Optimization of Spinal Manipulative Therapy (SMT) Protocols

脊柱手法治疗 (SMT) 方案的优化

• 批准号: 9206061
• 负责人: Julie M Fritz
• 金额: $ 39.61万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9206061
• 关键词: Area; Biological Phenomena; Biomechanics; Characteristics; Clinical; Clinical Research; Clinical Trials; Development; Effectiveness; Exercise; Future; Goals; Individual; Intervention; Literature; Low Back Pain; Measurement; Measures; Methodology; Methods; Mind-Body Intervention; Modeling; Muscle; Outcome; Pain; Participant; Pathway interactions; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Physiological; Placebos; Population; Procedures; Protocols documentation; Randomized; Randomized Controlled Trials; Reporting; Research; Sampling; Signal Transduction; Spinal; Spinal Manipulation; Therapeutic Effect; Treatment Effectiveness; Treatment Protocols; Treatment outcome; Work; base; clinical effect; design; improved; improved functioning; innovation; muscle stiffness; patient oriented; randomized trial; response; systematic review; treatment effect; treatment group; treatment responders

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.

项目概要 腰痛 (LBP) 是一种常见且昂贵的疾病。脊柱手法治疗（SMT）是一种 对 LBP 患者进行常见的身心干预。尽管 LBP 的 SMT 已 经过大量临床研究的检验，关于 SMT 的文献仍然不清楚，甚至 对于这种治疗的有效性存在矛盾。支持 SMT 的研究有 一般发现治疗效果比较小。对此，人们提出了很多理由 研究文献不一致且 SMT 效应较小。提供的一个主要理由是 临床研究中使用的 SMT 协议并不是最佳的，主要是由于缺乏 了解解释 SMT 临床益处的根本机制 一些腰痛患者。 该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。这些效果是减少脊柱僵硬并改善脊柱的激活 腰多裂肌。我们的研究团队还开发了准确、非侵入性的 衡量这些影响及其对 SMT 的响应的方法。我们的模型识别这两个 机制已在第二个患者样本中得到验证。 我们本提案的总体目标是优化 LBP 患者的 SMT 治疗方案。 我们的优化策略将评估 SMT 与其他已知调节治疗方法的结合 SMT 评估机械（刚度、 腰椎多裂肌激活）和以患者为中心的（功能和疼痛）结果。在这个项目中 我们将使用创新的方法来有效评估各种个人的影响 治疗成分以达到整体效果；确定哪些组件正在发挥作用 目标结果，如果有的话，可能会被丢弃。我们将提供2次SMT 致所有参与者。然后，我们将根据治疗反应者状态对受试者进行随机分层 使用因子设计再进行 3 周的分组，以评估不同的组合 干预组成部分（肌肉激活练习、脊柱动员练习、额外的 SMT）作用于调节相同效应（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 以及患者报告的基线、1 周、4 周和 3 周后评估的结果 几个月。该项目的成果将提供优化的 SMT 协议，以便为 在未来检验功效和有效性的随机对照试验中的应用 SMT。