Myofascial Pain
Conditions
Keywords
Magnetic Resonance Imaging (MRI), Magnetic Resonance Elastography (MRE)
Brief summary
The purpose of this research study is to use a new imaging technique called Magnetic Resonance (MR) Elastography to create new imaging parameters to measure the mechanical properties of myofascial tissues that can be used to assess the impaired myofascial interface in myofascial pain syndrome (MPS).
Detailed description
This is observational research that aims to develop an MRI-based imaging technique (MRE) to quantitatively assess the myofascial tissue properties in healthy subjects and patients with relevant pain conditions. Healthy volunteers and patients with MPS will be recruited to undergo MRI along with MR elastography.
Interventions
DIAGNOSTIC_TESTMagnetic Resonance (MR) Elastography
Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues
DIAGNOSTIC_TESTMRI structural imaging
MRI structural imaging will be done at the same time as MR elastography.
Sponsors
Mayo Clinic
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a two-phase NIH-awarded 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 pilot clinical trial, which will be awarded by the end of the R61 phase. The study design provided here is for R61 only.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteer Inclusion Criteria: * Absence of a history of chronic pain in the targeted anatomical location (i.e., lower back and low extremities) that had limited activities of daily living or work * A numerical current pain index of less than 0.5 (on a 10-point Visual Analog Scale) * Able to understand the goal of the project and give informed consent. Healthy Volunteer
Exclusion criteria
* Pregnancy or breastfeeding * Any contraindication to an MRI exam * Previous severe/acute back or low extremity injury (including fracture) * Previous back or low extremity surgery * Back and lower limb deformities * Inability to provide consent. Myofascial-Related Pain Patient Inclusion Criteria: * A history of chronic low back or leg pain (the targeted location will be determined based on the findings in Aim 1) for at least 3 months. (Measured by patient history and physical exam) * A palpable taut band or nodule within the skeletal muscle * Hypersensitive tender spot within the taut band * Recognition of current pain complaint by pressure on the tender nodule/taut band * Painful limit to the full stretch range of motion Myofascial-Related Pain Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements | baseline measures through the study completion (3 years) | In response to an external shear force, the fascial layers that surround and separate muscles can deform or slide relative to each other, depending on the fascial plane's mobility. An adhesive interface that experiences a shear force will exhibit shear displacement continuity (i.e., small shear strain) across the interface, while a nonadhesive interface may slip rather than deform, which causes a discontinuity in displacement (i.e., large shear strain). For the targeted fascia plane in low back and legs, the normalized octahedral shear strain (NOSS) will be computed from the shear displacement data measured from MRE to assess the fascia plane mobility. The primary outcome measure is the difference in the fascia plane mobility on MR elastography between patients with myofascial-related pain diseases and healthy controls without myofascial-related pain diseases. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZiying Yin, Ph.D.
Mayo Clinic
Outcome results
None listed