Using MR elastography to track how manual therapy changes painful lower-back tissues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Patient Inclusion Criteria:

1. Adult males or females (age ≥ 18 years)
2. A history of chronic low back for at least 3 months. (Measured by patient history and physical exam)
3. A palpable taut band or nodule within the skeletal muscle
4. Hypersensitive tender spot within the taut band
5. Recognition of current pain complaint by pressure on the tender nodule/taut band
6. Painful limit to the full stretch range of motion

Patient Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan
3. Previous therapy in the area to be treated within 3 months
4. Previous severe back injury (including fracture) or surgery
5. Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
6. Severe osteoarthritis
7. Skin injuries in the area to be treated
8. 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.
9. Have a known history of any condition or factor judged by the investigators to preclude participation in the study or which might hinder adherence
10. Inability to provide consent.

Where it's running

• Mayo Clinic Rochester
  Rochester, Minnesota, United States Recruiting
• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Enrolling by invitation

Study contacts

• Principal investigator: Ziying Yin, Ph.D. — Mayo Clinic
• Study coordinator: Melissa L Bush
• Email: Bush.Melissa1@mayo.edu
• Phone: 507-266-1008

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.