Myofascial Pain, Myofascial Pain Syndrome - Lower Back
Conditions
Brief summary
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
OTHERTuina 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.
OTHERUsual care
Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.
Sponsors
Mayo Clinic
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain, Enjoyment, and General Activity (PEG) score | Baseline, 1 day post-intervention, 3 weeks post-intervention | 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 |
Countries
United States
Contacts
CONTACTMelissa L Bush
PRINCIPAL_INVESTIGATORZiying Yin, Ph.D.
Mayo Clinic
Outcome results
None listed