Magnetic Resonance Elastography of Myofascial Pain Syndrome

Myofascial Pain Clinical Trial

Official title:

Magnetic Resonance Elastography of Myofascial Pain Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05604066
• Other study ID #: 22-007647
• Secondary ID: R61AT012185
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 106
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Exclusion Criteria:

• Pregnancy or breastfeeding
• Any contraindication to an MRI exam
• Previous therapy in the area to be treated within 6 months
• Previous severe back or low extremity injury (including fracture) or surgery
• Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
• Severe osteoarthritis
• Skin injuries in the area to be treated
• Inability to provide consent.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain
• Myofascial Pain Syndromes

Intervention

Diagnostic Test:
• Magnetic Resonance (MR) Elastography
Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues
• MRI structural imaging
MRI structural imaging will be done at the same time as MR elastography.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	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	The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements	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.	baseline measures through the study completion (3 years)

External Links

•   Mayo Clinic Clinical Trials