Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound Treatment of Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE September 28, 2018
Estimated Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03690466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Treatment of Rheumatoid Arthritis
Official Title  ICMJE Ultrasound Treatment of Rheumatoid Arthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Study device treatment
  • 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.
    Intervention: Device: Sham device treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 17, 2020
Estimated Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Scherber 612-626-7734 sche0245@umn.edu
Contact: Hubert Lim, PHD hlim@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03690466
Other Study ID Numbers  ICMJE Study00003642
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erik Peterson, MD PHD University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP