Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study] (ULTRA)
Rheumatoid Arthritis
About this trial
This is an interventional device feasibility trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Males and females ages 18 and above
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 synovial thickening in at least 1 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 inflammatory disease control according to one of two measures:
- Multidimensional HAQ score of greater than 0.3
- DAS-28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease_Activity_Score_-_CRP_(DAS-CRP)
- Candidate participant's rheumatoid arthritis medical therapy should be stable for two weeks leading up to the study. Moreover, participants must be willing to maintain their current medication regimen throughout the study enrollment period (in adjunct to the additional investigational ultrasound treatment)
Exclusion Criteria:
- Active bacterial or viral infection
- Pregnant women or those trying to become pregnant
- Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
- Having received Rituximab monoclonal antibody medication within 30 days prior to enrollment
- Presence of an implanted device
- Asplenia
- Splenomegaly
- Ascites
- Recent abdominal surgery
- Currently participating in an investigational drug or device study
- Open wound/sores near stimulation sites
- Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ
- Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Sites / Locations
- University of Minnesota - Phillips-Wangensteen Building
- University of Minnesota Health Clinics and Surgery Center
Arms of the Study
Arm 1
Experimental
Ultrasound Group