Electronic Approach to the Human Massage Therapist

Mayo Clinic

Status: Begins enrollment this month

Conditions: Lower Back Pain

Treatments: Other: Clinical massage treatment; Device: EMMA massage therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07040397

25-002863

Details and patient eligibility

About

The purpose of this study is to gather information about patient experience receiving a massage through a robotic EMMA (Expert Manipulative Massage Automation) compared to receiving a massage from a massage therapist.

Full description

Patients being evaluated in an outpatient service will be invited to participate in this study if they report a primary pain point in Low Back. Once they are enrolled in the study, they will be randomized to the type of massage therapy they will receive. Direct massage therapy through a certified massage therapist or indirect massage therapy through EMMA operated by a certified massage therapist.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Indirect person massage therapy

Experimental group

Description:

A massage therapist will program and direct an Artificial Intelligence Robotic Arm (EMMA) to deliver massage therapy. EMMA executes massages through soft treatment modules that are warmed to a temperature of between 38℃ and 40℃ to mimic human touch. This treatment will last approximately 20 minutes.

Treatment:

Device: EMMA massage therapy

Direct person massage therapy

Active Comparator group

Description:

Clinical massage treatment procedures are delivered by a clinically licensed massage therapist. This treatment will last approximately 20 minutes.

Treatment:

Other: Clinical massage treatment