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下腰痛(LBP)病理生理学中一个潜在的重要因素，但到目前为止大多被忽视。我们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)-量化肌周结缔组织的功能行为。初步数据结果强烈提示慢性LBP患者CTMM降低。在这个项目中，我们计划进一步测试CTMM作为生物标志物在患有和不患有LBP的人类的横断面和纵向研究中的表现。我们还将通过使用价格更低(但性能同样好)的FDA兼容的子组件来升级设备组件，从而提高该项目的商业可行性。目的1：LBP与非LBP患者CTMM(测试)的比较：我们将对144名受试者，72名LBP患者和72名非LBP患者进行CTMM(测试)，对第一阶段的结果进行全面的比较。LBP组和非LBP组在年龄、性别和BMI方面将进行频率匹配。在每个受试者中，将在背部测量一次CTMM。根据我们的初步结果，我们假设LBP组的CTMM将平均减少。目的2：短期重复CTMM的受试者内相关性：我们将评估重复短期测量的CTMM的稳定性。所有在目标1(N=144)中测试的LBP和非LBP受试者将在第一次测试后一小时零一天重新测试。我们假设CTMM在类内相关性(ICC)大于0.8的情况下将是可靠的。目的3：CTMM与临床测量的关系：在目标1(N=72)中测试的所有LBP受试者也将接受LBP症状和损害的既定测量。我们假设CTMM将与数字疼痛指数、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)负相关。所有在目标1(N=72)测试的LBP受试者也将在9个月和15个月后进行重新测试，并反复评估症状和损害(目标n=60；20%自然减少率)。我们假设在预测功能和残疾测试中的时间变化时，CTMM将是一个重要的时变协变量。目标4：升级StromaGlide组件以降低制造成本，并采用符合FDA的设计：我们将用适合商业化的低成本、定制设计的符合FDA的组件取代主要子系统。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。升级后的设备性能将经过验证，以符合现有规格。

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.