Ultrasound Treatment of Rheumatoid Arthritis

June 8, 2022 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study device treatment
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
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
Other Names:
  • Treatment group
Sham Comparator: Sham device treatment
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
A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (baseline) to Day 14 (end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-arm change in the DAS-28 from baseline to end of treatment.
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.
Day 0 (baseline) to Day 14 (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Erik Peterson, MD PHD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

April 28, 2022

Study Completion (Actual)

April 28, 2022

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHEUM-2018-26732

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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