Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Diagnosis of one of four MP-related categories
研究概览
简要总结
The goal of this observational study is to develop and validate a biomarker for lumbar myofascial pain (MP) based on ultrasound obtained measurements of the lumbar muscles and fascia. The investigators will use advanced machine learning approaches and validation in a randomized controlled trial. The main questions it aims to answer are:
- Will the deep learning-based marker reliably identify subjects from the 4 different groups: healthy, MP without trigger points, MP with latent trigger points, and MP with active trigger points?
- Will the deep learning-based marker accurately classify/predict the severity of MP in subjects with cLBP?
Participants in the healthy group will be asked to do the following tasks:
- Consent/Enrollment
- Measure Height/Weight
- Complete Questionnaires on REDCap
- Participate in Ultrasound Imaging Experiment Sessions
Participants in the chronic low back pain group will be asked to do the following tasks:
- Consent/Enrollment
- Complete Questionnaires on REDCap
- Measure Height/Weight
- Undergo a Standardized Clinical Exam
- Participate in Ultrasound Imaging Experiment Sessions
详细描述
The investigators propose to use multimodal ultrasound imaging to develop and validate a practical and inexpensive biomarker for lumbar myofascial pain, which shows sensitivity to change in relation to treatment. Myofascial pain (MP) is a frequent contributing factor to chronic low back pain (cLBP). It is associated with a range of tissue abnormalities, such as taught muscle bands, trigger points (TPs), and thoracolumbar fascia motion dysfunction, along with poor tissue elasticity. As a result, a composite biomarker for MP related to components of the syndrome is more likely to be plausible biologically, robust, and useful clinically for diagnosis and treatment. The investigators propose to study: 1. The echogenicity of latent and active trigger points, 2. The dynamic spatial-temporal tissue deformation quantified by strain tensors (compression, extension, and shear) in the thoracolumbar fascia and multifidus muscle, 3. The viscoelastic properties of the fascia and muscles measured by ultrasound shear wave elastography. In the R61 Phase (year 1 to 3) the investigators will use deep learning to integrate these measurements into a predictive biomarker and use established validation methods to test its ability to predict MP.
The investigators will determine the sensitivity and specificity of the biomarker to classify the myofascial components of pain, as well as the response to treatment (a diagnostic and predictive marker).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnosis of one of four MP-related categories
时间窗: Study Visit 1 (week 1)
Participants to be diagnosed as normal, MP without TPs, MP with latent TPs, and MP with active TPs as determined by standardized clinical examinations.
次要结局
- Presence of Substantial MP(Study Visit 1 (week 1) - Study Visit 2 (week 2))
研究者
Ajay Wasan, MD, Msc
Professor
University of Pittsburgh
