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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain, Recurrent; Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Device: EMMA (Expert Manipulative Massage Automation)

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Bush; Phone Number: 507-266-1008; Email: Bush.Melissa1@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expert Manipulative Massage Automation (EMMA); Subjects will receive one massage therapy session utilizing the EMMA system	Device: EMMA (Expert Manipulative Massage Automation); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in SII-derived mobility index	Baseline, 30 minutes post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 30 minutes post-intervention

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ziying Yin, Ph.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: 26-002257; INTERSHIELD 26-002257 (Other Grant/Funding Number: Mayo Clinic Radiology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No