Washington University
St Louis, Missouri, 63110, United States
NCT Number: NCT06036524
The goal of this study is to develop new imaging biomarkers for quantitative assessments of myofascial pain.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Healthy Volunteer Inclusion Criteria:
Healthy Volunteer Exclusion Criteria:
Myofascial Pain Patient Inclusion Criteria:
Myofascial Pain Patient Exclusion Criteria:
Study Participants will undergo four study procedures at one visit, including magnetic resonance imaging (MRI), surface electromyography (sEMG), fiber-optic imaging and sensing, and questionnaires.
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.
Washington University School of Medicine
Other
Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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