Chronic Low Back Pain (CLBP), Low Back Pain, Recurrent
Conditions
Brief 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.
Interventions
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SII-derived mobility index | Baseline, 30 minutes post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain, Enjoyment of Life, and General Activity (PEG) Scale Score | 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. |
| Change in Spinal Range of Motion (ROM) | 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. |
Countries
United States
Contacts
CONTACTMelissa Bush
PRINCIPAL_INVESTIGATORZiying Yin, Ph.D.
Mayo Clinic
Outcome results
None listed