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Ultrasound Treatment of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03690466
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

The research objective is to demonstrate 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 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: Study device treatment Device: Sham device treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Treatment of Rheumatoid Arthritis
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : March 17, 2020
Estimated Study Completion Date : May 17, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Control group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and Females aged 18-85.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690466


Contacts
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Contact: Julie Scherber 612-626-7734 sche0245@umn.edu
Contact: Hubert Lim, PHD hlim@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Julie Scherber    612-626-7734    sche0245@umn.edu   
Principal Investigator: Erik Peterson, MD PHD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Erik Peterson, MD PHD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03690466     History of Changes
Other Study ID Numbers: Study00003642
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases