Ultrasound Treatment of Rheumatoid Arthritis
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 3/8/2019 |
| Start Date: | September 28, 2018 |
| End Date: | May 17, 2020 |
| Contact: | Julie Scherber |
| Email: | sche0245@umn.edu |
| Phone: | 612-626-7734 |
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.
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.
Inclusion Criteria:
1. Males and Females aged 18-85.
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.
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Erik Peterson, MD PHD
Phone: 612-626-7734
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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