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NCT Number: NCT07712458

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in SII-derived mobility index

    Time frame: Baseline, 30 minutes post-intervention

Secondary outcomes

  1. Change in Pain, Enjoyment of Life, and General Activity (PEG) Scale Score

    Time frame: Baseline, 30 minutes post-intervention

    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.

  2. Change in Spinal Range of Motion (ROM)

    Time frame: Baseline, 30 minutes post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Bush

CONTACT

[email protected]

507-266-1008

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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