Ultrasound Treatment of Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Device: Study device treatment; Device: Sham device treatment

• Registration Number: NCT03690466
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2018-10-03
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study device treatment	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.
Sham device treatment	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.

Primary Outcome Measures

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

Name	Time	Method
Between-arm change in the DAS-28 from baseline to end of treatment.	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States