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NCT Number: NCT07278570

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

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.

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Key information

Conditions

Myofascial Pain Syndrome - Lower Back Myofascial Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester, Rochester, Minnesota, United States

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About this study

This research study is linked to the prior study NCT05604066 (Magnetic Resonance Elastography of Myofascial Pain Syndrome), which developed and validated the MRE techniques and biomarkers used in the current trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult males or females (age ≥ 18 years)
  • 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

  • Pregnancy or breastfeeding
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Pain, Enjoyment, and General Activity (PEG) score

    Time frame: Baseline, 1 day post-intervention, 3 weeks post-intervention

    The Pain, Enjoyment, and General Activity (PEG) score is a three-item questionnaire asking individuals to rate their Pain, Enjoyment of life, and General activity on a scale of 0 to 10 over the past week. The PEG score is the average of the three responses, ranging from 0 to 10, with higher scores indicating more severe pain or interference with life

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa L Bush

CONTACT

[email protected]

507-266-1008

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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