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| ID | Type | Description | Link |
|---|---|---|---|
| R61AT012185 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with myofascial-related pain diseases | Experimental | Subjects diagnosed with myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging. |
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| Healthy controls without myofascial-related pain diseases | Experimental | Subjects without myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance (MR) Elastography | Diagnostic Test | Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Healthy Volunteer Inclusion Criteria:
Healthy Volunteer Exclusion Criteria:
Myofascial-Related Pain Patient Inclusion Criteria:
Myofascial-Related Pain Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziying Yin, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| MRI structural imaging | Diagnostic Test | MRI structural imaging will be done at the same time as MR elastography. |
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| D014463 |
| Ultrasonography |