Optimization of Spinal Manipulative Therapy (SMT) Protocols

脊柱手法治疗 (SMT) 方案的优化

• 批准号: 9321393
• 负责人: Julie M Fritz
• 金额: $ 39.75万
• 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/9321393
• 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; Subgroup; Therapeutic Effect; Therapeutic Intervention; Treatment Effectiveness; Treatment Protocols; Treatment outcome; Work; base; clinical effect; cost; design; improved; improved functioning; innovation; multi-component intervention; 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.

项目摘要 下背痛（LBP）是一种常见且昂贵的疾病。脊柱推拿疗法（SMT）是一种 对LBP患者进行常见的身心干预。虽然LBP的SMT已经 在众多的临床研究中，关于SMT的文献仍然不清楚，甚至 这种治疗方法的有效性是矛盾的。支持SMT的研究有 通常发现相对较小的治疗效果。许多原因已经提出了 不一致的研究文献和SMT的小效应量。提供的主要理由是 临床研究中使用的SMT方案不是最佳的，主要是由于缺乏 理解解释SMT临床获益的潜在机制， 一些LBP患者。 该研究小组先前的工作已经确定了两种解释治疗作用的机制。 SMT的影响。这些效果是脊柱僵硬度的降低和增强了 腰多裂肌我们的研究团队还开发了准确的，非侵入性的 方法来衡量这些影响及其对SMT的反应。我们的模型识别出这两个 机制已在第二患者样本中得到验证。 我们的总体目标是优化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 作为SMT临床效果的基础的相同信号评估两种机制（刚度， 腰椎多裂肌激活）和以患者为中心（功能和疼痛）的结局。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影响， 治疗成分对整体效果的影响;确定哪些成分起作用 目标结果，如果有的话，可以被丢弃。我们将提供2节SMT 所有参与者。然后，我们将按应答者状态分层的受试者随机分配至治疗组 使用析因设计再分组3周，以评价不同的 干预成分（肌肉激活锻炼、脊柱活动锻炼、额外的 SMT），其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， 以及基线时以及1周、4周和3周后评估的患者报告结局 个月该项目的结果将提供优化的SMT协议， 在未来的随机对照试验中的应用， SMT。