Clinical trial NCT06036524: 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
Overall status: RECRUITING
Phase: NA
Conditions: Myofascial Pain
Keywords: Magnetic Resonance Imaging
Surface Electromyography
Fiber-optic Imaging and Sensing
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

Eligibility 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 80 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.

Primary outcomes:
measure: Statistical Plan
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References: