Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, Athens, OH, United States; Department of Biomedical Sciences, Ohio University, Athens, OH, United States.
Ohio Musculoskeletal and Neurological Institute (OMNI), Ohio University, Athens, OH, United States; Division of Physical Therapy, School of Rehabilitation and Communication Sciences, Ohio University, Athens, OH, United States.
Contemp Clin Trials. 2018 Jul;70:41-52. doi: 10.1016/j.cct.2018.05.012. Epub 2018 May 21.
Low back pain (LBP) is one of the most common reasons for seeking medical care. Manipulative therapies are a common treatment for LBP. Few studies have compared the effectiveness of different types of manipulative therapies. Moreover, the physiologic mechanisms underlying these treatments are not fully understood. Herein, we present the study protocol for The Researching the Effectiveness of Lumbar Interventions for Enhancing Function Study (The RELIEF Study).
The RELIEF Study is a Phase II RCT with a nested mechanistic design. It is a single-blinded, sham-controlled study to test the mechanisms and effectiveness of two manual therapy techniques applied to individuals (n = 162; 18-45 years of age) with chronic LBP. The clinical outcome data from the mechanistic component will be pooled across experiments to permit an exploratory Phase II RCT investigating the effectiveness. Participants will be randomized into one of three separate experiments that constitute the mechanistic component to determine the muscular, spinal, and cortical effects of manual therapies. Within each of these experimental groups study participants will be randomly assigned to one of the three treatment arms: 1) spinal manipulation, 2) spinal mobilization, or 3) sham laser therapy. Treatments will be delivered twice per week for 3-weeks.
This data from this will shed light on the mechanisms underlying popular treatments for LBP. Additionally, the coupling of this basic science work in the context of a clinical trial will also permit examination of the clinical efficacy of two different types of manipulative therapies.
下背痛（LBP）是寻求医疗的最常见原因之一。手法治疗是 LBP 的常见治疗方法。很少有研究比较过不同类型的手法治疗的效果。此外，这些治疗的生理机制尚未完全了解。在此，我们介绍了研究增强功能的腰椎干预措施效果的研究方案（RELIEF 研究）。
RELIEF 研究是一项具有嵌套机制设计的 II 期 RCT。这是一项单盲、假对照研究，旨在测试两种应用于慢性 LBP 个体（n=162；18-45 岁）的手法治疗技术的机制和效果。机制部分的临床结果数据将在实验之间进行汇总，以允许对有效性进行探索性 II 期 RCT 研究。参与者将随机分为三个独立的实验机制部分，以确定手法治疗的肌肉、脊柱和皮质效应。在这些实验组中的每一个中，研究参与者将被随机分配到三个治疗组之一：1）脊柱推拿，2）脊柱松动术，或 3）假激光治疗。治疗将每周两次进行 3 周。
这项研究将阐明治疗 LBP 的常用方法的潜在机制。此外，在临床试验背景下结合这项基础科学工作，还将检验两种不同类型的手法治疗的临床疗效。
