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Ultrasound Treatment of Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Study device treatment
Sham device treatment
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study device treatment

Sham device treatment

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Between-arm change in the DAS-28 from baseline to 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.

Full Information

First Posted
September 20, 2018
Last Updated
June 8, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03690466
Brief Title
Ultrasound Treatment of Rheumatoid Arthritis
Official Title
Ultrasound Treatment of Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study device treatment
Arm Type
Experimental
Arm 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.
Arm Title
Sham device treatment
Arm Type
Sham Comparator
Arm Description
Sham treatment will be administered to the spleen for 30 minutes every day for 2 weeks (14 days total) via a portable device.
Intervention Type
Device
Intervention Name(s)
Study device treatment
Other Intervention Name(s)
Treatment group
Intervention Description
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
Intervention Type
Device
Intervention Name(s)
Sham device treatment
Other Intervention Name(s)
Control group
Intervention Description
A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.
Primary Outcome Measure Information:
Title
Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group.
Description
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.
Time Frame
Day 0 (baseline) to Day 14 (end of treatment)
Secondary Outcome Measure Information:
Title
Between-arm change in the DAS-28 from baseline to end of treatment.
Description
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.
Time Frame
Day 0 (baseline) to Day 14 (end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Peterson, MD PHD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Ultrasound Treatment of Rheumatoid Arthritis

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