Magnetic Resonance Elastography Of Chronic Low Back Pain Before And After Therapy

NCT ID
NCT07712458
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Mayo Clinic
Conditions
Chronic Low Back Pain (CLBP), Low Back Pain, Recurrent

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Magnetic Resonance Elastography Assessment Of Chronic Low Back Pain Before And After A Manual Therapy Intervention

Enrollment: 38 participants (Estimated).

What is being studied

  • Device: EMMA (Expert Manipulative Massage Automation)

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Minnesota, United States: 1

Sample of listed locations

  • Mayo Clinic in Rochester — Rochester, Minnesota, 55905, United States — Site recruitment status not specified in the registry data

Study details

Start date
November 1, 2026
Primary completion date
January 1, 2028
Completion date
August 1, 2028
First posted
July 17, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07712458
Registry last updated
September 17, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07712458 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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