Rheumatoid Arthritis
Conditions
Brief summary
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: * 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.
Interventions
DEVICEStudy device treatment
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
DEVICESham 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and Females aged 18 and over. 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
1. Active bacterial or viral infection. 2. Pregnant women or presence of active malignancy. 3. Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between-arm change in the DAS-28 from baseline to end of treatment. | 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. |
Countries
United States
Outcome results
None listed