Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Int

评估两个不同的互补/整合中的特异性和非特异性机制

• 批准号: 10238857
• 负责人: Stephen Bruehl
• 金额: $ 76.16万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10238857
• 关键词: Acupuncture Therapy; Address; Affect; Attention; Categories; Chronic low back pain; Cognition; Data; Early treatment; Etiology; Integrative Therapy; Intervention; Knowledge; Link; Mindfulness Training; Moods; Outcome; Outcome Measure; Pain; Pain management; Patient Participation; Patients; Procedures; Proliferating; Public Health; Randomized; Research; Resources; Role; Science; Self Efficacy; Spinal; Spinal Manipulation; System; Testing; Theoretical model; Therapeutic; Time; Treatment Efficacy; Work; chronic pain; comparative; conditioned pain modulation; endogenous opioids; mindfulness; neglect; outcome prediction; pain catastrophizing; patient expectation; public health relevance; theories; treatment effect

Modified Project Summary/Abstract Section Chronic low back pain (CLBP) is a major public health concern. Complementary/integrative (C/I) chronic pain interventions have proliferated (eg, Mindfulness Training [MT], spinal manipulation therapy [SMT]), and some approaches have strong support for efficacy. Most research has focused on questions regarding treatment efficacy. However, important questions regarding treatment mechanisms have been neglected. A parsimonious approach to uncovering C/I treatment mechanisms may start from the hypothesis that C/I treatments work to a large extent via non-specific mechanisms that may be shared across treatments. Candidate non-specific mechanisms can be grouped into at least 3 categories: endogenous pain inhibitory systems (endogenous opioid function; conditioned pain modulation), pain-related cognition (pain catastrophizing; self-efficacy), and therapy factors (therapeutic relationship, patient expectations). The general hypothesis is that treatment-induced changes in these non-specific mechanisms will predict outcomes across different C/I interventions. At the same time, the contribution of specific mechanisms must be addressed. For MT, this would be changes in mindfulness, whereas for SMT, this would be changes in spinal stiffness. The proposed study will compare the degree to which MT and SMT activate specific and non-specific mechanisms, and the degree to which these mechanisms affect pain-related outcomes. Comparing the activation and effects of mechanisms in these 2 interventions in a single trial will allow us to test the degree to which effects of certain mechanisms are shared across treatments or are unique to a given treatment. 240 people with CLBP will be randomly assigned to MT, or SMT. All mechanism and outcome measures will be assessed frequently across all treatments. We expect the 2 treatments to produce significant changes in pain, mood and function. Aim 1 will test to what degree MT and SMT produce changes in non-specific mechanisms. Aim 2 will test to what degree MT and SMT produce changes in treatment-specific mechanisms (MT: mindfulness; SMT: spinal stiffness). Aim 3 will test to what degree changes in non-specific and specific mechanisms predict changes in pain, mood and function, and whether these relationships depend on the treatment received, and the degree to which changes in non-specific and specific mechanisms account for unique and shared variance in predicting outcomes. Addressing questions of mechanism is critical to the science and practice of C/I pain interventions because it: (1) tests theory validity, (2) provides empirically-supported rationale for asking people with pain to devote the resources needed to participate in treatment, (3) identifies the effective mechanisms of pain treatments and reveals those that may be redundant or inert, and (4) provides theoretical and empirical principles by which to enhance those C/I mechanisms that are most closely linked to the largest benefits.

修改的项目摘要/摘要部分 慢性腰痛（CLBP）是一个主要的公共卫生问题。互补/综合性（C/I）慢性疼痛干预措施已经增殖（例如，正念训练[MT]，脊柱操纵疗法[SMT]），某些方法对疗效有很大的支持。大多数研究都集中在有关治疗功效的问题上。但是，有关治疗机制的重要问题已被忽略。 揭示C/I治疗机制的一种简约的方法可能始于以下假设：C/I治疗在很大程度上通过非特异性机制起作用，这些机制可以在跨治疗中共享。候选非特异性机制可以至少分为3类：内源性疼痛抑制系统（内源性阿片类药物功能；条件疼痛调节），与疼痛相关的认知（疼痛灾难性；自我效能感）和治疗因素（治疗性关系，患者的期望）。一般假设是，治疗引起的这些非特异性机制的变化将预测不同C/I干预措施的结果。同时，必须解决特定机制的贡献。对于MT而言，这将是正念的变化，而对于SMT，这将是脊柱刚度的变化。拟议的研究将比较MT和SMT激活特定和非特异性机制的程度，以及这些机制影响与疼痛相关的结果的程度。比较一次试验中这两种干预措施中机制的激活和影响将使我们能够测试某些机制在跨处理中共享某些机制的影响或给定治疗方面所独有的。有240名CLBP的人将随机分配给MT或SMT。 所有机制和结果指标都将在所有治疗中经常评估。我们预计两种治疗方法会在疼痛，情绪和功能上产生重大变化。 AIM 1将测试MT和SMT在非特异性机制中产生变化的程度。 AIM 2将测试MT和SMT在多大程度上产生特定治疗特异性机制的变化（MT：正念； SMT：脊柱刚度）。 AIM 3将测试非特异性和特定机制的程度变化预测疼痛，情绪和功能的变化，以及这些关系是否取决于所接受的治疗，以及非特异性和特定机制的变化占预测结果中独特和共同的差异的程度。 解决机制问题对于C/I疼痛干预的科学和实践至关重要，因为它：（1）测试理论有效性，（2）为要求疼痛的人提供依据的理由，以专用于疼痛的人参与治疗所需的资源，（3）通过疼痛治疗的有效机制，并揭示那些可能具有繁荣的机制，并揭示那些可能是冗余或INERT或INERT和INERT和EM（4）和EM（4）和EM（4）的empir and，并且与最大收益最密切相关的机制。