Low Back Pain, RecurrentNCT07712458
Magnetic Resonance Elastography Of Chronic Low Back Pain Before And After Therapy
A study testing EMMA (Expert Manipulative Massage Automation) in people with Low Back Pain, Recurrent and Chronic Low Back Pain (CLBP), run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to quantify Magnetic Resonance Elastography (MRE)-derived mechanical property biomarkers of the lumbar paraspinal musculature and associated myofascial tissue regions before and after the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Recurrent, Chronic Low Back Pain (CLBP)
- What is being tested?
- EMMA (Expert Manipulative Massage Automation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Aug 2028
- 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
Who may be able to join
- Adult males or females (age ≥ 18 years)
- Report chronic low back pain (≥3 months) (measured by patient history and clinical evaluation)
- Pain intensity reported at baseline must be ≥4 on the pain VAS scale
- Presence of myofascial pain features in the lumbar region (e.g., localized tenderness and/or trigger points identified by a qualified clinician/therapist)
- Able to lie in supine and prone positions for study procedures
- Be able to participate fully in all aspects of the study
- Have understood and signed study informed consent
Who cannot join
- Pregnancy or breastfeeding
- Patients with the inability to stay in a prone and supine position for the required procedure durations (e.g., ≥30 minutes at a time)
- Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan
- Previous lumbar spine surgery or history of severe lumbar injury (e.g., fracture) that, in the investigation team's judgment, would interfere with participation or safety
- Patients with known bleeding disorders or current therapeutic anticoagulation that would increase risk of bruising/bleeding with massage
- Patients with skin conditions affecting the treatment area (e.g., rash, open wound, active dermatitis) or known allergy to any materials used during treatment (e.g., gels/cleaners), if applicable
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- Receipt of a new pain treatment within 3 days of the study visit (e.g., injection, ablation, spinal manipulation, massage/manual therapy) that could confound pre/post measures
- Use of short-acting opioid analgesics or sedating medications within 24 hours of the study visit
- Have an implanted device in or near the treatment area that could interfere with safe application of external pressure
- Have used an investigational drug within 30 days of study enrollment
- History of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
- Clinically significant unstable neurologic or systemic illness that would preclude safe participation, as judged by the investigation team.
- Surgical intervention for pain within 1 month prior to enrollment
- Active infection, wound, or other external trauma to the areas to be treated
- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
- Inability to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Magnetic Resonance Elastography Assessment Of Chronic Low Back Pain Before And After A Manual Therapy Intervention
The purpose of this study is to quantify Magnetic Resonance Elastography (MRE)-derived mechanical property biomarkers of the lumbar paraspinal musculature and associated myofascial tissue regions before and after the intervention.
- Being tested
- EMMA (Expert Manipulative Massage Automation)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMMA (Expert Manipulative Massage Automation)Device
Participants will receive device-assisted massage therapy using EMMA (Expert Manipulative Massage Automation). Each treatment session will last approximately 30 minutes. The device will be operated using conservative settings with predefined maximum force and pressure limits.
| Study group | Role | What they receive |
|---|---|---|
| Expert Manipulative Massage Automation (EMMA) | Experimental | Subjects will receive one massage therapy session utilizing the EMMA system Receives: Device: EMMA (Expert Manipulative Massage Automation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SII-derived mobility index
Measured: Baseline, 30 minutes post-intervention
Secondary outcomes (2)
Change in Pain, Enjoyment of Life, and General Activity (PEG) Scale Score
The Pain, Enjoyment of Life, and General Activity (PEG) scale is a 3-item participant-reported measure used to assess pain intensity and pain-related interference with enjoyment of life and general activity. The total PEG score is calculated as the average of the 3 item scores and ranges from 0 to 10, with higher scores indicating greater pain severity and interference.
Measured: Baseline, 30 minutes post-intervention
Change in Spinal Range of Motion (ROM)
Spinal range of motion will be assessed by a clinical assessor using a bubble inclinometer. Measurements will include lumbar flexion and right and left lateral bending. The outcome will be reported as the change from baseline in spinal range of motion, measured in degrees.
Measured: Baseline, 30 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, RecurrentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziying Yin, Mayo Clinic
- Investigators
- Ziying Yin, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712458
- Sponsor's protocol ID
- 26-002257
- Other IDs
- INTERSHIELD 26-002257
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No