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

Mayo Clinic

Status: Enrolling

Conditions: Myofascial Pain Syndrome - Lower Back; Myofascial Pain

Treatments: Other: Tuina treatment; Other: Usual care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07278570

25-009844

4R33AT012185-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Tuina + Usual Care

Experimental group

Description:

Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care.

Treatment:

Other: Usual care

Other: Tuina treatment

Usual Care Only

Active Comparator group

Description:

Participants will receive usual care only for three weeks, no additional manual therapy will be provided.

Treatment:

Other: Usual care