EMMA Massage Therapy for Lower Back Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Pain medications

Disqualifiers: Pregnancy, Bleeding disorders, Cardiovascular events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how massages from a robotic arm, called EMMA, compare to those from a human therapist in relieving lower back pain. The goal is to understand how each type of massage affects patient experiences and outcomes. It may suit individuals who frequently experience lower back pain and can attend all sessions. Participants must not have used pain medication or received other pain treatments in the three days before the study begins. As an unphased trial, this study offers a unique opportunity to explore innovative massage technology and contribute to advancements in pain management.

Do I need to stop my current medications for the trial?

The trial requires that you have not used pain medications or participated in a pain treatment within three days before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What prior data suggests that the EMMA device is safe for massage therapy?

Research has shown that the EMMA massage device is generally safe and well-liked. One study found that healthy volunteers were very satisfied with the EMMA massager, indicating it is easy and comfortable to use. This feedback is important because it demonstrates that people can use the device without major problems. Although these studies report no specific negative effects, this absence of issues is a positive indicator for safety.

It is important to note that this trial is in a "not applicable" phase, which usually involves gathering basic information rather than testing a new drug's safety. This indicates that EMMA is not a new drug but a device, with safety focusing more on comfort and user experience. Overall, the available data suggests that EMMA massage therapy is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EMMA massage therapy for lower back pain because it introduces an innovative delivery method using an Artificial Intelligence Robotic Arm. Unlike traditional massage therapy, which relies solely on a human therapist, EMMA can mimic human touch with its soft, warmed treatment modules, providing consistent and precise massage therapy. This tech-driven approach could offer a more standardized experience and potentially improve accessibility to high-quality massage therapy for lower back pain sufferers.

What evidence suggests that the EMMA massage therapy is effective for lower back pain?

This trial will compare two approaches to massage therapy for lower back pain: indirect person massage therapy using the EMMA massage robot and direct person massage therapy by a licensed therapist. Studies have shown that users of the EMMA massage robot reported high satisfaction, finding it comfortable and helpful. EMMA employs advanced technology to deliver massages by understanding and adjusting to muscles, potentially easing lower back pain by targeting the right spots. Although specific pain relief results from this trial are not yet available, the robot's accuracy and positive feedback make it a promising option for those with lower back pain. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael Mueller

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with lower back pain who can fully participate and agree to use birth control if applicable. It's not for those recently in other drug trials, unable to lie prone, pregnant/breastfeeding, with unstable medical conditions or recent surgery, skin issues at massage site, implanted devices in the area, bleeding disorders or major cardiovascular events.

Inclusion Criteria

I am 18 years old or older.

I can report how much pain I am in right now.

My main pain is in my lower back.

Exclusion Criteria

Have used an investigational drug within 30 days of study enrollment

I cannot lay on my stomach.

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either direct massage therapy from a licensed therapist or indirect massage therapy through the EMMA robotic system, each session lasting approximately 20 minutes

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EMMA

Trial Overview The study compares patient experiences between two types of massage treatments for lower back pain: one given by a human therapist and another by a robotic system called EMMA (Expert Manipulative Massage Automation).

How Is the Trial Designed?

Group I: Indirect person massage therapy Experimental Treatment 1 Intervention

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 II: Direct person massage therapy Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10498686/

Satisfaction and Feasibility Evaluation of an Electronic ... This study suggests that the EMMA massager has high acceptability and satisfaction among healthy volunteers, thus demonstrating its feasibility.

2. withpower.com withpower.com/trial/phase-low-back-pain-7-2025-f8f8b

EMMA Massage Therapy for Lower Back Pain The purpose of this study is to gather information about patient experience receiving a massage through a robotic EMMA (Expert Manipulative Massage ...

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/lumbar-pain

Lumbar Pain Clinical Trials The purpose of this study is to gathering information about a patient's experience receiving a massage through a robotic EMMA (Expert Manipulative Massage ...

4. medica-tradefair.com medica-tradefair.com/en/media-news/spheres-of-medica-magazine/medtech-devices/ai-powered-massage-robot-evaluation-us-clinical-trial-singapore

Massage robot: evaluation in US, clinical trial in Singapore Singapore robotics firm AiTreat will be embarking on a new product evaluation in the United States for their massage robot powered by AI.

5. ieeexplore.ieee.org ieeexplore.ieee.org/iel8/6287639/10820123/10918642.pdf

Robotic Integration of Massage and Real-Time Tissue ... These systems leverage advanced robotics to automate the process of detecting and analyzing soft tissue properties, eliminating measurement.