Research Project

研究项目

• 批准号: 9898108
• 负责人: Daniel J Clauw
• 金额: $ 295.79万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898108
• 关键词: Acupressure; Acute; Address; Adult; Affect; American; Back; Back Pain; Behavior Therapy; Behavioral; Biological; Chronic; Chronic low back pain; Clinical; Clinical Treatment; Cognitive; Cognitive Therapy; Combination Medication; Complex; Coronary heart disease; Data; Development; Diabetes Mellitus; Diagnosis; Disease; Economic Factors; Elements; Enrollment; Etiology; Evidence based intervention; Evidence based treatment; Functional disorder; Goals; Image; Individual; Inflammation; Institute of Medicine (U.S.); Intervention; Left; Low Back Pain; Maintenance; Malignant Neoplasms; Measures; Mechanics; Medical; Michigan; Modeling; Monitor; Online Systems; Operative Surgical Procedures; Pain; Pain management; Participant; Patient Outcomes Assessments; Patients; Pelvis; Pharmaceutical Preparations; Pharmacology; Phenotype; Physical Examination; Physical therapy exercises; Plasma; Precision Medicine Initiative; Prediction of Response to Therapy; Prevalence; Problem Solving; Psychosocial Factor; Public Health; Quality of life; Questionnaires; Randomized; Reporting; Research; Research Design; Research Project Grants; Role; Sensory; Series; Structure; Symptoms; Testing; Universities; Virulence Factors; Visit; Work; aging population; base; biopsychosocial; chronic pain; chronic pain patient; clinical phenotype; cohort; cost; demographics; disability; duloxetine; experience; functional disability; functional restoration; gabapentin; mindfulness based cognitive therapy; neuroimaging; opioid epidemic; pain patient; pain relief; pragmatic trial; precision medicine; pregabalin; psychologic; randomized trial; reduce symptoms; relating to nervous system; response; self-management program; social; translational approach; treatment duration

PROJECT SUMMARY / ABSTRACT RESEARCH PROJECT The evidence-based treatments for cLBP typically include a combination of pharmacologic, non-pharmacologic and procedural treatments. However, none of these treatments works well in more than a fraction of patients, and at present there is little guidance regarding what treatment should be used in which patients (i.e. precision medicine). The BACPAC precision medicine initiative for cLBP will attempt to solve this problem by deeply phenotyping cLBP participants to identify the various underlying mechanisms causing cLBP. We feel that a critical element of such phenotyping is to also understand which participants respond to which therapies, so that we can then eventually choose the appropriate treatment for a cLBP patient based on which underlying mechanisms are contributing to their pain and dysfunction. Our central hypothesis in our BACPAC MRC Research Project is that an Interventional Response Phenotyping study can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for cLBP”. To address this hypothesis, we will conduct a randomized controlled SMART study of cLBP with the following three aims. The first aim is to perform an Interventional Response Phenotyping study in a cohort of cLBP patients. We will perform a pragmatic trial using a cohort of cLBP patients (n=500), who will receive a sequence of interventions known to be effective in cLBP. For 6 weeks, all cLBP participants will receive a web- based self-management program for pain. After six weeks, individuals who remain symptomatic will be enrolled in a Sequential, Multiple Assessment, Randomized Trial (SMART) design study and randomized to a series of treatments, including: a) mindfulness based cognitive therapy, b) physical therapy/exercise, c) acupressure, d) duloxetine, or e) pregabalin. After 12 weeks, individuals who remain symptomatic will be re-randomized to a different treatment for an additional 12 weeks. Having this information on all participants, we will overlay Aims 2 and 3, which will identify the subsets of participants that respond to each treatment. In Aim 2, we will show that currently available, clinically-derived measures, can predict differential responsiveness to the above therapies. In Aim 3, a subset of the individuals in Aims 1 and 2 will receive deeper phenotyping (n=200), to identify new experimental measures that predict differential responsiveness to each of the above therapies, as well as to infer mechanisms of action of treatments. These deep phenotyping visits take nearly an entire day each, will be performed prior to each treatment period and at the completion of the study, and will include functional neuroimaging, quantitative sensory testing, plasma measures of inflammation, and measures of autonomic tone.

项目摘要 /摘要 研究项目 CLBP的循证治疗通常包括药理学，非药物的结合 和程序治疗。但是，这些疗法在一小部分患者中都没有效果很好， 目前，关于使用哪种治疗方法的指导很少（即精度 药品）。 CLBP的BACPAC精确医学计划将尝试通过深入解决此问题 表型CLBP参与者确定导致CLBP的各种潜在机制。我们觉得一个 这种表型的关键要素也是要了解哪些参与者对哪种疗法做出反应，因此 然后，我们最终可以为CLBP患者选择适当的治疗方法 机制有助于其疼痛和功能障碍。我们在BACPAC MRC中的中心假设 研究项目是，一项介入反应表型研究可以识别患有不同的人 因此，痛苦的基本机制因此对基于证据的干预措施的反应不同 CLBP”。为了解决这一假设，我们将对CLBP进行随机对照的智能研究 以下三个目标。第一个目的是在一组中进行介入的反应表型研究 CLBP患者。我们将使用一群CLBP患者（n = 500）进行务实的试验，他们将接受 已知在CLBP有效的干预措施序列。在6周内，所有CLBP参与者都将获得网络 - 基于疼痛的自我管理计划。六个星期后，保持症状的人将被招募 在一项顺序的多次评估，随机试验（智能）设计研究中，并随机分为一系列 疗法，包括：a）基于正念的认知疗法，b）物理疗法/运动，c）穴位疗法，d） 杜洛西汀或e）前伽巴林。 12周后，保持症状的人将重新融合到 另外12周不同的治疗方法。拥有有关所有参与者的此信息，我们将覆盖目标 2和3，这将确定对每种治疗响应的参与者的子集。在AIM 2中，我们将显示 目前可用的临床措施可以预测上述的差异响应能力 疗法。在AIM 3中，AIM 1和2中的一个个体将接受更深入的表型（n = 200）， 确定新的实验措施，以预测上述每种疗法的差异反应，例如 以及推断治疗作用机制。这些深入的表型访问几乎需要一整天 每个，将在每个治疗期之前和研究完成时进行，并将包括 功能性神经影像学，定量感觉测试，炎症的血浆测量以及测量 自主基调。