Clinical trial NCT03690466: Ultrasound Treatment of Rheumatoid Arthritis
Official title: Ultrasound Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group.
timeFrame: Day 0 (baseline) to Day 14 (end of treatment)
Secondary outcomes:
measure: Between-arm change in the DAS-28 from baseline to end of treatment.
timeFrame: Day 0 (baseline) to Day 14 (end of treatment)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Erik Peterson, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: