Recruiting

Tuina Therapy

Sponsor:

Mayo Clinic

Code:

NCT07278570

Conditions

Myofascial Pain Syndrome - Lower Back

Myofascial Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tuina treatment

Usual care

Study Details

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.

Conditions

Myofascial Pain Syndrome - Lower Back

Myofascial Pain

Study ID

NCT07278570

Start date

Feb 1, 2026

Status verified date

Aug, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tuina + Usual Care

Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care.

active comparator: Usual Care Only

Participants will receive usual care only for three weeks, no additional manual therapy will be provided.

Interventions

Tuina 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.

Usual care

Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.

Primary outcome measure

  • Change in Pain, Enjoyment, and General Activity (PEG) score [ Time Frame: Baseline, 1 day post-intervention, 3 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Melissa L Bush

507-266-1008Bush.Melissa1@mayo.edu

Locations

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Melissa Bush

5072661008bush.melissa1@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.