An interventional study of Study device treatment and Sham device treatment in Rheumatoid Arthritis, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-13.
Sponsored by University of Minnesota · Not applicable, Interventional, and Device feasibility
The research objective of the pilot study is to assess early feasibility of safety and efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a blinded and randomized controlled trial. Specific Aims include:
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 19 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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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).
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).
Exclusion Criteria:
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.
Device: Study 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.
Device: Sham device treatment
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
Also known as: Treatment group
A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.
Also known as: Control group
Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group.
Full p-value of 0.05 will be allocated to Primary Outcome Measure and then if outcome is satisfied, the full p-value of 0.05 will be allocated to Secondary Outcome Measure.
Time frame: Day 0 (baseline) to Day 14 (end of treatment)
Between-arm change in the DAS-28 from baseline to end of treatment.
Full p-value of 0.05 will be allocated to Primary Outcome Measure and then if outcome is satisfied, the full p-value of 0.05 will be allocated to Secondary Outcome Measure.
Time frame: Day 0 (baseline) to Day 14 (end of treatment)
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Minnesota