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)

基本信息

批准号：
10226960
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
项目类别：
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/10226960
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 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 data quality design disability dissemination strategy effectiveness evaluation effectiveness implementation study empowered experience high risk implementation strategy improved nondrug therapy novel operation opioid misuse pain chronification 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

项目摘要

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状况和全球残疾的主要原因。指南有推荐的非药物治疗方法，例如脊柱操纵和LBP的行为方法将近十年的时间，在实践中的吸收还是很差。这些治疗的作用知之甚少在慢性LBP（CLBP）的二次预防中，特别是对于具有生物心理社会危险因素的患者。和 CLBP的迅速成本和无效性和常用药物危害的越来越多的证据包括阿片类药物在内的治疗方法对CLBP的非药物治疗的研究至关重要可以容易转化为实践的预防。长期目标是通过测试可扩展的一线非药物来减轻总体LBP负担解决急性/亚急性LBP的生物心理社会方面并防止过渡到CLBP的策略。我们提出了一项新型的随机混合试验，以解决有效性和实施。总共1180 患者将在中等和高风险中招募2-12周的非特异性LBP。 CLBP使用亚组进行靶向治疗（Start）背部筛选工具（SBST）。 AIM 1将评估脊柱操纵疗法（SMT），结构化自我管理（SSM）和SMT+SSM的有效性在使用2x2阶乘设计的随机试验中，相对于通常的医疗保健（UMC）。主要结果是预防12个月的CLBP； 6个月时从急性/急性LBP中恢复；和累积减少疼痛和残疾1年。次要结果包括Promis-29，生产力损失，医疗保健使用，和用药（包括阿片类药物）。目标2：将使用混合方法收集有关重要的数据影响可能影响结果解释和未来实施的干预措施。与国家补充和综合健康中心（NCCIH）2016年的战略计划一致，项目有可能通过提供确定且可推广的确定性来改变LBP管理关于针对身体和社会心理因素的一线非药物干预措施的证据用于预防CLBP。通过授权患者从事健康的疼痛管理行为，我们预期LBP相关的残疾，生产力损失以及对继续医疗保健和药物使用的依赖（包括阿片类药物）将减少。通知的全面传播和实施策略主要利益相关者将促进整个卫生专业的临床实践转化。