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Completed

NCT Number: NCT03690466

Ultrasound Treatment of Rheumatoid Arthritis

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study device treatment

Device

The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.

Other names: Treatment group

Sham device treatment

Device

A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.

Other names: Control group

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2018
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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