Clinical trial NCT05604066: Magnetic Resonance Elastography of Myofascial Pain Syndrome
Official title: Magnetic Resonance Elastography of Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myofascial Pain
Keywords: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Elastography (MRE)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-11-03
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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 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.

Primary outcomes:
measure: The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements
timeFrame: baseline measures through the study completion (3 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ziying Yin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: