Connective Tissue Motion Measure 2

描述（由申请人提供）：结缔组织功能障碍正在成为慢性腰痛（LBP）病理生理学中一个潜在的重要因素，但迄今为止大多被忽视。我们已经开发并测试了一种新的仪器（StromaGlide）和测试（结缔组织运动测量- CTMM） -量化肌肉周围结缔组织的功能行为。初步数据的结果强烈提示慢性腰痛患者CTMM减少。在这个项目中，我们计划进一步测试CTMM作为生物标志物在有和没有腰痛的人的横断面和纵向研究中的性能。我们还将通过使用更便宜（但同样性能良好）的FDA合规子组件升级设备组件来提高项目的商业可行性。目标1:CTMM（测试）在腰痛与无腰痛患者中的比较：我们将跟进第一阶段的结果，对144名受试者进行CTMM的全功率比较，其中72名患有腰痛，72名没有腰痛。腰痛组和无腰痛组将根据年龄、性别和体重指数进行频率匹配。每个受试者在背部双侧测量CTMM一次。根据我们的初步结果，我们假设LBP组的CTMM平均会减少。目的2：短期重复CTMM的受试者内相关性：我们将评估CTMM在重复短期测量中的稳定性。所有在Aim 1中测试的LBP和无LBP受试者（N=144）将在首次测试后1小时和1天重新测试。我们假设CTMM在类内相关系数（ICC）大于0.8时是可靠的。目的3:CTMM与临床测量的关系：在目的1中测试的所有LBP受试者（N=72）也将用既定的LBP症状和损害测量方法进行评估。我们假设CTMM与数值疼痛指数、McGill疼痛评分、Oswestry残疾指数和功能测量评分（50英尺步行、重复坐立和重复前屈）呈负相关。所有在Aim 1中测试的LBP受试者（N=72）也将在9个月和15个月后重新测试，并重复评估症状和损害（目标N= 60； 20%损耗容许）。我们假设CTMM将是预测功能和残疾测试中时间变化的重要时变协变量。目标4：升级StromaGlide组件以降低制造成本并采用符合FDA标准的设计：我们将用适合商业化的低成本、定制设计的符合FDA标准的组件替代主要子系统。这不会改变设备性能，相反，它将显著降低这些子系统的估计制造成本。将验证升级后的设备性能是否符合现有规格。

DESCRIPTION (provided by applicant): Connective tissue dysfunction is emerging as a potentially important, and so far mostly overlooked, factor in the pathophysiology of chronic low back pain (LBP). We have developed and tested a novel instrument (StromaGlide) and test (Connective Tissue Motion Measure - CTMM) -quantifying the functional behavior of perimuscular connective tissues. The results of preliminary data strongly suggest that CTMM is reduced in chronic LBP. In this project, we plan to further test the performance of the CTMM as a biomarker in cross sectional and longitudinal studies of humans with and without LBP. We will also improve the commercial viability of the project by upgrading device components with less expensive (but equally well performing) FDA compliant subcomponents. Aim 1: Comparison of CTMM (test) in LBP vs No-LBP: We will follow up on the results of Phase 1 with a fully powered comparison of CTMM across 144 subjects, 72 with LBP and 72 with No-LBP. LBP and No-LBP groups will be frequency-matched for age, sex and BMI. In each subject, CTMM will be measured once bilaterally in the back. Based on our preliminary results, we hypothesize that CTMM will be reduced on average in the LBP group. Aim 2: Within-subject correlation of short term repeated CTMM: We will assess the stability of CTMM over repeated short term measurements. All LBP and No-LBP subjects tested in Aim 1 (N=144) will be re-tested one hour and one day following the initial test. We hypothesize that the CTMM will be reliable with an intra class correlation (ICC) greater than 0.8. Aim 3: Relationship of CTMM to clinical measures: All LBP subjects tested in Aim 1 (N=72) will also be evaluated with established measures of LBP symptoms and impairment. We hypothesize that CTMM will negatively correlate with the numeric pain index, McGill pain score, Oswestry disability index and functional measure score (50 foot walk, repeated sit-to-stand and repeated forward bend). All LBP subjects tested in Aim 1 (N=72) will also be retested 9 months and 15 months later along with repeated assessment of symptoms and impairment (target n=60; 20% attrition allowance). We hypothesize that CTMM will be a significant time-varying covariate in predicting temporal changes in the functional and disability tests. Aim 4: Upgrade StromaGlide components to decrease manufacturing costs and adopt an FDA compliant design: We will substitute principal subsystems with low-cost, custom designed FDA compliant components suitable for commercialization. This will not alter device performance, rather it will reduce estimated manufacturing costs of these subsystems significantly. Upgraded device performance will be verified to match existing specifications.