Multi-modal Imaging of Myofascial Pain

August 31, 2026 updated by: Washington University School of Medicine

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Healthy Volunteer Inclusion Criteria:

  1. 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
  2. A numerical current pain index of lower than 0.5 according to initial assessment with visual analog scale
  3. Able to understand the goal of the project and give informed consent.

Healthy Volunteer Exclusion Criteria:

  1. Pregnancy or breastfeeding
  2. Contraindication to MRI
  3. Previous severe/acute neck or shoulder injury
  4. Previous neck or shoulder surgery
  5. Neck or shoulder deformities
  6. Inability to provide consent.

Myofascial Pain Patient Inclusion Criteria:

  1. Between the ages of 18 and 80 years old
  2. Neck and/or shoulder pain, unilateral or bilateral
  3. Duration of symptoms for longer than 4 weeks
  4. Pain scale at the active state higher than 4 according to initial assessment with visual analog scale
  5. Presence of active trigger point(s) according to palpation and/or presence of taut band

Myofascial Pain Patient Exclusion Criteria:

  1. Recent history of trauma to the neck (e.g., whiplash)
  2. Acute cervical radiculopathy
  3. Acute cervical spine pain component or acute cervical spinal pathology Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g., dermatomyositis)
  4. Systemic disease with diffuse body pain (e.g., system lupus erythematosus and and thyroid disease)
  5. Peripheral neuropathy
  6. Cancer-related pain
  7. 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
  8. Contraindication to MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-modal imaging of myofascial pain
Participants with and without myofascial-related pain disease will receive multi-modal, multi-parametric, multi-scale imaging, including magnetic resonance imaging, surface electromyography, and fiber-optic imaging and sensing.
Diagnostic test: Multi-modal, multi-parametric, multiscale imaging of the myofascial unit
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201039
  • R61AT012283 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe