Electronic Approach to the Human Massage Therapist

NCT ID: NCT07040397

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lower Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

20 will be randomized to EMMA and 20 to a certified massage therapist. Everyone will receive a massage treatment.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Indirect person massage therapy

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.

Group Type EXPERIMENTAL

EMMA massage therapy

Intervention Type 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.

Direct person massage therapy

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

Group Type ACTIVE_COMPARATOR

Clinical massage treatment

Intervention Type 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.

Interventions

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EMMA massage therapy

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.

Intervention Type DEVICE

Clinical massage treatment

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Michael R. Mueller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Mueller

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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25-002863

Identifier Type: -

Identifier Source: org_study_id

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