The RELIEF Study

修订后的摘要： 此申请是为了响应计划公告 PA-10-209“手法治疗生物学”。NIH 已认识到腰痛 (LBP) 是一个重大的健康问题，并且对该疾病最流行的治疗方法之一（即手法治疗）的机制研究非常缺乏。 背痛在医疗费用、残疾和个人痛苦方面对我们的社会产生了惊人的负面影响。 根据最近的一项全国调查，2007 年有超过 1800 万 18 岁以上的美国人接受了手法治疗，每年自付费用总计 39 亿美元。 脊柱手法治疗可大致分为基于手法或基于动员的技术。 基于操纵的技术（例如平移推力）向脊柱施加高速、低幅度的力，并且通常伴随着一个或多个关节发出的可听见的声音。相比之下，基于动员的技术（例如肌肉能量）使用低速、低力的方法，通常不会产生可听见的关节声音。虽然越来越多的证据表明手法疗法治疗腰痛的临床有效性，但人们对基于手法或基于活动的治疗的生理后果和效果知之甚少。此外，需要额外的数据来了解这些不同的手法治疗技术如何影响疼痛和残疾的临床变化。因此，我们提出一项研究者盲法、假对照研究，以测试两种手法治疗技术应用于慢性腰痛患者的机制和有效性。具体来说，RELIEF研究（研究腰椎干预措施增强功能的有效性研究）是一项具有嵌套机制设计的探索性II期随机临床试验（RCT）。 因此，这项研究有两个主要目标。 一是确定这两种常用于治疗慢性腰痛的手法治疗干预措施的生物学机制。 第二个是进行探索性随机对照试验，以确定这两种徒手疗法在减轻慢性腰痛患者的疼痛和残疾方面的有效性，并与彼此以及假对照组进行比较。患有慢性腰痛的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，或 3) 假超声治疗（n=54/治疗组）。 治疗每周两次，持续 3 周。在每个治疗组中，研究参与者将被随机分配到三个生理结果组之一，以确定手法治疗对肌肉、脊柱和皮质的影响。治疗干预措施将每周进行两次，持续 3 周。参与者将在基线、初次治疗干预后立即、48 小时和最后一次治疗干预后 1 个月接受评估。拟议的实验将在探索性 II 期随机对照试验设计中，对治疗 LBP 的两种最流行的手法疗法的肌肉、脊柱和皮质机制进行系统评估。

Revised Abstract: This application is in response to program announcement PA-10-209 ¿Biology of Manual Therapies.¿ The NIH has recognized that low back pain (LBP) is a significant health problem and that there is a tremendous lack of mechanistic studies on one of the most popular treatments for this disorder (i.e., manipulation treatment). Back pain has a staggeringly negative impact on our society in terms of medical expenses, disability, and individual suffering. According to a recent national survey, more than 18 million Americans over the age of 18 years received manipulative therapies in 2007 at a total annual out of pocket cost of $3.9 billion. Spinal manipulative treatments can be broadly classified as manipulation-based or mobilization-based techniques. Manipulation-based techniques (e.g., translatory thrust) apply a high-velocity, low-amplitude force to the spine and are often accompanied by an audible sound from one or more joints. In contrast, mobilization-based techniques (e.g., muscle energy) use a low-velocity, low-force approach that generally does not produce audible joint sounds. While there is growing evidence for the clinical effectiveness of manipulative therapies to treat low back pain, little is known on the physiologic consequences and effects of either manipulation-based or mobilization-based treatments. Further, addition data are needed to understand how these different manual therapy techniques effect clinical changes in pain and disability. Accordingly, we propose an investigator-blinded, sham-controlled study to test the mechanisms and effectiveness of two manual therapy techniques applied to individuals with chronic low back pain. Specifically, the RELIEF Study (Researching the Effectiveness of Lumbar Interventions for Enhancing Function Study) is an exploratory Phase II randomized clinical trial (RCT) with a nested mechanistic design. As such, there are two major goals of this study. One is to determine the biological mechanisms of these two manual therapy interventions commonly used in the treatment of chronic low back pain. The second is to conduct an exploratory RCT determine the effectiveness of these two manual therapies at reducing pain and disability in patients with chronic low back pain compared to each other as well as a sham control group. Participants with chronic low back pain will be randomly assigned to one of the three treatment arms: 1) spinal manipulation, 2) spinal mobilization, or 3) sham ultrasound therapy (n=54/treatment arm). Treatments will be delivered twice per week for 3-weeks. Within each treatment arm, study participants will be randomly assigned to one of three physiological outcome groups to determine the muscular, spinal, and cortical effects of manual therapies. Treatment interventions will be delivered twice per week for 3-weeks. Participants will be assessed at baseline, immediately after their initial treatment intervention, 48 hours, and 1 month after the last treatment intervention. The proposed experiments will provide a systematic assessment of the muscular, spinal, and cortical mechanisms of two of the most popular manual therapies for the treatment of LBP within an exploratory Phase II RCT design.