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Active, Not Recruiting

NCT Number: NCT06036524

Multi-modal Imaging of Myofascial Pain

The goal of this study is to develop new imaging biomarkers for quantitative assessments of myofascial pain.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy Volunteer 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
  • Pain scale at the active state higher than 4 according to initial assessment with visual analog scale
  • Presence of active trigger point(s) according to palpation and/or presence of taut band

Myofascial Pain Patient Exclusion Criteria:

  • Recent history of trauma to the neck (e.g., whiplash)
  • Acute cervical radiculopathy
  • Acute cervical spine pain component or acute cervical spinal pathology Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g., dermatomyositis)
  • Systemic disease with diffuse body pain (e.g., system lupus erythematosus and and thyroid disease)
  • Peripheral neuropathy
  • Cancer-related pain
  • Pregnancy, coagulopathy, fever, general/local infection at the pain site, substance abuse, peripheral neuropathy, or any other diseases that may account for signs and symptoms mimicking myofascial pain
  • Contraindication to MRI.

Treatment and study plan

Multi-modal, multi-parametric, multiscale imaging of the myofascial unit

Diagnostic Test

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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