Study Results
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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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-12-15
2026-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
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.
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.
Direct person massage therapy
Clinical massage treatment procedures are delivered by a clinically licensed massage therapist. This treatment will last approximately 20 minutes.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Michael R. Mueller
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
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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25-002863
Identifier Type: -
Identifier Source: org_study_id
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