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： 该应用是对计划公告PA-10-209的响应，手动疗法的生物学。NIH认识到下背痛（LBP）是一个重大的健康问题，并且对于该疾病最受欢迎的治疗方法之一（即操纵治疗）缺乏机械性研究。在医疗费用，残疾和个人痛苦方面，背痛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，18000岁以上的1800万美国人在2007年接受了操纵疗法，每年的零售价为39亿美元。基于脊柱操纵的治疗可以广泛地归类为基于操作或基于动员的技术。基于操作的技术（例如，翻译推力）在脊柱上施加高速，低振幅力，并且通常伴随着一个或多个关节的可听见声音。相反，基于动员的技术（例如，肌肉能量）使用低速，低强度方法，通常不会产生可审核的关节声音。尽管有越来越多的证据表明操纵疗法治疗腰痛的临床有效性，但几乎没有关于基于操纵或基于动员的治疗的生理后果和影响的知识。此外，还需要增加数据来了解这些不同的手动治疗技术如何有效疼痛和残疾的临床变化。根据，我们提出了一项研究人员，假对照的研究，以测试应用于慢性腰痛患者的两种手动治疗技术的机制和有效性。具体而言，救济研究（研究腰部干预措施增强功能研究的有效性）是一项具有嵌套机械设计的II期随机临床试验（RCT）。因此，这项研究有两个主要目标。一种是确定这两种手动治疗干预措施的生物学机制，通常用于治疗慢性下背部疼痛。第二个是进行探索性RCT确定这两种手动疗法在减轻慢性下背部疼痛患者的疼痛和残疾方面的有效性相比，以及假对照组。患有慢性腰痛的参与者将随机分配给三个治疗组之一：1）脊柱操纵，2）脊柱动员，或3）假手术超声治疗（n = 54/治疗组）。 3周的治疗将每周两次进行。在每个治疗组中，研究参与者将被随机分配给三个身体结局组之一，以确定手动疗法的肌肉，脊柱和皮质效应。 3周的治疗干预措施每周将两次提供两次。参与者将在最初的治疗干预措施，48小时和最后一次治疗干预后的1个月后立即评估参与者。提出的实验将对在探索性II阶段II RCT设计中治疗LBP的两种最受欢迎​​的手动疗法的肌肉，脊柱和皮质机制进行系统评估。