Multi-modal Imaging of Myofascial Pain

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06036524

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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.

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

Primary Outcome Measures

Statistical Plan [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

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine
National Center for Complementary and Integrative Health (NCCIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yong Wang, Principal Investigator, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT06036524

Other Study ID Numbers:

202201039
R61AT012283

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yong Wang, Principal Investigator, Washington University School of Medicine

Magnetic Resonance Imaging

Surface Electromyography

Fiber-optic Imaging and Sensing

Additional relevant MeSH terms:

Myofascial Pain Syndromes

Study Results

No Results Posted as of Sep 14, 2023