The RELIEF Study

修订摘要： 这项申请是对PA-10-209？手动疗法生物学的回应。美国国立卫生研究院已经认识到下腰痛(LBP)是一个严重的健康问题，而且对这种疾病最流行的治疗方法之一(即手法治疗)的机械学研究非常缺乏。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令人震惊的负面影响。根据最近的一项全国调查，2007年，超过1800万18岁以上的美国人接受了手法治疗，每年自掏腰包的总费用为39亿美元。脊柱手法治疗大致可分为基于手法的技术或基于活动的技术。基于手法的技术(例如，平移推力)对脊柱施加高速、低幅度的力，并经常伴随从一个或多个关节发出的可听到的声音。相比之下，基于运动的技术(例如肌肉能量)使用的是一种低速、低力的方法，通常不会产生可听到的关节声音。虽然越来越多的证据表明手法疗法治疗下腰痛的临床有效性，但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，还需要更多的数据来了解这些不同的手动治疗技术如何影响疼痛和残疾的临床变化。因此，我们提出了一项研究人员盲法、假对照研究，以测试两种手法治疗慢性下腰痛患者的机制和有效性。具体地说，缓解研究(研究腰椎干预措施的有效性以增强功能研究)是一项嵌套机械设计的探索性第二阶段随机临床试验(RCT)。因此，这项研究有两个主要目标。一是确定这两种手法干预治疗慢性下腰痛的生物学机制。第二项是进行探索性随机对照试验，确定这两种手法在减轻慢性下腰痛患者疼痛和残疾方面的有效性，并与假对照组进行比较。患有慢性下腰痛的参与者将被随机分配到三个治疗组中的一个：1)脊柱手法，2)脊柱松动术，或3)假超声波治疗(n=54/治疗组)。治疗将每周提供两次，为期3周。在每个治疗臂中，研究参与者将被随机分配到三个生理结果组中的一个，以确定手动治疗的肌肉、脊髓和皮质效应。治疗干预措施将每周提供两次，为期3周。参与者将在基线、最初治疗干预后立即、48小时和最后一次治疗干预后1个月进行评估。拟议的实验将在探索性的II期随机对照试验设计中，对两种最受欢迎的治疗LBP的手动疗法的肌肉、脊髓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.