Myofascial PainNCT05604066
Magnetic Resonance Elastography of Myofascial Pain Syndrome
A study testing Magnetic Resonance (MR) Elastography and MRI structural imaging in people with Myofascial Pain, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- Magnetic Resonance (MR) Elastography and MRI structural imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Myofascial Pain
- Being tested
- Magnetic Resonance (MR) Elastography, MRI structural imaging
- Keywords
- Magnetic Resonance Imaging (MRI), Magnetic Resonance Elastography (MRE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance (MR) ElastographyDiagnostic test
Also called MRE
Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues
MRI structural imagingDiagnostic test
Also called MRI
MRI structural imaging will be done at the same time as MR elastography.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Magnetic Resonance (MR) Elastography; Diagnostic Test: MRI structural imaging |
| 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. Receives: Diagnostic Test: Magnetic Resonance (MR) Elastography; Diagnostic Test: MRI structural imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline measures through the study completion (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start13 Apr 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ziying Yin, Mayo Clinic
- Investigators
- Ziying Yin, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604066
- Sponsor's protocol ID
- 22-007647
- Other IDs
- R61AT012185
- Status last verified
- Oct 2025
- First submitted
- 24 Oct 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography of Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05604066
- Acronym / sponsor ID
- 22-007647
- Conditions
- Myofascial Pain
- Keywords
- Magnetic Resonance Imaging (MRI), Magnetic Resonance Elastography (MRE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with myofascial-related pain diseases | Experimental | Diagnostic Test: Magnetic Resonance (MR) Elastography, Diagnostic Test: MRI structural imagingSubjects diagnosed with myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging. |
| Healthy controls without myofascial-related pain diseases | Experimental | Diagnostic Test: Magnetic Resonance (MR) Elastography, Diagnostic Test: MRI structural imagingSubjects without myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance (MR) ElastographyAlso: MREMagnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues | Diagnostic test | Healthy controls without myofascial-related pain diseases, Patients with myofascial-related pain diseases |
| MRI structural imagingAlso: MRIMRI structural imaging will be done at the same time as MR elastography. | Diagnostic test | Healthy controls without myofascial-related pain diseases, Patients with myofascial-related pain diseases |
Primary outcome
The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziying Yin, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance (MR) Elastography and MRI structural imaging in people with Myofascial Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements (time frame: baseline measures through the study completion (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.