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Multi-modal Imaging of Myofascial Pain

Primary Purpose

Myofascial Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-modal, multi-parametric, multiscale imaging of the myofascial unit
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myofascial Pain focused on measuring Magnetic Resonance Imaging, Surface Electromyography, Fiber-optic Imaging and Sensing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 60 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.

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multi-modal imaging of myofascial pain

Arm 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.

Outcomes

Primary Outcome Measures

Statistical Plan
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2023
Last Updated
September 6, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT06036524
Brief Title
Multi-modal Imaging of Myofascial Pain
Official Title
Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain
Keywords
Magnetic Resonance Imaging, Surface Electromyography, Fiber-optic Imaging and Sensing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-modal imaging of myofascial pain
Arm Type
Experimental
Arm 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(s)
Multi-modal, multi-parametric, multiscale imaging of the myofascial unit
Intervention 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.
Primary Outcome Measure Information:
Title
Statistical Plan
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 60 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.
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Haverman
Phone
314-747-1624
Email
rlhaverman@wustl.edu
First Name & Middle Initial & Last Name & Degree
Yong Wang, PhD
First Name & Middle Initial & Last Name & Degree
Song Hu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi-modal Imaging of Myofascial Pain

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