Ultrasound Treatment of Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT03690466|
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : March 6, 2019
The research objective is to demonstrate safety and efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a blinded and randomized controlled trial. Specific Aims include:
- Measure RA disease activity and functional 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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Device: Study device treatment Device: Sham device treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
This will be a controlled, randomized, double-blinded trial of short-term (14 days) treatment with ultrasound stimulation (therapeutic energy dose) or sham (no energy dose) delivered to the spleen.
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.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ultrasound Treatment of Rheumatoid Arthritis|
|Actual Study Start Date :||September 28, 2018|
|Estimated Primary Completion Date :||March 17, 2020|
|Estimated Study Completion Date :||May 17, 2020|
Experimental: 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.
Device: Study device treatment
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
Other Name: Treatment group
Sham Comparator: 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.
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.
Other Name: Control group
- Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group. [ Time Frame: Day 0 (baseline) to Day 14 (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.
- Between-arm change in the DAS-28 from baseline to end of treatment. [ Time Frame: Day 0 (baseline) to Day 14 (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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690466
|Contact: Julie Scherberfirstname.lastname@example.org|
|Contact: Hubert Lim, PHDemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Julie Scherber 612-626-7734 firstname.lastname@example.org|
|Principal Investigator: Erik Peterson, MD PHD|
|Principal Investigator:||Erik Peterson, MD PHD||University of Minnesota - Clinical and Translational Science Institute|