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Multi-modal Imaging of Myofascial Pain

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ClinicalTrials.gov Identifier: NCT06036524
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : February 12, 2024
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Yong Wang, Washington University School of Medicine

Study Description
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Brief Summary:
The goal of this study is to develop new imaging biomarkers for quantitative assessments of myofascial pain.

Condition or disease Intervention/treatment Phase
Myofascial Pain Diagnostic Test: Multi-modal, multi-parametric, multiscale imaging of the myofascial unit Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a two-phase, NIH-supported study. The first R61 phase (currently awarded) is an observational study with one control group and one patient group. The second R33 phase is a randomized clinical trial, which will be awarded by the end of the R61 phase. The study design provided here is for R61 only.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain
Actual Study Start Date : October 24, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 60 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036524


Locations
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United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robin Haverman    314-747-1624    rlhaverman@wustl.edu   
Principal Investigator: Yong Wang, PhD         
Principal Investigator: Song Hu, PhD         
Sponsors and Collaborators
Washington University School of Medicine
National Center for Complementary and Integrative Health (NCCIH)
More Information
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Responsible Party: Yong Wang, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT06036524    
Other Study ID Numbers: 202201039
R61AT012283 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: February 12, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yong Wang, Washington University School of Medicine:
Magnetic Resonance Imaging
Surface Electromyography
Fiber-optic Imaging and Sensing
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases