Could a daily ultrasound zap rheumatoid arthritis pain?

NCT ID NCT07293871

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether a daily, at-home ultrasound device can safely reduce inflammation and joint pain in people with rheumatoid arthritis. About 40 adults with moderate-to-severe RA will use either an active or a sham device for 8 weeks. The study focuses on safety and whether the device is practical for daily use, with the goal of designing a larger future trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ultrasound stimulation device
What this could lead to
If this works, it could point toward a non-drug, at-home treatment to help control rheumatoid arthritis symptoms and inflammation.
What could go wrong
This is a small, early-phase trial with only 40 people. It is designed mainly to test safety and feasibility, so it may not show clear benefit. The effect, if any, might be small or not last.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * At least 18 years old * Diagnosis of rheumatoid arthritis as defined by ACR/EULAR 2010 classification criteria * At least moderate disease activity, defined as ≥4 tender joints (28-joint count) and ≥4 swollen joints (28-joint count) and a DAS28-CRP \>3.2 at the baseline visit * hsCRP \> 0.3 mg/dL at the last qualifying visit, baseline or retest * If on background DMARD therapy, must be on stable dose (see exclusion criteria) * Able and willing to comply with all study-related procedures, including daily treatment sessions in the study vehicle, research site visits, and assessments Exclusion Criteria: * Unable to provide informed consent * Current or planned participation in another interventional clinical trial * Inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis. Current diagnosis of secondary Sjogren's Syndrome is permitted. * Prior use of \>2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was efficacy * Conventional synthetic DMARDs: * Initiation within 12 weeks prior to enrollment * Dose adjustment or discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * Biologic DMARDs: * Initiation or dose adjustment within 12 weeks prior to enrollment * Discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * JAK inhibitors: * Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * Corticosteroids: * Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment * Current dose \>10 mg/day prednisone (or equivalent) * If on a stable dose, inability to maintain the stable dose during the study * NSAIDs: * Initiation, dose adjustment, or discontinuation of high-dose NSAIDs (≥1200 mg/day ibuprofen) within 14 days of informed consent. Over-the-counter use of NSAIDs is permissible. * Pregnant or planning to become pregnant during the study period * Known hypersensitivity to ultrasound gel or membrane components * History of splenic disorders, including splenectomy, congenital asplenia, or splenomegaly on baseline visit ultrasound * Rash, wound, or skin infection overlying the spleen * History of vagal nerve injury, vagotomy, or known autonomic neuropathy * Recent abdominal surgery or trauma within 30 days of screening * Skin to spleen hilum depth \>7 cm as measured by ultrasound at the baseline visit * Abdominal anatomy or condition precluding adequate ultrasound targeting of the spleen * Uncontrolled fibromyalgia or other diffuse pain syndromes that may confound symptom reporting * Any condition that, in the investigator's judgment, would preclude safe participation or compliance with study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Precision Comprehensive Clinical Research Solutions

    RECRUITING

    Colleyville, Texas, 75034, United States

    Contact Email: •••••@•••••

  • Precision Comprehensive Clinical Research Solutions

    RECRUITING

    Irving, Texas, 75061, United States

    Contact Email: •••••@•••••

  • Rheumatology Associates

    RECRUITING

    Dallas, Texas, 75231, United States

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