Ultrasound Therapy for Rheumatoid Arthritis
(SUSTAIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether daily at-home ultrasound therapy can help people with rheumatoid arthritis (RA) by calming their immune system. Researchers aim to determine if this treatment is safe and effective enough for larger future studies. Participants are divided into two groups: one receives real ultrasound therapy, while the other receives a placebo treatment that feels the same but has no effect. The trial seeks individuals with RA who have at least moderate symptoms, such as swollen and tender joints, and who are on stable medication for their condition. Participants must use the device at home daily and attend regular check-ups. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
You may need to stay on a stable dose of your current medications, especially DMARDs (disease-modifying antirheumatic drugs), as the trial requires participants to maintain a stable dose during the study. If your medication dose was recently changed, you might not be eligible to participate.
What prior data suggests that this ultrasound therapy is safe for rheumatoid arthritis patients?
Research has shown that ultrasound therapy is generally safe for people with rheumatoid arthritis (RA). In one study, researchers monitored patients for up to two years, and those who received ultrasound treatment experienced no major safety problems. The treatment was manageable, with only a few minor side effects reported.
While ultrasound often checks joint inflammation in RA, its use as a treatment remains under study. As this trial is in an early stage, researchers are still gathering safety information. However, previous studies have not identified significant safety issues, suggesting that the therapy is likely safe for most participants.12345Why are researchers excited about this trial?
Researchers are excited about ultrasound therapy for rheumatoid arthritis because it offers a non-invasive approach to managing the condition. Unlike standard treatments like DMARDs (Disease-Modifying Anti-Rheumatic Drugs) and biologics, which involve medications that alter the immune response, ultrasound therapy uses sound waves to potentially reduce inflammation and pain. This method could provide a safer option with fewer side effects, offering patients a new way to manage symptoms from the comfort of their homes.
What evidence suggests that ultrasound therapy is effective for rheumatoid arthritis?
Research has shown that ultrasound therapy can reduce symptoms of rheumatoid arthritis (RA) in the short term. For instance, one study found that using ultrasound therapy in water reduced pain more than a fake treatment after two weeks. However, these benefits did not last, as there was no significant improvement after 14 weeks. Another study found that ultrasound did not improve long-term results when used as a treatment goal. In this trial, participants will receive either daily active ultrasound stimulation or a sham treatment that mimics the experience without delivering ultrasound energy. While ultrasound therapy seems helpful in the short term, its long-term effectiveness for RA remains uncertain.16789
Are You a Good Fit for This Trial?
This trial is for adults with Rheumatoid Arthritis (RA) who have at least moderate disease activity. It's designed to see if using ultrasound stimulation at home can help manage RA by changing how the immune system and nerves interact.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1: Open-label Pilot Study
5-8 participants receive active daily ultrasound stimulation to assess feasibility and safety
Stage 2: Randomized Double-blind Study
Up to 30 participants receive either active or sham daily ultrasound stimulation to estimate treatment effect size
Follow-up
Participants are monitored for safety and durability of clinical and immunologic effects post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Active treatment
- Sham (No Treatment)
Trial Overview
The study tests an active treatment involving ultrasound stimulation against a sham (no real treatment). Participants will use the therapy daily at home, and researchers aim to learn if it's feasible, safe, and effective before planning a larger trial.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Daily active stimulation for 8 weeks
Daily sham stimulation, for 8 weeks, which will look and feel the same as active stimulation, but with no ultrasound energy entering the body
Find a Clinic Near You
Who Is Running the Clinical Trial?
Surf Therapeutics
Lead Sponsor
Citations
Clinical and ultrasound remission at 48 weeks of ...
Conclusions: After 12 months of UPA treatment, a substantial proportion of RA patients achieved combined clinical and US remission, independent ...
2.
the-rheumatologist.org
the-rheumatologist.org/article/ultrasound-as-ra-treat-to-target-strategy-doesnt-improve-long-term-outcomes/Ultrasound as RA Treat-to-Target Strategy Doesn't Improve ...
Using ultrasound remission as a target was not associated with better long-term outcomes for RA patients.
POS0474 ULTRASOUND REMISSION RATES AFTER 1 ...
The randomized controlled NORD-STAR trial demonstrated remission rates of 40-60% in patients with early rheumatoid arthritis (RA) at 24 and 48 weeks.
Effects of underwater ultrasound therapy on pain ...
Underwater ultrasound therapy was better than sham treatment at the end of 2 weeks of treatment, but not at long term (14 weeks) in patients with rheumatoid ...
Ultrasound in management of rheumatoid arthritis
Joint inflammation visualised by ultrasound is present in a majority of rheumatoid arthritis patients in clinical remission, and several studies ...
Ultrasound Impact in Rheumatoid Arthritis Patient Reported ...
Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients classified in remission/low disease activity in terms of Patient ...
The role of musculoskeletal ultrasound in difficult-to-treat RA
Musculoskeletal ultrasound (MSK-US) provides information on MSK inflammatory load and damage, being widely used in RA and inflammatory arthritides.
8.
reumatologiaclinica.org
reumatologiaclinica.org/en-clinical-patient-reported-ultrasound-outcomes-from-articulo-S2173574319301716Clinical, Patient-Reported, and Ultrasound Outcomes from ...
Spanish patients with RA demonstrated improvements in clinical, PDUS and patient-reported outcomes over 12 weeks of CZP treatment. No new safety signals were ...
Diagnostic performance and reliability of robotic ...
Conclusion A moderate to good overall agreement was seen between RUS and HUS in assessing synovitis in RA hands. However, at the joint level, ...
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