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Could a daily ultrasound zap arthritis pain at home?

NCT ID NCT07163221

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tests a non-invasive device that uses ultrasound to stimulate the spleen and reduce inflammation in people with moderate to severe rheumatoid arthritis. About 60 adults who haven't responded well to standard medications will use the device at home for 12 weeks, with some receiving a sham treatment for comparison. The goal is to see if this approach can safely lower disease activity without the need for lifelong drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females ages 18 and above 2. Active moderate to severe seropositive RA 3. At least 6 total tender and/or swollen joints counted on a 28 joint assessment during screening and at Week 0 (a joint that is both tender and swollen will be counted as "2") 4. Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs 5. Receiving stable background treatment with a csDMARD prior to start of the treatment period at Week 0. Methotrexate (if chosen as background treatment) must be maintained at a stable dose for at least 4 weeks prior to Week 0, while all other csDMARDs (if chosen as background treatment) must be maintained at a stable dose for at least 8 weeks prior to Week 0. Participants must be willing to maintain their background medication regimen throughout the 28-week study period. 6. For participants that have previously undergone treatment with bDMARDs or tsDMARDs therapy, those treatments must be discontinued at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit 7. For participants that have previously undergone treatment with Golimumab or Infliximab, those treatments must be discontinued at least 8 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit 8. Participants may receive up to 10 mg of daily prednisone as part of their background treatment but must have maintained a stable dose for a minimum of 6 weeks prior to start of the treatment period at Week 0, and must be willing to maintain the stable dose until after the Week 24 Closeout Visit 9. Torso circumference at the belly button and sternum level must both be in the range of 25 to 50 inches 10. Participants with an immunomodulation device must be willing and able to turn the device off at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit 11. Participants must be willing not to initiate any new treatments with expected immune modulating effects during the study period, and any existing immune modulating treatments must be stabilized by Week 0 12. Participants must be willing and able to follow the medication rules described in the study's IRB-approved Medication Guide Exclusion Criteria: 1. Active bacterial or viral infection 2. Pregnant women or those trying to become pregnant 3. Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment 4. Having received more than a total of three bDMARDs and tsDMARDs 5. Having received Rituximab monoclonal antibody medication 6. Presence of an implanted device or other solid object in the vicinity of the spleen that can interfere with or absorb the ultrasound beam 7. History of asplenia 8. History of splenomegaly 9. History of ascites 10. Recent abdominal surgery 11. Currently participating in an investigational drug or device study 12. Open wound/sores that would make performing study procedures too difficult 13. Inability to perform minimal daily self-cares associated with feeding or dressing, such as lifting a cup of water to the mouth or putting on clothing. 14. Refusal or inability to regularly attend the scheduled on-site visits and at-home visits, or perform the remote video observation sessions 15. Cannot speak English 16. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Arizona Arthritis and Rheumatology Associates P.C.

    Glendale, Arizona, 85306, United States

  • Medvin Clinical Research

    Covina, California, 91722, United States

  • Southland Arthritis & Osteoporosis Medical Center

    Temecula, California, 92592, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases

    Minneapolis, Minnesota, 55455, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.