Ultrasound Treatment of Rheumatoid Arthritis

NCT03690466 | Completed FDA Device

• 1 other identifier: RHEUM-2018-26732
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group.

  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.

  Day 0 (baseline) to Day 14 (end of treatment)

Secondary Outcomes (1)

• Between-arm change in the DAS-28 from baseline to end of treatment.

  Day 0 (baseline) to Day 14 (end of treatment)

Study Arms (2)

Study device treatment

EXPERIMENTAL

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.

Device: Study device treatment

Sham device treatment

SHAM COMPARATOR

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

Device: Sham device treatment

Interventions

Study device treatment DEVICE

The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.

Also known as: Treatment group

Study device treatment

Sham device treatment DEVICE

A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.

Also known as: Control group

Sham device treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Goggins E, Inoue H, Okusa MD. Neuroimmune Control of Inflammation in Acute Kidney Injury and Multiorgan Dysfunction. J Am Soc Nephrol. 2025 Dec 1;36(12):2473-2484. doi: 10.1681/ASN.0000000813. Epub 2025 Jul 7.

  PMID: 40622772 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Erik Peterson, MD PHD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 1, 2018
• Study Start: October 3, 2018
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

US (1)