Spinal Manipulation and Patient Self-Management to Prevent Back Pain Chronicity

脊柱手法和患者自我管理可预防慢性背痛

基本信息

批准号：
10463642
负责人：
Gert Bronfort
金额：
$ 112.45万
依托单位：
UNIVERSITY OF MINNESOTA
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 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10463642
关键词：
Acute Address Adherence Adult Advisory Committees Affect American Back Behavior Behavioral Caring Chiropractor Chronic Chronic low back pain Data Data Collection Data Set Diabetes Mellitus Dissemination and Implementation Drug usage Effectiveness Elements Enrollment Future Group Meetings Guidelines Health Occupations Health system Healthcare Heart Diseases Hybrids Information Systems Intervention Low Back Pain Malignant Neoplasms Measurement Measures Mediator of activation protein Medical Methods National Center for Complementary and Integrative Health Numeric Rating Scale Opioid Overdose Pain Pain management Patient Outcomes Assessments Patients Perception Pharmaceutical Preparations Pharmacotherapy Prevention Primary Health Care Provider Psychosocial Factor Public Health Questionnaires Randomized Recovery Research Research Design Risk Factors Role Screening procedure Secondary Prevention Self Management Site Societies Specific qualifier value Spinal Manipulation Strategic Planning Structure Subgroup Testing Translating Translations United States National Institutes of Health addiction biopsychosocial chronic back pain chronic pain chronic painful condition cost design disability effectiveness evaluation evidence based guidelines experience future implementation high risk improved insight intervention delivery multidisciplinary nondrug therapy novel opioid misuse pain reduction pain-related disability phase III trial physical therapist prevent primary outcome productivity loss psychosocial public health priorities randomized trial secondary outcome targeted treatment uptake

项目摘要

PROJECT 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, 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 burgeoning 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 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 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 Usual Medical Care (UMC) 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 UMC. 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, 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 of barriers and facilitators; quantitative data collection will offer insight into intervention application, adherence, fidelity, and provider confidence. Aligned with the National Center for Complementary and Integrative Health's (NCCIH) Strategic Plan 2016, this project can 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. 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.

项目摘要美国正处于前所未有的疼痛管理危机之中。腰痛（LBP）是最常见的成人的慢性疼痛状况和全球残疾的主要原因。指南建议非药物治疗等非药物治疗，例如近十年LBP的脊柱操纵和行为方法，然而，吸收和依从性很差。而且，这些治疗的作用知之甚少慢性LBP（CLBP）的次要预防，特别是对于具有生物心理社会风险因素的患者。和蓬勃发展的成本，越来越多的效果证据以及常用药物治疗的伤害，包括阿片类药物包括对CLBP预防的非药物治疗的研究至关重要可以很容易地将其转化为实践。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 患者将在持续时间为2-12周的非特异性LBP，在中等或高风险的情况下 CLBP。这项多站点，主要是务实的第三阶段试验具有两个主要目的。 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）。物理治疗师（PT）和脊医（DC）将提供SMT和SSM，初级保健临床医生将提供UMC。基本的结果是预防12个月时CLBP； 6个月时从急性/急性LBP中恢复；和累积减轻1年的疼痛和残疾。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）。 AIM 2将使用混合方法收集有关影响可能影响结果解释和未来实施的干预措施。定性数据将为患者，提供者和卫生系统领导者对障碍和卫生系统领导者的看法提供有关障碍和卫生系统领导者的背景促进者；定量数据收集将洞悉干预应用程序，依从性，忠诚度和提供者的信心。与国家补充和综合健康中心（NCCIH）2016年的战略计划一致该项目可以通过提供确定且可推广的证据来大大改变LBP管理关于一线，非药物干预措施，解决了针对身体和社会心理因素的预防CLBP。使用PT和DCS授权患者进行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医疗保健和依赖使用药物（包括阿片类药物）将减少。