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）病理生理学中的一个潜在重要因素，但迄今为止大多被忽视。我们开发并测试了一种新型仪器（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。初步数据的结果强烈表明，CTMM是减少慢性LBP。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LBP的人类的横截面和纵向研究中的性能。我们还将通过使用更便宜（但性能同样良好）的FDA合规子组件升级器械组件来提高项目的商业可行性。目标1：LBP与无LBP患者的CTMM（试验）比较：我们将对第1阶段的结果进行随访，对144例受试者（72例LBP受试者和72例无LBP受试者）的CTMM进行完全把握度比较。LBP组和无LBP组将在年龄、性别和BMI方面进行频率匹配。在每例受试者中，将在背部双侧测量一次CTMM。根据我们的初步结果，我们假设，CTMM将减少平均在LBP组。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。在目标1中测试的所有LBP和无LBP受试者（N=144）将在初始测试后1小时和1天重新测试。我们假设CTMM是可靠的，类内相关性（ICC）大于0.8。目标3：CTMM与临床指标的关系：还将采用LBP症状和损伤的既定指标评价目标1中测试的所有LBP受试者（N=72）。我们假设CTMM将与数字疼痛指数、麦吉尔疼痛评分、奥斯韦斯特里残疾指数和功能测量评分（50英尺步行、重复坐立和重复前向弯曲）呈负相关。在目标1中测试的所有LBP受试者（N=72）也将在沿着9个月和15个月后重新测试，并重复评估症状和损伤（目标n=60; 20%损耗津贴）。我们假设，CTMM将是一个重要的随时间变化的协变量，在预测功能和残疾测试的时间变化。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，而是会显著降低这些子系统的估计制造成本。将验证升级后的器械性能是否符合现有规范。 公共卫生相关性：该项目的成功有望通过提供识别结缔组织病理学的客观手段来改善肌肉骨骼疾病（如慢性特发性腰痛）的治疗。这将通过为医生、付款人和患者提供急需的信息来改善对大量患有昂贵的慢性特发性肌肉骨骼疼痛和功能障碍的患者的治疗，从而产生重大的临床影响。

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. PUBLIC HEALTH RELEVANCE: The success of this project promises to improve the treatment of musculoskeletal disorders such as chronic idiopathic low back pain by providing an objective means for identifying connective tissue pathology. This would make a significant clinical impact by providing physicians, payers, and patients with much-needed information to improve the treatment of the large group of patients who suffer from costly chronic idiopathic musculoskeletal pain and dysfunction.