Total-body PET for assessing myofascial pain

项目摘要 肌筋膜疼痛综合征（MPS）是一种普遍存在的衰弱性疾病，对社会造成了重大负担。这种综合征可能作为一种孤立的疾病发生，通常局限于下背部区域，或者是影响肌筋膜单位的更复杂的临床情况的一部分，如血红蛋白病，炎症，癌症和创伤。用于MPS定性或定量评估的经验证的生物标志物缺乏。该提案的目的是建立源自全身正电子发射断层扫描/计算机断层扫描（TB-PET/CT）的新措施，作为定量生物标志物，以监测有可能缓解肌筋膜疼痛的干预措施的反应和预测结果。我们将评估的TB-PET/CT指标包括反映肌筋膜组织代谢、灌注和脂肪浸润的指标。这些过程与肌筋膜组织功能障碍密切相关，监测它们可提供评估疼痛来源的方法。因此，本提案响应了RFA-AT-22-003，并解决了关注领域：“组织代谢、灌注、氧合和脂肪浸润的定量评价”。本提案中评估的情况是慢性腰痛。我们假设TB-PET/CT测量将（1）提供对这种情况下肌筋膜组织病理学的独特见解;（2）提供与肌筋膜组织功能障碍和干预反应相关的生物标志物。 拟议项目将分两个阶段进行。第一个是R61阶段，我们将进行观察性、横断面研究。在此阶段，我们将建立定量TB-PET/CT测量与HEAL结局测量的关联，并将确定区分患病与健康肌筋膜组织的TB-PET/CT测量。第二阶段将是R33阶段，我们将进行一项随机、对照的纵向干预性研究。受试者将被随机分配到干预组或对照组。在此阶段，我们将确定TB-PET/CT措施跟踪HEAL结局指标变化的能力。我们已经定义了定量转换标准，将应用于R61阶段的成像措施，然后将其引入R33阶段。因此，通过这项工作，我们希望建立TB-PET/CT测量作为潜在的生物标志物，为表征肌筋膜组织提供急需的客观性，灵敏度和精确度，并作为功能障碍，疼痛和预测和监测干预反应的替代措施。

Project Summary Myofascial pain syndrome (MPS) is a prevalent and debilitating condition representing a significant burden to society. This syndrome may occur as an isolated condition, often localized in the lower back area, or be part of more complex clinical scenarios, such as hemoglobinopathy, inflammation, cancer and trauma, that affect the myofascial unit. There is a paucity of validated biomarkers for qualitative or quantitative assessment of MPS. The objective of this proposal is to establish novel measures derived from Total-body-Positron Emission Tomography/Computed Tomography (TB-PET/CT) as quantitative biomarkers to monitor response and predict outcomes for interventions that have potential to relieve myofascial pain. The TB-PET/CT measures we will assess include those reflective of myofascial tissue metabolism, perfusion, and fatty infiltration. These processes are intimately associated with myofascial tissue dysfunction and monitoring them may provide means to assess sources of pain. Therefore, this proposal is responsive to the RFA-AT-22-003 and addresses the interest area: “Quantitative evaluation of tissue metabolism, perfusion, oxygenation, and fatty infiltration”. The condition assessed in this proposal is chronic low back pain. We hypothesize that TB-PET/CT measures will (1) offer a unique insight into myofascial tissue pathology in this condition; and (2) provide biomarkers that will associate with myofascial tissue dysfunction and response to interventions. The proposed project will have two phases. The first is the R61 phase where we will conduct an observational, cross-sectional study. In this phase we will establish the association of quantitative TB-PET/CT measures with HEAL outcome measures and will determine TB-PET/CT measures that differentiate diseased versus healthy myofascial tissue. The second phase will be the R33 phase where we will carry out a randomized, controlled longitudinal interventional study. Participants will be randomly assigned to the intervention arm or the control arm. In this phase we will determine the capability of TB-PET/CT measures to track with changes in HEAL outcome measures in response to the intervention. We have defined quantitative transition criteria that will be applied to the imaging measures in the R61 phase before introducing them into the R33 phase. Therefore, through this work we hope to establish TB-PET/CT measures as potential biomarkers for providing the much-needed objectivity, sensitivity, and precision for characterizing myofascial tissue, and as surrogate measures for dysfunction, pain and for predicting and monitoring response to interventions.