Ultrasound Treatment of Rheumatoid Arthritis

University of Minnesota (UMN)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Device: Sham device treatment; Device: Study device treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03690466

RHEUM-2018-26732

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

19 participants in 2 patient groups

Study device treatment

Experimental group

Description:

Transcutaneous non-invasive ultrasound will be administered to the spleen for 30 minutes every day for 2 weeks (14 days total) via a portable device.

Treatment:

Device: Study device treatment

Sham device treatment

Sham Comparator group

Description:

Sham treatment will be administered to the spleen for 30 minutes every day for 2 weeks (14 days total) via a portable device.

Treatment:

Device: Sham device treatment