Magnetic Resonance Elastography Of Chronic Low Back Pain Before And After Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
EMMA (Expert Manipulative Massage Automation)
DeviceParticipants 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.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: Expert Manipulative Massage Automation (EMMA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in SII-derived mobility index
Time frame
Baseline, 30 minutes post-interventionSecondary outcomes
1
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.
Time frame
Baseline, 30 minutes post-intervention2
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.
Time frame
Baseline, 30 minutes post-interventionSponsors and contacts
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Source ClinicalTrials.gov
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