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

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 成人最常见的慢性疼痛状况，也是全球残疾的主要原因。准则 推荐的非药物治疗，如脊柱推拿和行为方法治疗腰痛， 然而，近十年来，在实践中的吸收一直很差。人们对这些治疗的作用知之甚少 在慢性LBP（cLBP）的二级预防中，特别是对于具有生物心理社会危险因素的患者。与 cLBP的成本迅速上升，越来越多的证据表明常用药物无效和有害 治疗，包括阿片类药物，对cLBP的非药物治疗的研究是迫切需要的 预防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非药物治疗， 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，这些患者具有中度和高度的发展风险。 cLBP使用靶向治疗亚组（STarT）回筛工具（SBST）。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。主要结局 在12个月时预防cLBP;在6个月时从急性/亚急性LBP恢复;以及 疼痛和残疾超过1年。次要结局包括PROMIS-29、生产力损失、医疗保健使用， 药物使用（包括阿片类药物）。目标2：将使用混合方法收集有关重要 对干预措施的影响，可能会影响结果的解释和未来的实施。 根据国家补充和综合健康中心（NCCIH）2016年战略计划， 该项目有可能通过提供明确的和可推广的LBP管理， 关于解决身体和心理社会因素的一线非药物干预措施的证据 用于预防cLBP。通过让患者参与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和药物使用的依赖 （包括阿片类药物）将减少。全面传播和执行战略， 由主要利益攸关方提供的信息，将有助于转化为跨卫生专业的临床实践。

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, however uptake in practice has been poor. Little is known about the role of these treatments in secondary prevention of chronic LBP (cLBP), especially for patients with biopsychosocial risk factors. With burgeoning costs of cLBP and 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 and high risk of developing cLBP using the Subgroups for Targeted Treatment (STarT) Back Screening Tool (SBST). 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. 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, health care use, and medication use (including opioids). Aim 2: will use mixed methods to gather data about important influences on the interventions that could affect results interpretation and future implementation. Aligned with the National Center for Complementary and Integrative Health's (NCCIH) Strategic Plan 2016, this project has the potential to 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. By empowering patients to engage in healthy pain management behaviors, we anticipate LBP related disability, productivity loss, and reliance on continued health care and medication use (including opioids) will be reduced. The comprehensive dissemination and implementation strategy, informed by major stakeholders, will facilitate translation into clinical practice across health professions.