Satisfaction and Feasibility Evaluation of an Electronic Massager Compared to Massage Therapist-delivered Massage

NCT07042776 | Recruiting FDA Device

• 1 other identifier: 25-002916
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the practicality and acceptability of using an electronic massager. Additionally, it aims to compare user satisfaction between the experience with an electric massager and a massage provided by a professional massage therapist.

Conditions

Massage Therapy

Keywords

EMMA; Expert Manipulative Massage Automation; Massage Therapy; EMMA@TREATMENT

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.

  Duration of study, approximately 2 years

Study Arms (2)

EMMA treatment, then therapist-delivered massage

EXPERIMENTAL

Subjects in this arm will first undergo massage therapy utilizing the EMMA Massager (Expert Manipulative Massage Automation). A minimum of 24 hours later, the subjects will undergo a massage therapist-delivered massage.

Device: EMMA (Expert Manipulative Massage Automation); Other: Therapist-delivered massage

Therapist-delivered massage, then EMMA treatment

EXPERIMENTAL

Subjects in this arm will first undergo a massage therapist-delivered massage treatment. A minimum of 24 hours later, the subjects will undergo massage therapy utilizing the EMMA Massager (Expert Manipulative Massage Automation).

Device: EMMA (Expert Manipulative Massage Automation); Other: Therapist-delivered massage

Interventions

Therapist-delivered massage OTHER

For the therapist-delivered massage treatment, the licensed massage therapist will follow standard of care protocol. Treatment lasts approximately 20-30 minutes.

EMMA treatment, then therapist-delivered massage; Therapist-delivered massage, then EMMA treatment

EMMA (Expert Manipulative Massage Automation) DEVICE

For the EMMA massage, the subject lies down on the robot platform in a prone position. A therapist sets the robot parameters. The EMMA electronic massager applies massage to the focus points on the back of the participants guided by cameras and computer programs. Treatment lasts approximately 20-30 minutes.

EMMA treatment, then therapist-delivered massage; Therapist-delivered massage, then EMMA treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Ability to provide informed consent
• 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
• Ability to complete all aspects of this trial

You may not qualify if:

• Pregnancy or breastfeeding
• Patients with inability of staying in a prone position
• Patients with bleeding disorders
• Patients with a current diagnosis of cancer or being treated for cancer
• Patients with allergies and/or local skin affectations
• An unstable medical or mental health condition as determined by the physician investigator

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Brent Bauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Fokken, CCRP

CONTACT

507-293-2740; GIMResearchStudies@mayo.edu

Study Design

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

Model Details: Two different massage therapies will be experienced by subjects: EMMA electronic massage and massage therapy by a massage therapist. The order in which the massages will be experienced will be determined by randomization.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 29, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)