Could a daily ultrasound zap arthritis pain at home?
NCT ID NCT07163221
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Arizona Arthritis and Rheumatology Associates P.C.
Glendale, Arizona, 85306, United States
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Medvin Clinical Research
Covina, California, 91722, United States
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Southland Arthritis & Osteoporosis Medical Center
Temecula, California, 92592, United States
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University of Colorado
Aurora, Colorado, 80045, United States
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University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases
Minneapolis, Minnesota, 55455, United States
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Other studies related to the condition(s) this trial covers.
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