Optimization of Spinal Manipulative Therapy (SMT) Protocols

项目总结 腰背痛(LBP)是一种常见且代价高昂的疾病。脊柱手法治疗(SMT)是一种 对腰痛患者进行常见的心身干预。尽管LBP的SMT已经 在大量的临床研究中，有关SMT的文献仍然不清楚甚至不清楚。 关于这种治疗的有效性是相互矛盾的。支持SMT的研究有 一般发现治疗效果相对较小。人们提出了许多理由来解释为什么 研究文献不一致，SMT的效应大小较小。提供的一个主要理由是 临床研究中使用的SMT方案并不是最优的，主要是由于缺乏 理解通过以下途径实现SMT临床益处的潜在机制 一些LBP患者。 这个研究小组之前的工作已经确定了两种解释治疗的机制 SMT的影响。这些影响是脊柱僵硬的减少和改善的激活 腰椎多裂肌。我们的研究团队还开发出了准确的、非侵入性的 测量这些效应的方法及其对SMT的反应。我们的模型确定了这两个 机制已在第二个患者样本中得到验证。 我们在这项提案中的总体目标是优化LBP患者的SMT治疗方案。 我们的优化策略将评估SMT与其他已知的调节治疗相结合 SMT临床效果的基础信号是评估机械性(僵硬， 腰椎多裂激活)和以患者为中心(功能和疼痛)的结果。在这个项目中 我们将使用创新的方法来有效地评估各种个人的效果 针对总体效果的治疗组件；确定哪些组件起作用 目标结果，如果有的话，可能会被丢弃。我们将提供两个SMT会议 致所有参与者。然后，我们将按应答者状态分层随机选择受试者进行治疗 使用析因设计评估不同的组合 干预部分(肌肉激活练习、脊柱动员练习、其他 SMT)，在相同的通路上工作，调节相同的效果(脊柱僵硬和 肌肉激活)。结果将包括脊柱僵硬和肌肉激活措施，如 以及在基线以及1周、4周和3周后评估的患者报告的结果 月份。该项目的结果将提供优化的SMT协议，将准备 在未来随机对照试验中的应用 SMT。

PROJECT SUMMARY Low back pain (LBP) is a common and costly condition. Spinal manipulative therapy (SMT) is a common mind body intervention for individuals with LBP. Although SMT for LBP has been examined in numerous clinical studies, the literature on SMT remains unclear and even contradictory as to the effectiveness of this treatment. Studies that have supported SMT have generally found relatively small treatment effects. Many reasons have been offered for the inconsistent research literature and small effect sizes of SMT. A primary rationale offered is that the SMT protocols used in clinical research are not optimal, primarily due to a lack of understanding of the underlying mechanisms explaining the clinical benefits of SMT realized by some patients with LBP. The prior work of this research team has identified two mechanisms explaining the therapeutic effects of SMT. These effects are a reduction in spinal stiffness and improved activation of the lumbar multifidus muscle. Our research team has also developed accurate, non-invasive methods to measure these effects and their response to SMT. Our model identifying these two mechanisms has been validated in a second patient sample. Our overall goal in this proposal is to optimize SMT treatment protocols for patients with LBP. Our optimization strategy will evaluate SMT combined with other treatments known to modulate the same signals that underlie the clinical effects of SMT assessing both mechanistic (stiffness, lumbar multifidus activation) and patient-centered (function and pain) outcomes. In this project we will use innovative methodology to efficiently evaluate the effects of various individual treatment components towards an overall effect; identifying which components are contributing to the target outcomes and which, if any, may be discarded. We will provide 2 sessions of SMT to all participants. We will then randomize subjects stratified by responder status to a treatment group for an additional 3 weeks using a factorial design to evaluate different combinations of intervention components (muscle activation exercise, spinal mobilizing exercise, additional SMT) that work on the same pathways that modulate the same effects (spinal stiffness and muscle activation). Outcomes will include spinal stiffness and muscle activation measures as well as patient-reported outcomes assessed at baseline, and after 1 week, 4 weeks and 3 months. Results of this project will provide optimized SMT protocols that will be ready for application in future randomized controlled trials examining the efficacy and effectiveness of SMT.