Ultrasound Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Ultrasound Treatment of Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690466
• Other study ID #: RHEUM-2018-26732
• Status: Completed
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: April 28, 2022

Study information

• Verified date: June 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Study device treatment
The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 (baseline) to Day 14 (end of treatment)
Secondary	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.	Day 0 (baseline) to Day 14 (end of treatment)