Electrical Impedance Myography for the Assessment of Neck and Low Back Pain

描述（由申请人提供）：下背部和颈部疼痛是两个最常见的医疗问题。在最近的一项研究中，26.4%的人在过去3个月内有过严重的腰痛，13.8%的人有过严重的颈部疼痛。此外，下背部或颈部疼痛是所有初级保健医生（PCPS）办公室就诊的3%和所有医疗保健就诊的5%的主要投诉。尽管许多患者由于失调而患有肌肉骨骼疾病，但很大一部分患者患有神经根压迫（神经根病），需要不同的治疗模式。仅凭历史和考试来区分这两者是很有挑战性的。这些患者中的许多人接受MRI和专科转诊的脊柱成像，产生额外的费用。因此，PCP的诊断工具可以改善护理并降低成本。一种可以帮助医生正确诊断背部或颈部疼痛原因的技术是电阻抗肌电图（EIM）。与针式肌电图（EMG）一样，EIM可以评估四肢和椎旁肌肉组织的肌肉健康状况。然而，与EMG不同，EIM执行非常快，需要有限的训练，并且是非侵入性的，无痛的， 定量的此外，与EMG不同，它还可以提供有关影响给定肌肉的去调节程度的数据。由于这些原因，以及先前发表的数据，我们假设EIM将帮助医生将下背部或颈部疼痛初步分类为神经根性疼痛或 肌肉骨骼系统我们相信，这将导致降低总体成本和改善结果，因为患者将更快地接受正确的治疗。Convergence Medical Devices，Inc. (CMD)其主要重点是EIM技术的开发。使用第1阶段SBIR和额外的资金，我们已经开发出一种先进的EIM原型，并显示出其区分健康和患病肌肉的能力。在第二阶段的应用中，我们建议改进EIM，用于基于办公室的背部和颈部疼痛评估，目标是改善患者的治疗效果并降低成本。我们将通过以下目标来实现这一目标：（1）我们将收集120名健康受试者多块肌肉的EIM数据（包括50个在资助启动前完成的项目），60个患有专家定义的神经根病，60个患有肌肉骨骼背痛，以开发算法来帮助医生诊断颈部/背痛;（2）我们将改进我们的EIM软件，以方便初级保健医生及其工作人员的解释;和（3）我们将tst易用性，舒适性，并初步评估EIM在临床环境中提高医生诊断背部和颈部疼痛的能力。随着这些目标的完成，CMD将准备好向FDA提交510 k申请，并寻求商业化的第三阶段资金。

DESCRIPTION (provided by applicant): Low back and neck pain are two of the most common medical problems. In a recent study, 26.4% of individuals had an episode of severe low back pain and 13.8% severe neck pain in the preceding 3 months. Moreover, low back or neck pain is the major complaint in 3% of all office visits to primary care physicians (PCPS), and 5% of all healthcare visits overall. Although many patients suffer from musculoskeletal complaints due to deconditioning, a large fraction has nerve root compression (radiculopathy) requiring different treatment paradigms. Discriminating between these two on history and examination alone is challenging. Many of these patients undergo imaging of the spine with MRI and subspecialist referral, incurring additional costs. Thus, a diagnostic tool for PCPs could improve care and reduce costs. One technology that may help physicians correctly diagnose the cause of back or neck pain is electrical impedance myography (EIM). Like needle electromyography (EMG), EIM can give assessment of muscle health in both limbs and paraspinal musculature. Unlike EMG, however, EIM is very fast to perform, requires limited training, and is non-invasive, painless, and quantitative. Moreover, unlike EMG, it can also provide data on the degree of deconditioning affecting a given muscle. For these reasons, and previously published data, we hypothesize that EIM will aid physicians in the initial classification of low back or neck pain as radiculopathic or musculoskeletal in nature. We believe this will result in reduced overall costs and improved outcomes since patients will receive the right therapy sooner. Convergence Medical Devices, Inc. (CMD) has as its primary focus development of EIM technology. Using Phase 1 SBIR and additional funds we have developed an advanced EIM prototype and shown its ability to distinguish between healthy and diseased muscle. In this Phase 2 application, we propose to refine EIM for office-based assessment of back and neck pain, with the goal of improving patient outcomes and reducing costs. We will achieve this through the following aims: (1) We will collect EIM data from multiple muscles on 120 healthy subjects (including 50 completed prior to grant initiation), 60 with expert-defined radiculopathy and 60 with musculoskeletal back pain in order to develop algorithms to aid physicians in diagnosing neck/back pain; (2) We will refine our EIM software to facilitate interpretation by primary care physicians and their staff; and (3) we will tst ease-of-use, comfort, and preliminarily assess EIM's ability to improve a physician's ability to diagnose back and neck pain in a clinical setting. With the completion of these aims, CMD, will be well-poised submit a 510k application to FDA and pursue Phase 3 funding for commercialization.