Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial
Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial
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DOI：
10.1186/s13063-018-2692-6
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发表时间：
2018-06-04
期刊：
影响因子：
2.5
通讯作者：
Kawchuk, Gregory
中科院分区：
文献类型：
--
作者：
Fritz, Julie M.;Sharpe, Jason A.;Kawchuk, Gregory
背景：腰痛是一种常见且昂贵的疾病。脊柱推拿疗法（SMT）是一种在一些指南中得到支持的治疗方法，尽管大多数研究SMT的临床试验报告的效应量很小。增强SMT的效果需要了解潜在的机制和系统的方法来利用对机制的理解，以创建在临床实践中可扩展的更有效的治疗方案。先前的工作已经确定了对脊柱刚度和腰椎多裂肌激活的影响作为可能的机制。该项目代表了一个多阶段优化策略（MOST）框架内的细化阶段研究。我们的目标是通过检查使用共同干预运动策略的影响来确定优化的SMT治疗方案，这些策略被提出来强调SMT机制。优化后的协议，然后可以在确认阶段的临床试验和实施study.Methods：一个阶段，析因随机试验设计将被用来评估三个干预组件提供了8个组合的机制（脊柱僵硬和多裂肌激活）和患者报告的结果（疼痛和残疾）的影响。所有受试者将接受两次治疗，然后在接下来的三周内随机分配接受六次额外治疗（或不接受额外治疗），并接受额外SMT和运动联合干预（脊柱动员和多裂肌激活）的因子组合。结果评估发生在基线、入组后1周、4周和3个月。预先指定的分析将评估治疗成分的主要影响，以及相互作用effects.Discussion：建立在初步研究结果确定可能的机制的影响SMT，这项试验代表了下一阶段的多阶段战略的最终目标，开发一个优化的协议，提供SMT与LBP患者。如果成功，这项试验的结果可以在未来的临床试验中进行测试，以产生更大的治疗益处，并改善LBP患者以患者为中心的结局。
Background: Low back pain is a common and costly condition. Spinal manipulative therapy (SMT) is a treatment supported in some guidelines, although most clinical trials examining SMT report small effect sizes. Enhancing the effects of SMT requires an understanding of underlying mechanisms and a systematic approach to leverage understanding of mechanisms to create more effective treatment protocols that are scalable in clinical practice. Prior work has identified effects on spinal stiffness and lumbar multifidus activation as possible mechanisms. This project represents a refinement phase study within the context of a multi-phase optimization strategy (MOST) framework Our goal is to identify an optimized SMT treatment protocol by examining the impact of using co-intervention exercise strategies that are proposed to accentuate SMT mechanisms. The optimized protocol can then be evaluated in confirmation phase clinical trials and implementation studies.Methods: A phased, factorial randomized trial design will be used to evaluate the effects of three intervention components provided in eight combinations on mechanistic (spinal stiffness and multifidus muscle activation) and patient-reported outcomes (pain and disability). All participants will receive two sessions then will be randomly assigned to receive six additional sessions (or no additional treatment) over the next three weeks with factorial combinations of additional SMT and exercise co-interventions (spine mobilizing and multifidus activating). Outcome assessments occur at baseline, and one week, four weeks, and three months after enrollment. Pre-specified analyses will evaluate main effects for treatment components as well as interaction effects.Discussion: Building on preliminary findings identifying possible mechanisms of effects for SMT, this trial represents the next phase in a multiphase strategy towards the ultimate goal of developing an optimized protocol for providing SMT to patients with LBP. If successful, the results of this trial can be tested in future clinical trials in an effort to produce larger treatment benefits and improve patient-centered outcomes for individuals with LBP.