About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Tuina treatment
Other interventionTuina 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.
Usual care
Other interventionStandard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.
Treatment groups
Trial outcomes
Primary outcomes
Change in Pain, Enjoyment, and General Activity (PEG) score
The Pain, Enjoyment, and General Activity (PEG) score is a three-item questionnaire asking individuals to rate their Pain, Enjoyment of life, and General activity on a scale of 0 to 10 over the past week. The PEG score is the average of the three responses, ranging from 0 to 10, with higher scores indicating more severe pain or interference with life
Sponsors and contacts
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Mayo Clinic
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator