Recruiting

EMMA vs. Massage Therapist

Sponsor:

Mayo Clinic

Code:

NCT07040397

Conditions

Lower Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EMMA massage therapy

Clinical massage treatment

Study Details

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

Study ID

NCT07040397

Start date

Jan 30, 2026

Status verified date

Apr, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Direct person massage therapy

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

Interventions

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.

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.

Primary outcome measure

  • Number of patients enrolled [ Time Frame: baseline to end of study (year 2) ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Pearl Buabeng

507-266-1213GIMResearchStudies@Mayo.edu

Principal Investigator:

Michael Mueller

More Information

Sponsor

Mayo Clinic

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-04.