Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain
NCT ID: NCT07278570
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
78 participants
INTERVENTIONAL
2026-01-05
2027-08-30
Brief Summary
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The main questions this study aims to answer are:
1. Can MR elastography (MRE) show changes in how the fascia and the layers between muscles move and stretch before and after manual therapy?
2. Do changes seen on MRE scans match changes in pain, function, and other symptoms reported by participants?
3. Can MRE measurements before treatment help predict which participants are most likely to improve with manual therapy?
In this randomized controlled trial, participants with myofascial pain will be randomly assigned (randomized) to either the Tuina group or the Usual Care group following a home-based care program without manual therapy. All treatments are noninvasive, hands-on techniques commonly used in clinical practice to reduce tissue tightness and improve movement.
Participants will be asked to undergo three MRI scans and to complete questionnaires and other standard clinical assessments about their pain, physical function, and quality of life.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tuina + Usual Care
Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care.
Tuina treatment
Tuina is a manual therapy involving techniques that apply targeted shear and stretching forces along muscular and fascial planes. Tuina therapy will be administered to subjects twice weekly for three consecutive weeks (a total of six sessions). Each session will last 30-60 minutes and will be administered by licensed Tuina practitioners trained and credentialed at Mayo Clinic.
Usual care
Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.
Usual Care Only
Participants will receive usual care only for three weeks, no additional manual therapy will be provided.
Usual care
Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.
Interventions
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Tuina treatment
Tuina is a manual therapy involving techniques that apply targeted shear and stretching forces along muscular and fascial planes. Tuina therapy will be administered to subjects twice weekly for three consecutive weeks (a total of six sessions). Each session will last 30-60 minutes and will be administered by licensed Tuina practitioners trained and credentialed at Mayo Clinic.
Usual care
Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.
Eligibility Criteria
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Inclusion Criteria
* A history of chronic low back 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
Exclusion Criteria
* Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan
* Previous therapy in the area to be treated within 3 months
* Previous severe back 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.
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Mayo Clinic
OTHER
Responsible Party
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Ziying Yin
Principal Investigator
Principal Investigators
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Ziying Yin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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NCT05604066 - Magnetic Resonance Elastography of Myofascial Pain Syndrome
Other Identifiers
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25-009844
Identifier Type: -
Identifier Source: org_study_id