Electronic Approach to the Human Massage Therapist

NCT07040397 | Recruiting FDA Device

• 1 other identifier: 25-002863
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Back Pain

Keywords

massage; Low Back Pain; automated massage; EMMA (expert manipulative massage automation); electric massager

Outcome Measures

Primary Outcomes (1)

• Number of patients enrolled

  Feasibility will be determined by the total number of patients screened in order to accrue the 40 needed to complete the study.

  baseline to end of study (year 2)

Study Arms (2)

Indirect person massage therapy

EXPERIMENTAL

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.

Device: EMMA massage therapy

Direct person massage therapy

ACTIVE COMPARATOR

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

Other: Clinical massage treatment

Interventions

EMMA massage therapy DEVICE

Expert Manipulative Massage Automation (EMMA) is equipped with sensors to measure muscle stiffness and uses 3D vision technology to measure muscle stiffness and identify pressure points while delivering a massage to patients. Following that, the electronic massager will determine the best course of action for our patients based on the information stored by our Artificial Intelligence and EMMA's robotic arm will perform the massage. EMMA executes massages through soft treatment modules that are warmed to a temperature of between 38℃ and 40℃ to mimic human touch.

Indirect person massage therapy

Clinical massage treatment OTHER

The direct person clinical massage treatment will be delivered by a clinical licensed massage therapist. The type of massage will follow the EMMA massage in that it will be a deep tissue massage (to mimic the Tuina massage) and generally will be for about 30 minutes to once again mimic the duration of massage therapy of the EMMA.

Direct person massage therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Mueller

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 20 will be randomized to EMMA and 20 to a certified massage therapist. Everyone will receive a massage treatment.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 27, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)