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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：
8681365
负责人：
Jose Luis Bohorquez
金额：
$ 53.33万
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 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8681365
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）：下背部和颈部疼痛是两种最常见的医学问题。在最近的一项研究中，26.4%的人在前3个月有过严重的腰痛，13.8%的人有过严重的颈部疼痛。此外，在初级保健医生（pps）的所有办公室就诊中，腰痛或颈部疼痛是3%的主要主诉，在所有医疗保健就诊中占5%。尽管许多患者由于身体状况的改善而患有肌肉骨骼疾病，但很大一部分患者有神经根受压（神经根病），需要不同的治疗方法。仅凭历史和考试来区分这两者是具有挑战性的。这些患者中的许多人接受MRI脊柱成像和专科转诊，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。一项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图（EIM）。像针肌电图（EMG）一样，EIM可以评估四肢和脊柱旁肌肉组织的肌肉健康状况。然而，与肌电图不同的是，EIM的执行速度非常快，只需要很少的训练，而且是非侵入性的，无痛的，并且可以快速进行