Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tuina treatment, Usual care.
- Who it may be relevant to
- Registry conditions: Myofascial Pain Syndrome - Lower Back, Myofascial Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Other 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. - Other Usual care
Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.
Primary outcome measures
- Change in Pain, Enjoyment, and General Activity (PEG) score [Time frame: Baseline, 1 day post-intervention, 3 weeks post-intervention]
Eligibility criteria
Patient 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
Patient 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
- Known or suspected clinically significant lumbar disc or other structural spinal pathology considered to be the primary cause of the participant's symptoms or makes study participation or manual therapy inappropriate.
- Have a known history of any condition or factor judged by the investigators to preclude participation in the study or which might hinder adherence
- Inability to provide consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Mayo Clinic in Rochester — Rochester
- Mayo Clinic Rochester — Rochester
Identifiers
NCT: NCT07278570 · 25-009844 · 4R33AT012185-02