This clinical study will investigate the use of daily ultrasound for the treatment of rheumatoid arthritis (RA).
The main outcome of interest is an improvement in RA disease activity. The trial will take place in Minneapolis, Minnesota, United States.
The details
Rheumatoid arthritis (RA) is a long-term condition caused by inflammation. This leads to painful swelling and damage to tissue in the joints. RA is usually managed with medication to reduce inflammation. This can be difficult to manage long-term. Many RA drugs have side effects. The effectiveness of drugs may lessen over the course of the disease. The spleen is an important organ in the immune system. Studies suggest that stimulating the spleen using ultrasound can reduce inflammation.
This trial will investigate the use of daily spleen ultrasound stimulation for the treatment of RA. The main outcome to be measured is an improvement in RA disease activity.
Who are they looking for?
This study will recruit 20 patients with RA. Patients must have inadequate disease control. Participants must also have home access to broadband internet.
Participants with an active viral or bacterial infection cannot take part in the trial. Pregnant women, people with active malignancy (cancer), and those with reduced capacity for daily self-care (such as feeding and dressing) cannot take part in the study.
How will it work
Participants will be assigned to one of two groups. In the treatment group, patients will have a non-invasive ultrasound to the spleen for 30 minutes each day. This will be done using a portable device. Participants in the control groups will have a portable device that does not administer an ultrasound. The study will last 2 weeks.RA disease will be measured using the Disease Activity Score (DAS-28) at the beginning and end of the study.
The main outcome will be an improvement in RA disease activity.
