Myofascial Pain Syndrome - Lower BackNCT07278570
Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain
A study testing Tuina treatment in people with Myofascial Pain Syndrome - Lower Back and Myofascial Pain, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome - Lower Back, Myofascial Pain
- What is being tested?
- Tuina treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2026to 30 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Enrolling by invitation
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Melissa Bush, 5072661008, bush.melissa1@mayo.edu
About this study
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:
Read more
- Can MR elastography (MRE) show changes in how the fascia and the layers between muscles move and stretch before and after manual therapy?
- Do changes seen on MRE scans match changes in pain, function, and other symptoms reported by participants?
- 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.
Read the 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.
- Being tested
- Tuina treatment, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuina treatmentOther
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.
Usual careOther
Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.
| Study group | Role | What they receive |
|---|---|---|
| Tuina + Usual Care | Experimental | Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care. Receives: Other: Tuina treatment; Other: Usual care |
| Usual Care Only | Active comparator | Participants will receive usual care only for three weeks, no additional manual therapy will be provided. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1 day post-intervention, 3 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Feb 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome - Lower BackStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ziying Yin, Mayo Clinic
- Investigators
- Ziying Yin, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278570
- Sponsor's protocol ID
- 25-009844
- Other IDs
- 4R33AT012185-02
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No