Connective Tissue Motion Measure

描述(申请人提供)：该项目的目标是开发一种生物标记物-结缔组织运动测量(CTMM)-量化肌周结缔组织的功能行为。在由计算机控制的针刺激工具(NST)启动的组织移位(线性振荡)期间，将测量特定结缔组织层之间的差异运动。CTMM适合作为CAM干预机制和临床研究的结果衡量标准。CTMM还将潜在地作为手动治疗师、针灸医生和CAM临床医生对评估患者结缔组织功能状态感兴趣的临床诊断和治疗监测工具。我们的具体目标是：目标1：开发一个综合的、用户友好的和可靠的进行全面核查的系统。1)设计和制造一种能够向目标结缔组织层提供受控位移刺激的自动针刺激工具(NST)。2)将NST与超声换能器集成在临床实用配置中，以允许测量和分析组织位移。3)通过对5名受试者进行1)体外和2)体内测量，初步验证了最优的CTMM程序和数据分析技术。里程碑：这项工作的目标I的成功完成将表明：1.能够实现目标直线针运动要求的可运行的NST装置的完成。2.整个CTMM系统的成功测试表明，在体外和体内都达到了目标针刺精度要求。目的2：对慢性下腰痛(CLBP)患者进行CTMM的初步研究。使用目标1c中确定的最佳程序，我们将测试17名患有慢性下腰痛(CLBP)的受试者和17名没有慢性下腰痛(CLBP)的对照组受试者。里程碑：这项工作的目标一将成功完成，具体情况如下：获得初步数据，以便计算将在第二阶段进行的全面核查研究的样本量。 公共卫生相关性：该项目试图为研究人员和临床医生提供一个生物标记物--结缔组织运动测量--能够记录和监测人类结缔组织的功能状态。其目的是作为一种结果衡量标准，监测可能对结缔组织产生治疗效果的疗法的效果，包括手动疗法、瑜伽和针灸。预计这项技术将确立结缔组织运动测量对包括下腰痛在内的慢性肌肉骨骼疼痛的诊断和临床治疗的有效性。

DESCRIPTION (provided by applicant): The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure (CTMM) - quantifying the functional behavior of perimuscular connective tissues. The differential motion between specific connective tissue strata will be measured during tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus tool (NST). The CTMM will be suitable as an outcome measure for mechanistic and clinical studies of CAM interventions. The CTMM also will potentially serve as a clinical diagnostic and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians interested in assessing the functional status of a patient's connective tissue. Our Specific Aims are: Aim 1: Develop an integrated, user-friendly, and reliable system for conducting the CTMM. 1) Design and fabricate an automated Needle Stimulus Tool (NST) capable of providing a controlled displacement stimulus to the targeted connective tissue strata. 2) Integrating the NST with an ultrasound transducer in a clinically practical configuration allowing for the measurement and analysis of tissue displacement. 3) Preliminary validation of optimal CTMM procedures and data analysis techniques by performing the measure 1) in-vitro and 2) in-vivo in 5 human subjects. Milestones: Successful completion of Aim I of this work will be indicated by the following: 1. Completion of an operational NST device which is capable of achieving the target linear needle motion requirements. 2. Successful testing of the overall CTMM system demonstrating that the target needling accuracy requirements are achieved in-vitro, and in-vivo. Aim 2: Perform a pilot study of CTMM in human subjects with chronic low back pain (cLBP). Using optimal procedures determined in Aim 1c, we will test 17 subjects with chronic low back pain (cLBP) and 17 control subjects without cLBP. Milestone: Successful completion of Aim I of this work will be indicated by the following: Acquisition of preliminary data allowing sample size calculations for full-scale validation studies of the CTMM which will be conducted during Phase 2. PUBLIC HEALTH RELEVANCE: This project attempts to provide researchers and clinicians with a biomarker - the Connective Tissue Motion Measure - capable of documenting and monitoring the functional status of human connective tissues. Its purpose is to function as an outcome measure to monitor the effect of therapies that may have a therapeutic effect on connective tissue including manual therapies and yoga as well as acupuncture. It is anticipated that this technology will establish the usefulness of connective tissue motion measurements for the diagnosis and clinical management of chronic musculoskeletal pain in general, including low back pain.