Automated Connective Tissue Torque Sensor

自动结缔组织扭矩传感器

• 批准号: 7856941
• 负责人: Robert T Davis
• 金额: $ 37.5万
• 依托单位: STROMATEC, INC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7856941
• 关键词: Absenteeism; Achievement; Acupuncture procedure; Address; Age; Biological Markers; Biomechanics; Chronic; Chronic low back pain; Clinical; Clinical Research; Collection; Connective Tissue; Connective Tissue Diseases; Data; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Documentation; Drops; Ensure; Fibromyalgia; Frequencies; Functional disorder; Funding; Glean; Goals; Health; Health Care Costs; Healthcare Systems; Human; In Vitro; Inherited; Insurance; Link; Longevity; Longitudinal Studies; Manuals; Massage; Measurement; Measures; Methods; Modification; Monitor; Musculoskeletal; Musculoskeletal Diseases; Musculoskeletal Pain; Myofascial Pain Syndromes; Nature; Needles; Outcome Measure; Pain; Pathology; Patient Monitoring; Patients; Performance; Phase; Population; Positioning Attribute; Problem Solving; Procedures; Protocols documentation; Research; Rotation; Scleroderma; Simulate; Site; Source; Spinal Manipulation; Stimulus; Technology; Testing; Therapeutic; Time; Tissues; Torque; Variant; Work; Writing; Yoga; biceps brachii muscle; clinical practice; commercialization; commercially viable technology; design; disability; flexibility; hamstring; human subject; improved; in vivo; prototype; public health relevance; rectus femoris; response; sensor; sex; stressor; treatment effect

DESCRIPTION (provided by applicant): The long term goal of this project is to develop a biomarker - the Needle Torque Test (NTT) - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders. The NTT is administered by inserting an acupuncture needle into connective tissue and using the Automated Needle Torque Sensor to deliver a precise biomechanical stimulus to the needle probe via rotation. The tissue response to this stimulus is quantified as torque. Our Specific Aims are: 1) Document Automated Needle Torque Sensor device and Needle Torque Test procedural reliability in vitro. This will be achieved by making structural and methodological refinements designed to insure measurement consistency, and documenting device performance under simulated clinical conditions against known torques. 2) Document the Needle Torque test/retest reliability in vivo. To fulfill this aim, we will perform a longitudinal study in 100 healthy human subjects without musculoskeletal pain or pathology, repeating testing of 6 points on the biceps femoris, rectus femoris, and biceps brachii at three time points (time 0, 30 minutes and 1 week). 3) Validate the NTT as a biomarker capable of identifying connective tissue abnormalities by: a) establishing an NTT/connective tissue disorder link. We will collect and compare NTT scores in 15 subjects with scleroderma, and 15 subjects with inherited connective tissue disorders manifesting as connective tissue hyperlaxity, compared with 30 control subjects from Aim 2 that are frequency-matched for age and sex and b) establishing an NTT/musculoskeletal disorder link. We will collect and compare NTT scores in 15 subjects with restricted hamstring flexibility, compared with 15 control subjects from Aim 2 with normal hamstring flexibility who have been frequency-matched for age and sex. PUBLIC HEALTH RELEVANCE: Chronic musculoskeletal pain is the source of considerable disability, work absenteeism and health care costs. A major obstacle to the incorporation of manual therapies such as massage and spinal manipulation into our health care system is the lack of methods to objectively measure the effect of treatments. Automated Needle Torque Sensor technology under development in this project will potentially enable objective measurement of connective tissue abnormalities associated with musculoskeletal pain. This will 1) help establish the efficacy of manual treatments through improved research, 2) enhance the objective monitoring of patient progress in clinical practice and 3) bolster the evidence needed to justify insurance reimbursement.

描述（由申请方提供）：本项目的长期目标是开发一种生物标志物----缝针扭矩试验（NTT）----能够检测与肌肉骨骼疾病相关的结缔组织异常。通过将针灸针插入结缔组织并使用自动针扭矩传感器通过旋转向针探头提供精确的生物力学刺激来进行NTT。组织对这种刺激的反应被量化为扭矩。我们的具体目标是：1）记录自动针头扭矩传感器器械和针头扭矩测试程序的体外可靠性。这将通过对结构和方法进行改进来实现，以确保测量的一致性，并记录在模拟临床条件下针对已知扭矩的器械性能。2)记录体内缝针扭矩试验/复检可靠性。为了实现这一目标，我们将在100名没有肌肉骨骼疼痛或病理的健康人类受试者中进行纵向研究，在三个时间点（时间0、30分钟和1周）重复测试股二头肌、股直肌和肱二头肌上的6个点。3)将NTT作为能够通过以下方式鉴定结缔组织异常的生物标志物：a）建立NTT/结缔组织疾病联系。我们将收集并比较15名硬皮病受试者和15名表现为结缔组织过度松弛的遗传性结缔组织疾病受试者的NTT评分，并与目标2中年龄和性别频率匹配的30名对照受试者进行比较，B）建立NTT/肌肉骨骼疾病联系。我们将收集并比较15名腘绳肌柔韧性受限受试者的NTT评分，并与15名年龄和性别频率匹配的来自Aim 2的正常腘绳肌柔韧性对照受试者进行比较。 公共卫生相关性：慢性肌肉骨骼疼痛是造成严重残疾、缺勤和医疗保健费用的原因。将按摩和脊柱推拿等手工疗法纳入我们的医疗保健系统的一个主要障碍是缺乏客观衡量治疗效果的方法。本项目中正在开发的自动针扭矩传感器技术将有可能实现与肌肉骨骼疼痛相关的结缔组织异常的客观测量。这将有助于1）通过改进研究确定手动治疗的有效性，2）加强对临床实践中患者进展的客观监测，3）支持证明保险报销合理性所需的证据。