Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myofascial Pain
- Sponsor
- Washington University School of Medicine
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Statistical Plan
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The goal of this study is to develop new imaging biomarkers for quantitative assessments of myofascial pain.
Detailed Description
This study aims to develop a multi-modal, multi-parametric, multi-scale imaging of the human myofascial unit by combining magnetic resonance imaging (MRI), surface electromyography (sEMG), and fiber-optic imaging and sensing. Participants (half with active neck/shoulder/back pain, and half healthy controls) will be recruited from pain management clinics and Volunteer for Health, or will be referred by Dr. Xioabin Yi. They will undergo all three imaging techniques and complete a number of patient questionnaires over the course of a single study visit. The study team will then identify candidate biomarkers capable of differentiating between healthy (no myofascial pain) and those with active pain to target in a future clinical trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Absence of a history of chronic pain in the targeted anatomical location (i.e., neck and shoulder) that had limited activities of daily living or work
- •A numerical current pain index of lower than 0.5 according to initial assessment with visual analog scale
- •Able to understand the goal of the project and give informed consent.
- •Healthy Volunteer
Exclusion Criteria
- •Pregnancy or breastfeeding
- •Contraindication to MRI
- •Previous severe/acute neck or shoulder injury
- •Previous neck or shoulder surgery
- •Neck or shoulder deformities
- •Inability to provide consent.
- •Myofascial Pain Patient Inclusion Criteria:
- •Between the ages of 18 and 80 years old
- •Neck and/or shoulder pain, unilateral or bilateral
- •Duration of symptoms for longer than 4 weeks
Outcomes
Primary Outcomes
Statistical Plan
Time Frame: For each individual, multi-modal imaging will be performed on the same day. Magnetic Resonance Imaging (MRI) will take about 1 hour. Fiber-optic measurements will take a few minutes. Surface electromyography (sEMG) recording will take <20 minutes.
The statistical analysis will assess the capability of imaging-based quantitative biomarkers to distinguish the pathological and physiological differences between participant groups (i.e., myofascial pain patients vs. healthy volunteers). The imaging biomarkers will be measured for each participant, including tissue stiffness, hydration, inflammation, blood oxygenation and flow, electrical activity, etc. The biomarkers will be measured and compared in the univariate fashion, which means we assess the differentiation performance for each biomarker independently. For each biomarker, we will compare the difference between the participant groups, using the Student's t-test or Wilcoxon rank-sum test. The statistical power will be estimated based on the effect size (Cohen's d) of difference between the participant groups. With an expected effect size of \>0.9, the proposed sample size can achieve a statistical power greater than 0.8.