Robotic EMMA versus therapist-delivered lower back massage
Comparing an Electronic Approach to the Human Massage Therapist.
This test compares a robotic device called EMMA to a certified massage therapist for adults with lower back pain to see if patient experience differs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07040397 on ClinicalTrials.gov |
What this trial studies
Outpatient adults with a primary complaint of lower back pain are enrolled and randomized to receive either hands-on massage from a certified massage therapist or an EMMA (Expert Manipulative Massage Automation) massage operated by a certified therapist. Baseline pain intensity is recorded and participants must meet standard safety and positioning criteria. The study collects patient-reported experience and tolerability data after the assigned massage session. All procedures are performed at a single Mayo Clinic location in Rochester, Minnesota.
Who should consider this trial
Good fit: Adults 18 or older with a primary lower back pain complaint who can lie prone, are not pregnant or breastfeeding, can provide informed consent, and meet the other listed safety criteria are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, cannot remain prone, have bleeding disorders, local skin allergies/affectations, implanted devices in the massage area, or who used pain treatments or investigational drugs within the exclusion windows may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could expand access to standardized massage care and offer a consistent, technology-assisted option for people with lower back pain.
How similar studies have performed: Automated massage devices have been tested in small studies with mixed results, and direct randomized comparisons to therapist-delivered massage remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * be 18 years of age or older. * report a primary pain point in the lower back. * Pain intensity reported at baseline * Women of childbearing potential who self-report not being pregnant and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period * 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 position * Patients with bleeding disorders * Patients with allergies and/or local skin affectations * have used pain medications or participated in a pain treatment within three days of study enrollment. * have an implanted device (including a lap band) in the targeted area of massage therapy. * have used an investigational drug within 30 days of study enrollment. * have a 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. * have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as uncontrolled diabetes type 2) active cancer, actively receiving treatment for cancer or within 1 year of cancer remission. * surgical intervention for pain within 1 month prior to enrollment. * active infection, wound or other external trauma to the areas to be treated with massage therapy. * have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael Mueller — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.