Lower Back PainNCT07040397
Electronic Approach to the Human Massage Therapist
A study testing EMMA massage therapy and Clinical massage treatment in people with Lower Back Pain, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- EMMA massage therapy and Clinical massage treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Pearl Buabeng, 507-266-1213, GIMResearchStudies@Mayo.edu
Michael Mueller
About this study
Official title: Comparing an Electronic Approach to the Human Massage Therapist.
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.
Read the detailed description
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
- Lower Back Pain
- Being tested
- EMMA massage therapy, Clinical massage treatment
- Keywords
- massage, Low Back Pain, automated massage, EMMA (expert manipulative massage automation), electric massager
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMMA massage therapyDevice
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Indirect person massage therapy | Experimental | 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. Receives: Device: EMMA massage therapy |
| Direct person massage therapy | Active comparator | Clinical massage treatment procedures are delivered by a clinically licensed massage therapist. This treatment will last approximately 20 minutes. Receives: Other: Clinical massage treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to end of study (year 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start30 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 will be randomized to EMMA and 20 to a certified massage therapist. Everyone will receive a massage treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael R. Mueller, Mayo Clinic
- Investigators
- Michael Mueller, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040397
- Sponsor's protocol ID
- 25-002863
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing an Electronic Approach to the Human Massage Therapist.
- ClinicalTrials.gov ID
- NCT07040397
- Acronym / sponsor ID
- 25-002863
- Conditions
- Lower Back Pain
- Keywords
- massage, Low Back Pain, automated massage, EMMA (expert manipulative massage automation), electric massager
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 will be randomized to EMMA and 20 to a certified massage therapist. Everyone will receive a massage treatment.
| Arm | Type | Receives |
|---|---|---|
| Indirect person massage therapy | Experimental | Device: EMMA massage therapyA 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. |
| Direct person massage therapy | Active comparator | Other: Clinical massage treatmentClinical massage treatment procedures are delivered by a clinically licensed massage therapist. This treatment will last approximately 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMMA massage therapyExpert 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. | Device | Indirect person massage therapy |
| Clinical massage treatmentThe 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. | Other | Direct person massage therapy |
Primary outcome
Number of patients enrolled
Time frame: baseline to end of study (year 2)
Feasibility will be determined by the total number of patients screened in order to accrue the 40 needed to complete the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Mueller principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMMA massage therapy and Clinical massage treatment in people with Lower Back Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled (time frame: baseline to end of study (year 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.