权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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/文摘