Actively Recruiting
Comparing an Electronic Approach to the Human Massage Therapist for Lower Back Pain
Led by Mayo Clinic · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare patient experiences receiving massage therapy for lower back pain using a robotic device called EMMA (Expert Manipulative Massage Automation) versus a traditional massage therapist. The study focuses on individuals reporting primary pain in the lower back, exploring how these two methods of massage therapy differ in patient response and experience. Participants will be randomly assigned to one of two groups: one receiving massage therapy delivered by EMMA, a robotic arm guided by artificial intelligence and operated by a certified massage therapist; the other receiving a direct massage from a licensed massage therapist. EMMA performs massages using warmed soft treatment modules to mimic human touch, while the human massage lasts about 30 minutes mimicking EMMA's deep tissue style. Both treatments last approximately 20 to 30 minutes. During the study, participants' pain intensity and other responses will be monitored. The primary outcome is the number of patients enrolled from the start to the end of the two-year study period. Participants will be assessed for eligibility, provide consent, and will participate fully in all study aspects. Safety and adherence will be observed throughout the study duration ending in October 2026.
CONDITIONS
Brief Title
Electronic Approach to the Human Massage Therapist
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older.
- Report a primary pain point in the lower back.
- Report pain intensity at baseline.
- Women of childbearing potential must self-report not being pregnant and agree to use effective birth control during the study.
- Be able to participate fully in all aspects of the study.
- Have understood and signed study informed consent.
You will not qualify if you...
- Pregnancy or breastfeeding.
- Inability to stay in a prone (face down) position.
- Bleeding disorders.
- Allergies and/or local skin conditions.
- Use of pain medications or participation in pain treatment within three days of study enrollment.
- Implanted device in the targeted massage area.
- Use of investigational drug within 30 days of enrollment.
- History of major cardiovascular events or serious heart conditions.
- Clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease.
- Active cancer, receiving cancer treatment, or within one year of cancer remission.
- Surgical intervention for pain within one month prior to enrollment.
- Active infection, wound, or trauma in the massage area.
- Any other condition judged by the investigator to prevent study participation or adherence.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 minutes per session
Participants receive massage therapy either by a certified massage therapist or by the EMMA robotic massage device.
1 treatment visit
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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