Biomechanical and Neurophysiological Effects of Spinal Manipulative Therapy

描述(申请人提供)：脊柱手法疗法(SMT)是一种常见的治疗腰背痛(LBP)的方法，有证据表明它对一些患者有治疗效果。尽管SMT的普遍使用和益处的证据，其潜在的治疗效果的机制还不是很清楚。目前的理论主要集中在SMT引起的生物力学和神经生理学变化作为可能的机制，但这些变化在LBP患者中还没有得到充分的研究，先前的研究也没有检验这些变化与SMT治疗反应的关系。将生物力学和神经生理学变化与患者的治疗反应联系起来，是将SMT的治疗机制与单纯的表面现象区分开来的必要步骤。这项研究汇集了一支在SMT的生物力学和神经生理学反应以及治疗结果测量方面经验丰富的研究团队。在收集数据之前，将对测量程序进行培训和标准化。然后将招募两组患有LBP的受试者；一组根据研究人员先前制定的临床预测规则被确定为可能的SMT应答者；另一组被确定为可能的无应答者。应答者队列中的受试者将随机接受SMT或对照组。无应答队列中的受试者将接受SMT。包括神经生理学和生物力学特征以及各种临床结果在内的一系列测试将在每次SMT治疗之前和之后直接进行评估。最后的重新评估将在最后的SMT治疗后一周进行，以检查持续的神经生理学和/或生物力学变化。这项研究的主要目的是比较两种SMT治疗成功和失败的受试者在SMT治疗后即刻的神经生理学和生物力学特征的变化。我们假设，成功受试者身上发生的变化与不成功受试者身上发生的变化不同。这项研究的次要目标是：1)比较两种SMT治疗成功或失败的受试者的神经生理学和生物力学特征的持续变化(1周)。我们假设，成功受试者身上发生的持续变化与不成功受试者身上发生的变化不同。2)基于预测规则，将被识别为可能的应答者或无应答者的受试者的基线(治疗前)特征与SMT进行比较。我们假设，在应用SMT治疗之前，不同组之间将观察到差异。3)根据预测规则，比较随机接受或不接受SMT的可能对SMT有反应的受试者的神经生理和生物力学特性的变化。我们假设接受SMT的受试者将表现出更大的变化。这项研究的结果将有助于将重点放在SMT潜在的机制上，这些机制与使用有效的测量程序的治疗反应有关。与公共卫生相关：下腰痛是一种常见的疾病，导致社会和受影响个人的高成本和残疾。手法是一种经常用于治疗下腰痛的疗法，尽管一些人从这种疗法中受益，但手法为什么有效目前尚不清楚。我们将检查对手法的神经生理学和生物力学反应以及患者的治疗反应，以帮助确定手法治疗效果的最相关机制。

DESCRIPTION (provided by applicant): Spinal manipulative therapy (SMT) is a common treatment for patients with low back pain (LBP) with evidence that it provides therapeutic benefit for some patients. Despite common use and evidence of benefit, mechanisms underlying the therapeutic effects of SMT are not well understood. Current theories focus on biomechanical and neurophysiologic changes produced by SMT as possible mechanisms, but these changes have not been sufficiently studied in patients with LBP, and prior research has not examined these changes in relation to the therapeutic response to SMT. Relating biomechanical and neurophysiologic changes to a patient's therapeutic response is a necessary step to separate therapeutic mechanisms of SMT from mere epiphenomena. This study assembles a team of investigators with experience in the measurement of biomechanical and neurophysiologic responses to SMT as well as therapeutic outcomes. Training and standardization of measurement procedures will be performed prior to data collection. Two cohorts of subjects with LBP will then be recruited; one identified as likely SMT responders based on a clinical prediction rule previously developed by the Investigators; the other identified as likely non-responders. Subjects in the responder cohort will be randomized to receive SMT or a control group. Subjects in the non-responder cohort will receive SMT. A battery of tests including neurophysiologic and biomechanical characteristics, and various clinical outcomes will be assessed before and directly after each SMT treatment. Final re-assessment will occur 1 week after the final SMT treatment to examine sustained neurophysiologic and/or biomechanical changes. The primary aim of the study is to compare immediate post-SMT changes in neurophysiologic and biomechanical characteristics between subjects who achieve therapeutic success or non-success with 2 SMT treatments. We hypothesize that changes occurring in successful subjects will differ from those occurring in non-successful subjects. Secondary aims of the study are; 1) compare sustained (1-week) changes in neurophysiologic and biomechanical characteristics between subjects who achieve therapeutic success or non-success with 2 SMT treatments. We hypothesize sustained changes occurring in successful subjects will differ from those occurring in non-successful subjects. 2) compare baseline (pre-treatment) characteristics of subjects identified as likely responders or non-responders to SMT based on the prediction rule. We hypothesize that differences will be observed between groups prior to the application of SMT treatment. 3) compare changes in neurophysiologic and biomechanical characteristics between subjects likely to respond to SMT based on the prediction rule who are randomized to receive or not receive SMT. We hypothesize subjects receiving SMT will demonstrate greater change. The results of this study will help to focus future research on mechanisms underlying SMT that are related to the therapeutic response to the treatment using validated measurement procedures. PUBLIC HEALTH RELEVANCE: Low back pain is a common condition resulting in high costs and disability for society and affected individuals. Manipulation is a treatment frequently used to treat low back pain, and although some individuals benefit from the treatment, why manipulation works is presently not known. We will examine neurophysiologic and biomechanical responses to manipulation along with the therapeutic response of the patient to help to determine the most relevant mechanisms underlying the therapeutic effects of manipulation.