Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07278570
Status
Recruiting
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Conditions

  • Myofascial Pain
  • Myofascial Pain Syndrome - Lower Back

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tuina treatment — OTHER
    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 — OTHER
    Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.

Study Details

The purpose of this research is to develop and test new Magnetic Resonance Imaging (MRI) methods that look at how muscles and tissues under the skin (myofascial tissues) move and respond to pressure. The investigators want to see how these tissues differ between healthy people and people with pain or injury, and how they change after hands-on treatment (Tuina therapy). The results will also be compared to a group that receives standard care without Tuina therapy. 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.

Key Dates

Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tuina + Usual Care
    Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care.
  • Active Comparator: Usual Care Only
    Participants will receive usual care only for three weeks, no additional manual therapy will be provided.

Primary Outcome Measure

Change in Pain, Enjoyment, and General Activity (PEG) score [ Time Frame: Baseline, 1 day post-intervention, 3 weeks post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-
Mayo Clinic RochesterRochesterMinnesota55905
Melissa Bush
[email protected]
5072661008

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