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

用于评估颈部和腰痛的电阻抗肌电图

基本信息

批准号：
8454692
负责人：
Jose Luis Bohorquez
金额：
$ 56.84万
依托单位：
MYOLEX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-07-01 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8454692
关键词：
Adopted Affect Algorithms Back Back Pain Body Regions Boston Businesses Caring Classification Clinical Code Color Computer software Data Data Collection Development Diagnosis Diagnostic Discrimination Electromyography Evaluation Feedback Focus Groups Funding Goals Grant Health Health Care Visit High Prevalence Image Individual Israel Limb structure Low Back Pain Magnetic Resonance Imaging Medical Medical Device Medical center Muscle Musculoskeletal Musculoskeletal Pain Myography Nature Neck Neck Pain Needles Nerve Root Compressions Office Visits Outcome Painless Patients Pattern Phase Physicians Primary Care Physician Primary Health Care Procedures Process Publishing Radiculopathy Recording of previous events Running Small Business Innovation Research Grant Specialist System Techniques Technology Testing Training Vertebral column Work base commercialization cost design electric impedance improved input device phase 2 study prototype public health relevance tool

项目摘要

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.

描述（由申请人提供）：腰痛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 个月内曾出现过严重腰痛，13.8% 的人曾出现过严重颈部疼痛。此外，腰痛或颈部疼痛是初级保健医生 (PCPS) 就诊中 3% 以及所有医疗保健就诊中 5% 的主要主诉。尽管许多患者因去适应而遭受肌肉骨骼疾病的困扰，但很大一部分患者患有神经根受压（神经根病），需要不同的治疗模式。仅凭历史和检查来区分这两者是具有挑战性的。其中许多患者接受 MRI 脊柱成像和亚专科转诊，从而产生额外费用。因此，针对 PCP 的诊断工具可以改善护理并降低成本。电阻抗肌电图 (EIM) 是一项可以帮助医生正确诊断背部或颈部疼痛原因的技术。与针肌电图 (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 不同的是，EIM 执行速度非常快，需要有限的培训，并且是非侵入性、无痛的，并且定量的。此外，与肌电图不同的是，它还可以提供影响特定肌肉的失调程度的数据。由于这些原因以及之前发表的数据，我们假设 EIM 将帮助医生将腰痛或颈部疼痛初步分类为神经根性疼痛或本质上是肌肉骨骼。我们相信，这将降低总体成本并改善结果，因为患者将更快地接受正确的治疗。 Convergence Medical Devices, Inc. (CMD) 将 EIM 技术的开发作为其主要重点。利用第一阶段 SBIR 和额外资金，我们开发了先进的 EIM 原型，并展示了其区分健康和患病肌肉的能力。在此第 2 阶段应用中，我们建议改进 EIM，用于基于办公室的背部和颈部疼痛评估，目的是改善患者的治疗效果并降低成本。我们将通过以下目标实现这一目标：(1) 我们将从 120 名健康受试者（包括 50 名在资助开始前完成的受试者）、60 名患有专家定义的神经根病的受试者和 60 名患有肌肉骨骼背痛的受试者的多个肌肉中收集 EIM 数据，以便开发帮助医生诊断颈部/背部疼痛的算法； (2) 我们将完善我们的 EIM 软件，以方便初级保健医生及其工作人员的解释； (3) 我们将测试易用性、舒适度，并初步评估 EIM 提高医生在临床环境中诊断背部和颈部疼痛的能力的能力。随着这些目标的完成，CMD 将做好向 FDA 提交 510k 申请并寻求商业化第 3 阶段资金的准备。