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.

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 成人最常见的慢性疼痛状况，也是全球残疾的主要原因。指导方针有 推荐的非药物治疗，如脊柱手法和LBP的行为方法 然而，近十年来，人们在实践中的理解一直很差。人们对这些疗法的作用知之甚少。 在慢性下腰痛(CLBP)的二级预防中，尤其是对有生物、心理、社会危险因素的患者。使用 CLBP费用的迅速增长和越来越多的证据表明常用药物的无效和危害 治疗，包括阿片类药物，迫切需要研究慢性下腰痛的非药物治疗方法 可以很容易地转化为实践的预防。 长期目标是通过测试可扩展的一线非药物来减少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处于中等或高度水平。 CLBP采用亚组靶向治疗(START)背向筛查工具(SBST)。目标1将评估 脊柱手法疗法(SMT)、结构化自我管理(SSM)和SMT+SSM的疗效比较 使用2x2析因设计的随机试验中的相对于常规医疗(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；以及累积减少 疼痛和残疾1年以上。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有关重要信息的数据 对可能影响结果解释和未来执行的干预措施的影响。 与国家补充和综合健康中心(NCCIH)2016年战略计划保持一致，这 项目有可能显著改变LBP管理，因为它提供了明确和通用的 关于针对生理和心理社会因素的一线非药物干预的证据 用于预防慢性腰背痛。通过让患者参与健康的疼痛管理行为，我们 预计与LBP相关的残疾、生产力损失以及对持续的医疗保健和药物使用的依赖 (包括阿片类药物)将减少。全面传播和实施战略，知情 主要利益攸关方的合作，将促进将其转化为卫生专业的临床实践。