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Multimodal imaging biomarkers for investigating fascia, muscle and vasculature in myofascial pain.

用于研究肌筋膜疼痛中的筋膜、肌肉和脉管系统的多模态成像生物标志物。

基本信息

批准号：
10569868
负责人：
Siddhartha Sikdar
金额：
$ 148.37万
依托单位：
GEORGE MASON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-21 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10569868
关键词：
Address Anisotropy Biological Markers Biological Process Blood Vessels Blood flow Classification Clinical Clinical Trials Collaborations Communities Complex Connective Tissue Data Data Scientist Development Diagnosis Doppler Ultrasound Double-Blind Method Electromyography Extracellular Fluid Fascia Functional disorder Hyaluronidase Impairment Inflammatory Injections Intercellular Fluid Intervention Lead Liquid substance Longitudinal observational study Lymphatic Measures Methods Modality Monitor Motor Multimodal Imaging Muscle Myofascial Pain Syndromes Needles Nerve Neurogenic Inflammation Observational Study Pain Pain management Pain-Free Pathogenesis Pathologic Processes Pathway interactions Patient Self-Report Patients Perfusion Phase Phenotype Physical Examination Physicians&apos Offices Physiological Physiological Processes Placebo Control Play Prediction of Response to Therapy Radiology Specialty Randomized Randomized Clinical Trials Recording of previous events Reproducibility Role Scanning Sensitivity and Specificity Spectrum Analysis Surface Time Tissues Ultrasonography Vascular remodeling base clinical heterogeneity clinical imaging clinical phenotype clinical practice clinical predictors data acquisition density design diagnostic tool elastography evidence base fluid flow imaging biomarker imaging scientist improved innovation insight interstitial lymphatic drainage multimodality neurobiological mechanism novel response soft tissue success ultrasound

项目摘要

Summary/Abstract Myofascial pain syndrome (MPS) is highly prevalent in the community. It is primarily diagnosed using patient self reports and physical examination, which lack reliability, sensitivity and specificity and does not provide insights into the abnormal biological and physiological processes in soft tissues. While a number of treatment methods are available to patients, there are currently no criteria to determine which treatments might be best for each patient’s unique myofascial pain phenotype. To improve evidence-based management of myofascial pain, there is a critical need to develop quantitative measures that advance our understanding of the physiological processes in the underlying the soft tissues across the clinical continuum of MPS. The objective of this project is to develop a quantitative biomarker informed by the current understanding of underlying tissue-level mechanisms at the level of the “myofascial unit” (muscle, nerve, fascia, vasculature, lymphatics) that are likely to be involved in MPS. This project has two phases: a R61 phase for developing and validating the biomarker and an R33 phase for utilizing the biomarker for treatment monitoring in a randomized clinical trial of two different mechanism-based interventions. The R61 phase has two specific aims: Specific Aim 1: Develop and refine quantitative measures of muscle, fascia, interstitium and blood flow and determine reproducibility. The measures will be based on quantifying three physiological mechanisms: (1) Aim 1a: impaired myofascial gliding quantified through measures of shear anisotropy using ultrasound shear wave elastography; (2) Aim 1b: abnormal accumulation of interstitial fluid and impaired perfusion quantified through ultrasound elastography, Doppler ultrasound and bioimpedance spectroscopy; (3) Aim 1c: increased motor unit excitability associated with segmental sensitization quantified through high-density surface electromyography. Specific Aim 2: Develop and clinically validate a composite classifier of myofascial state. We will measure the tissue-level biomarkers in a longitudinal observational study of patients with myofascial pain and pain-free controls. The classifier will be designed to predict clinical phenotypes that include within subject variability over time, as well as variability between subjects with myofascial pain and controls. The transition criteria from the R61 to R33 phase will be achieving >90% classification accuracy using a classifier based on tissue-level biomarkers to differentiate between normal, latent, and active phases. Our objective in the R33 phase is to determine the sensitivity and specificity of the composite classifier to predict treatment response. To evaluate whether the composite measure is sensitive to mechanism-based changes, we will evaluate two interventions that target two different mechanistic pathways: dry needling targeting segmental sensitization, and hyaluronidase injections targeting impaired fascial gliding. We will conduct a randomized, placebo-controlled double-blind clinical trial of the two interventions using a factorial design.

摘要/摘要肌筋膜疼痛综合征(MPS)在社区中非常普遍。它主要是通过患者自己的诊断。报告和体检，缺乏可靠性、敏感性和特异性，不能提供洞察力软组织中的异常生物和生理过程。虽然有一些治疗方法可供患者使用，但目前还没有标准来确定哪种疗法对每种疗法可能是最好的患者独特的肌筋膜疼痛表型。为了改善对肌筋膜痛的循证管理，有是一个迫切需要发展的量化措施，以提高我们对生理过程的理解在MPS临床连续体的底层软组织中。这个项目的目标是开发一个定量的生物标记物，由目前对潜在的组织水平机制的理解提供信息可能参与的“肌筋膜单位”(肌肉、神经、筋膜、血管、淋巴管)的水平国会议员。该项目分为两个阶段：用于开发和验证生物标志物的R61阶段和R33阶段在两个不同机制的随机临床试验中利用生物标记物进行治疗监测干预措施。 R61阶段有两个具体目标：具体目标1：制定和完善肌肉、筋膜、间质和血流的定量测量方法确定重复性。这些措施将基于量化三种生理机制：(1)目的 1A：通过超声剪切波测量剪切各向异性来量化受损的肌筋膜滑动弹性成像；(2)目标1b：间质液体异常堆积和灌注受损通过超声弹性成像、多普勒超声和生物阻抗谱；(3)目标1c：增加运动单位与节段性敏感化相关的兴奋性通过高密度表面肌电图定量。具体目标2：研制肌筋膜状态复合分类器并进行临床验证。我们将测量肌筋膜痛和无痛患者的组织水平生物标志物的纵向观察研究控制。该分类器将被设计用来预测临床表型，包括在受试者的变异范围内时间，以及肌筋膜痛受试者和对照组之间的变异性。从R61到R33阶段的过渡标准将使用分类器达到90%的分类精度基于组织水平的生物标记物来区分正常、潜伏期和活动期。我们在R33阶段的目标是确定要预测的复合分类器的敏感性和特异性治疗反应。为了评估综合指标是否对基于机制的变化敏感，我们我将评估两种针对两种不同机制路径的干预措施：干针针对节段性敏化和透明质酸酶注射针对筋膜滑动受损。我们将进行一个随机的，采用析因设计进行两种干预措施的安慰剂对照双盲临床试验。