xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036524</url>
    </required_header>
    <id_info>
      <org_study_id>202201039</org_study_id>
      <secondary_id>R61AT012283</secondary_id>
      <nct_id>NCT06036524</nct_id>
    </id_info>
    <brief_title>Multi-modal Imaging of Myofascial Pain</brief_title>
    <official_title>Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Washington University School of Medicine</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to develop new imaging biomarkers for quantitative assessments of&#xD;
        myofascial pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to develop a multi-modal, multi-parametric, multi-scale imaging of the human&#xD;
        myofascial unit by combining magnetic resonance imaging (MRI), surface electromyography&#xD;
        (sEMG), and fiber-optic imaging and sensing.&#xD;
  &#xD;
        Participants (half with active neck/shoulder/back pain, and half healthy controls) will be&#xD;
        recruited from pain management clinics and Volunteer for Health, or will be referred by Dr.&#xD;
        Xioabin Yi. They will undergo all three imaging techniques and complete a number of patient&#xD;
        questionnaires over the course of a single study visit. The study team will then identify&#xD;
        candidate biomarkers capable of differentiating between healthy (no myofascial pain) and&#xD;
        those with active pain to target in a future clinical trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Statistical Plan</measure>
      <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 &lt;20 minutes.</time_frame>
      <description>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 &gt;0.9, the proposed sample size can achieve a statistical power greater than 0.8.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Myofascial Pain</condition>
    <arm_group>
      <arm_group_label>Multi-modal imaging of myofascial pain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Multi-modal, multi-parametric, multiscale imaging of the myofascial unit</intervention_name>
      <description>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.</description>
      <arm_group_label>Multi-modal imaging of myofascial pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Healthy Volunteer Inclusion Criteria:&#xD;
  &#xD;
            1. Absence of a history of chronic pain in the targeted anatomical location (i.e., neck&#xD;
               and shoulder) that had limited activities of daily living or work&#xD;
  &#xD;
            2. A numerical current pain index of lower than 0.5 according to initial assessment with&#xD;
               visual analog scale&#xD;
  &#xD;
            3. Able to understand the goal of the project and give informed consent.&#xD;
  &#xD;
          Healthy Volunteer Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy or breastfeeding&#xD;
  &#xD;
            2. Contraindication to MRI&#xD;
  &#xD;
            3. Previous severe/acute neck or shoulder injury&#xD;
  &#xD;
            4. Previous neck or shoulder surgery&#xD;
  &#xD;
            5. Neck or shoulder deformities&#xD;
  &#xD;
            6. Inability to provide consent.&#xD;
  &#xD;
          Myofascial Pain Patient Inclusion Criteria:&#xD;
  &#xD;
            1. Between the ages of 18 and 60 years old&#xD;
  &#xD;
            2. Neck and/or shoulder pain, unilateral or bilateral&#xD;
  &#xD;
            3. Duration of symptoms for longer than 4 weeks&#xD;
  &#xD;
            4. Pain scale at the active state higher than 4 according to initial assessment with&#xD;
               visual analog scale&#xD;
  &#xD;
            5. Presence of active trigger point(s) according to palpation and/or presence of taut&#xD;
               band&#xD;
  &#xD;
          Myofascial Pain Patient Exclusion Criteria:&#xD;
  &#xD;
            1. Recent history of trauma to the neck (e.g., whiplash)&#xD;
  &#xD;
            2. Acute cervical radiculopathy&#xD;
  &#xD;
            3. Acute cervical spine pain component or acute cervical spinal pathology Presence of&#xD;
               neuromuscular pathologies or inflammatory muscle diseases (e.g., dermatomyositis)&#xD;
  &#xD;
            4. Systemic disease with diffuse body pain (e.g., system lupus erythematosus and and&#xD;
               thyroid disease)&#xD;
  &#xD;
            5. Peripheral neuropathy&#xD;
  &#xD;
            6. Cancer-related pain&#xD;
  &#xD;
            7. Pregnancy, coagulopathy, fever, general/local infection at the pain site, substance&#xD;
               abuse, peripheral neuropathy, or any other diseases that may account for signs and&#xD;
               symptoms mimicking myofascial pain&#xD;
  &#xD;
            8. Contraindication to MRI.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Washington University</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Robin Haverman</last_name>
        <phone>314-747-1624</phone>
        <email>rlhaverman@wustl.edu</email>
      </contact>
      <investigator>
        <last_name>Yong Wang, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Song Hu, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
      <investigator_full_name>Yong Wang</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Magnetic Resonance Imaging</keyword>
    <keyword>Surface Electromyography</keyword>
    <keyword>Fiber-optic Imaging and Sensing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036524
  org study id: 202201039
  secondary id: R61AT012283
  nct id: NCT06036524
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to develop new imaging biomarkers for quantitative assessments of
        myofascial pain.
  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.
  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.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: 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.
  description: 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.
  arm group label: Multi-modal imaging of myofascial pain
  arm group type: Experimental
  description: 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.
  intervention type: Diagnostic Test
  intervention name: Multi-modal, multi-parametric, multiscale imaging of the myofascial unit
  description: 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.
  arm group label: Multi-modal imaging of myofascial pain
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Washington University School of Medicine
  investigator full name: Yong Wang
  investigator title: Principal Investigator
  mesh term: Myofascial Pain Syndromes
  sharing ipd: No