The RELIEF Study

救济研究

• 批准号: 8538295
• 负责人: Brian C Clark
• 金额: $ 35.75万
• 依托单位: OHIO UNIVERSITY ATHENS
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8538295
• 关键词: 18 year old; Acute; Affect; American; Attenuated; Automobile Driving; Back Pain; Biological; Biology; Blinded; Chronic low back pain; Clinical Trials Design; Clinical effectiveness; Community Healthcare; Control Groups; Data; Development; Disease; Effectiveness; Feedback; Functional Magnetic Resonance Imaging; Goals; Health; Hour; Hyperactive behavior; Imaging Techniques; Individual; Intervention; Joints; Knowledge; Low Back Pain; Magnetic Resonance Imaging; Manipulative Therapies; Manuals; Mediating; Medical; Modeling; Motor Cortex; Motor Neurons; Movement; Muscle; Muscle Spindles; NIH Program Announcements; Nociception; Nociceptive Stimulus; Outcome; Pain; Participant; Pathology; Patients; Phase; Physicians; Physiologic pulse; Physiological; Process; Randomized; Randomized Clinical Trials; Reflex action; Research Personnel; Rest; Signal Transduction; Societies; Spasm; Spinal; Spinal Manipulation; Stretching; Surface; Surveys; Techniques; Testing; Therapeutic Intervention; Transcranial magnetic stimulation; Ultrasonic Therapy; Ultrasonography; United States; United States National Institutes of Health; Vertebral column; Visit; Work; abstracting; arm; base; clinical effect; cost; design; disability; effectiveness research; improved; innovation; kinematics; research study; response; sham-controlled study; sound; spinal reflex; spine bone structure; stretch reflex

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.

修订摘要： 此应用程序是在响应程序公告PA-10-209 <$手动治疗生物学<$。 NIH已经认识到腰痛（LBP）是一个重要的健康问题，并且非常缺乏对这种疾病最流行的治疗方法之一的机制研究（即，操作处理）。 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性调查，2007年有超过1800万18岁以上的美国人接受了手法治疗，每年的自付费用为39亿美元。 脊柱推拿治疗可以大致分为基于操作或基于活动的技术。 基于操纵的技术（例如，脊柱侧凸（例如脊椎前推）对脊柱施加高速、低振幅的力，并且通常伴随着来自一个或多个关节的可听见的声音。相反，基于移动的技术（例如，肌肉能量）使用通常不产生可听见的关节声音的低速、低力方法。虽然有越来越多的证据表明手法治疗腰痛的临床有效性，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，我们提出了一个治疗盲，假对照研究，以测试的机制和有效性的两个手动治疗技术应用于个人慢性腰痛。具体而言，RELIEF研究（研究腰椎干预措施对增强功能的有效性研究）是一项采用嵌套机制设计的探索性II期随机临床试验（RCT）。 因此，本研究有两个主要目标。 一是确定这两种常用的治疗慢性腰痛的手动治疗干预的生物学机制。 第二项是进行探索性随机对照试验，确定这两种手法治疗在减轻慢性腰痛患者疼痛和残疾方面的有效性，并与其他治疗方法以及假手术对照组进行比较。慢性腰痛受试者将被随机分配至三个治疗组之一：1）脊柱推拿，2）脊柱松动，或3）假超声治疗（n=54/治疗组）。 治疗将每周进行两次，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局组之一，以确定手动治疗对肌肉、脊柱和皮质的影响。治疗干预将每周进行两次，持续3周。将在基线、初始治疗干预后即刻、末次治疗干预后48小时和1个月对受试者进行评估。拟议的实验将提供一个系统的评估肌肉，脊柱和皮质机制的两个最流行的手动治疗LBP的探索性II期随机对照试验设计。