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

描述(申请人提供)：腰背和颈部疼痛是两个最常见的医学问题。在最近的一项研究中，26.4%的人在之前的3个月内有过严重的下腰痛和13.8%的严重颈部疼痛。此外，在所有初级保健医生(PCP)的办公室就诊中，腰痛或颈部疼痛是主要主诉，在所有医疗就诊中，分别占3%和5%。虽然许多患者因去条件化而遭受肌肉骨骼疾病的困扰，但很大一部分患者有神经根受压(神经根病)，需要不同的治疗方案。仅在历史和考试上区分这两种人就很有挑战性。这些患者中的许多人接受了MRI和专科医生的脊柱成像，从而产生了额外的费用。因此，针对初级保健医生的诊断工具可以改善护理并降低成本。有一种技术可以帮助医生正确诊断背部或颈部疼痛的原因，那就是阻抗肌电成像(EIM)。与针状肌电图(EMG)一样，EIM可以评估四肢和椎旁肌肉的健康状况。然而，与肌电不同的是，EIM执行起来非常快，只需要有限的培训，而且是非侵入性的、无痛的 量化的。此外，与肌电不同的是，它还可以提供影响特定肌肉的去条件化程度的数据。由于这些原因，以及之前发表的数据，我们假设EIM将帮助医生将下腰或颈部疼痛初步归类为神经根性或神经根性疼痛。 自然界中的肌肉骨骼。我们相信这将导致总体成本的降低和结果的改善，因为患者将更快地接受正确的治疗。融合医疗设备公司(CMD)将EIM技术的开发作为其主要重点。利用第一阶段的SBIR和额外的资金，我们已经开发了一个先进的EIM原型，并展示了它区分健康和患病肌肉的能力。在这个第二阶段的应用中，我们建议改进EIM，用于基于办公室的背部和颈部疼痛评估，目标是改善患者结果并降低成本。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(包括50名在获得许可之前完成)、60名专家定义的神经根病患者和60名肌肉骨骼背痛患者的EIM数据，以开发算法来帮助医生诊断颈/背痛；(2)我们将完善我们的EIM软件，以便于初级保健医生及其工作人员进行解释；以及(3)我们将测试EIM的易用性、舒适性，并初步评估EIM在临床环境下提高医生诊断背痛和颈部疼痛的能力。随着这些目标的实现，CMD将做好准备，向FDA提交510K申请，并寻求第三阶段的资金用于商业化。

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.