Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain
Recruiting · NCT07278570 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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.
Where it is running
2 locations listed across 1 US state.
- Mayo Clinic in Rochester - Rochester, Minnesota, United States
- Mayo Clinic Rochester - Rochester, Minnesota, United States