Ultrasound Treatment of Rheumatoid Arthritis

University of Minnesota1 site in 1 country19 target enrollmentOctober 3, 2018

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: University of Minnesota
Enrollment: 19
Locations: 1
Primary Endpoint: Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 3, 2018

End Date

April 28, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and Females aged 18 and over.
•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).
•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

•Active bacterial or viral infection.
•Pregnant women or presence of active malignancy.
•Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ.

Outcomes

Primary Outcomes

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.