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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COMPLETED
NA
19 participants
INTERVENTIONAL
2018-10-03
2022-04-28
Brief Summary
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* Measure RA disease activity and functional/biomarker metrics during and after a 2- week course of spleen-directed daily ultrasound treatments (within-arm and between-arm assessments); and
* Monitor adverse events during and after daily ultrasound treatments.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants will be provided a portable ultrasound device or sham device for at home use. Participants will be trained on how to use the device and will be instructed to use it for 30 minutes per day, at approximately the same time each day for 14 days.
Participants will be assessed at several time points before, during and at the end of treatment as well as a one-week follow-up visit.
DEVICE_FEASIBILITY
QUADRUPLE
Study Groups
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Study device treatment
Transcutaneous non-invasive ultrasound will be administered to the spleen for 30 minutes every day for 2 weeks (14 days total) via a portable device.
Study device treatment
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
Sham device treatment
Sham treatment will be administered to the spleen for 30 minutes every day for 2 weeks (14 days total) via a portable device.
Sham device treatment
A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.
Interventions
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Study device treatment
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
Sham device treatment
A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must carry a diagnosis of rheumatoid arthritis, as defined by the American College of Rheumatology in 2010: (https://www.rheumatology.org/Portals/0/Files/2010\_revised\_criteria\_classification\_ra.pdf).
Classification as "definite RA" is based on the confirmed presence of synovitis in at least one joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0-5), serologic abnormality (score range 0-3), elevated acute-phase response (score range 0-1), and symptom duration (2 levels; range 0-1).
3. Exhibiting symptoms or signs of inadequate disease control according to one of 2 measures:
Modified HAQ score of greater than 0.3 and DAS28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease\_Activity\_Score\_-\_CRP\_(DAS-CRP).
4. Participants should have home access to broadband internet, such that online video conversations can occur with study personnel via study-provided personal digital assistive devices.
Exclusion Criteria
2. Pregnant women or presence of active malignancy.
3. Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ.
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Erik Peterson, MD PHD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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Goggins E, Inoue H, Okusa MD. Neuroimmune Control of Inflammation in Acute Kidney Injury and Multiorgan Dysfunction. J Am Soc Nephrol. 2025 Jul 7. doi: 10.1681/ASN.0000000813. Online ahead of print.
Other Identifiers
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RHEUM-2018-26732
Identifier Type: -
Identifier Source: org_study_id
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