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

预防急性至慢性背痛的脊柱手法和患者自我管理数据协调中心 (PACBACK)

• 批准号: 9923235
• 负责人: PATRICK J HEAGERTY
• 金额: $ 43.55万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9923235
• 关键词: Acute; Address; Adherence; Adult; Affect; Back; Behavior; Behavioral; Caring; Chronic; Chronic low back pain; Clinic; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Committee Members; Communication; Complementary Health; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Databases; Doctor of Philosophy; Documentation; Drug usage; Effectiveness; Electronic Mail; Enrollment; Future; Goals; Guidelines; Health Occupations; Healthcare; Hybrids; Individual; Integrative Medicine; Internet; Intervention; Leadership; Link; Low Back Pain; Manuals; Medical; Methodology; Methods; Monitor; Online Systems; Opioid; Overdose; Pain management; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase III Clinical Trials; Physical therapy; Preparation; Prevention; Primary Health Care; Principal Investigator; Protocols documentation; Provider; Psychosocial Factor; Public Health; Publications; Quality Control; Randomized; Recovery; Reporting; Research; Research Design; Research Personnel; Risk; Risk Factors; Role; Screening procedure; Secondary Prevention; Self Management; Site; Societies; Spinal Manipulation; Strategic Planning; Structure; Subgroup; System; Testing; Training; Translating; Translations; Universities; Washington; Work; addiction; base; biopsychosocial; care providers; chiropracty; chronic back pain; chronic pain; chronic painful condition; clinical practice; clinical research site; cost; design; disability; empowered; experience; high risk; implementation strategy; improved; nondrug therapy; novel; operation; opioid misuse; pain reduction; participant safety; performance site; prevent; primary outcome; productivity loss; public health priorities; randomized trial; secondary outcome; statistics; targeted treatment; tool; uptake; web site

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.

概括。美国正处于前所未有的疼痛管理危机之中。腰痛 (LBP) 是 成人最常见的慢性疼痛，也是全世界残疾的主要原因。指南有 推荐的非药物治疗方法，例如脊柱推拿和行为方法治疗 LBP 近十年来，但实践中的采用率一直很低。人们对这些治疗的作用知之甚少 慢性腰痛（cLBP）的二级预防，特别是对于具有生物心理社会危险因素的患者。和 cLBP 成本不断上升，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，迫切需要对 cLBP 的非药物治疗进行研究 预防措施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来减轻总体腰痛负担 解决急性/亚急性 LBP 的生物心理社会问题并防止向 cLBP 转变的策略。 我们提出了一项新颖的随机混合试验，解决有效性和实施问题。共 1180 个 将入组患有持续 2-12 周的非特异性腰痛、具有中度和高度发展风险的患者 cLBP 使用靶向治疗亚组 (STarT) 反向筛查工具 (SBST)。目标 1 将评估 脊柱手法治疗 (SMT)、结构化自我管理 (SSM) 和 SMT+SSM 的有效性 在使用 2x2 析因设计的随机试验中相对于常规医疗护理 (UMC)。主要结果是 12 个月时预防 cLBP； 6 个月时急性/亚急性腰痛恢复；和累计减少 疼痛和残疾超过一年。次要结果包括 PROMIS-29、生产力损失、医疗保健使用、 和药物使用（包括阿片类药物）。目标 2：将使用混合方法收集重要数据 对可能影响结果解释和未来实施的干预措施的影响。 与国家补充和综合健康中心 (NCCIH) 2016 年战略计划保持一致，本 该项目有潜力通过提供明确且可推广的方法来显着改变 LBP 管理 有关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 预测腰痛相关的残疾、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）将会减少。全面的传播和实施战略， 主要利益攸关方的共同努力将有助于转化为卫生专业的临床实践。