Robotic EMMA versus therapist-delivered lower back massage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Michael Mueller — Mayo Clinic

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.