Multi-modal Imaging of Myofascial Pain

Myofascial Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036524
• Other study ID #: 202201039
• Secondary ID: R61AT012283
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.