Using MR elastography to track how manual therapy changes painful lower-back tissues
Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain
This trial will see if a special MRI method (MR elastography) can show tissue changes in adults with chronic lower‑back myofascial pain after Tuina manual therapy compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT07278570 on ClinicalTrials.gov |
What this trial studies
Adults with chronic lower‑back myofascial pain will be randomized to receive a course of Tuina manual therapy or usual care, with MR elastography (MRE) scans performed before and after the treatment period. The trial will compare MRE measures of fascia and intramuscular layers to patient‑reported pain and function scores to look for matching changes. Investigators will also test whether baseline MRE measurements can predict who improves most with manual therapy. The MRE techniques and biomarkers used here were developed and validated in a prior linked study.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic (≥3 months) lower‑back myofascial pain characterized by a palpable taut band or tender nodule and pain on pressure are ideal candidates for this trial.
Not a fit: Patients with MRI contraindications, recent treatment in the target area, prior severe back injury or surgery, major neurological or systemic diseases, or pregnancy/breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide an objective MRI marker to show tissue changes and help guide whom manual therapy is most likely to help.
How similar studies have performed: A prior linked study developed and validated the MRE techniques and biomarkers used here, but using those biomarkers to predict response to manual therapy is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Enrolling_by_invitation)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ziying Yin, Ph.D. — Mayo Clinic
- Study coordinator: Melissa L Bush
- Email: Bush.Melissa1@mayo.edu
- Phone: 507-266-1008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.