发生慢性LBP。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 脊柱手法疗法(SMT)、结构化自我管理(SSM)和SMT+SSM 使用2x2析因设计的随机试验中的相对于医疗保健(MC)。物理 治疗师(PT)和脊椎按摩师(DC)将提供SMT和SSM，以及初级保健临床医生 将交付MC。根据LBP的测量，主要结果是在12个月时预防慢性LBP 影响和平均疼痛强度和1年以上的腰部残疾。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)。目标2 将使用混合方法来收集有关可能影响 对结果的解释和今后的执行。定性数据将为以下方面提供背景 患者、提供者和卫生系统领导者的看法；量化数据将提供洞察力 关于干预应用、忠诚度、忠诚度和提供者的信心。 该项目可以通过提供确凿和普遍的证据来改变LBP管理 关于解决生理和心理社会问题的前线非药物干预 慢性下腰痛的预防因素。使用PTS和DC使患者能够从事健康 疼痛管理行为，我们预计会出现与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.