Ultrasound for Osteoarthritis

This trial tests a new ultrasound treatment, specifically Long Duration High Frequency Ultrasound, to determine its effectiveness in easing knee pain from osteoarthritis and improving joint function over 12 weeks. Participants will receive either ultrasound treatment with a medicated patch, a non-medicated patch, or a corticosteroid injection. The trial seeks individuals diagnosed with mild to moderate knee osteoarthritis who experience frequent pain affecting daily life. Those who find knee pain problematic and can commit to daily treatment may find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in osteoarthritis care.

You cannot use or start using opioid or non-opioid pain medications during the study. You also need to stop any other treatments on your knee, like electrical stimulation or traditional ultrasound.

Research has shown that the SAM Ultrasound Device used in this trial is generally well-tolerated. In earlier studies, patients using the SAM device with a diclofenac patch reported no significant side effects. The device uses ultrasound energy to reduce pain and improve joint function. The FDA has approved it for home use, indicating trust in its safety for pain relief.

When combined with the diclofenac patch, the SAM device has not raised major safety concerns. Studies suggest it is easy to use and does not cause serious side effects, making it a potentially safe option for individuals with knee osteoarthritis seeking pain relief.

The trial also includes a corticosteroid injection (triamcinolone acetonide) for comparison. These injections are commonly used and generally considered safe for short-term pain relief in osteoarthritis patients, though they can sometimes cause side effects like joint infection or increased pain.

Researchers are excited about the use of high-frequency ultrasound for osteoarthritis because it offers a non-invasive approach to pain relief and joint function improvement. Unlike standard treatments such as oral medications or injections, the SAM Ultrasonic Diathermy Device emits continuous ultrasound waves that can penetrate deeper into tissues, potentially enhancing healing and reducing inflammation without systemic side effects. Additionally, the combination of ultrasound with a diclofenac patch provides targeted anti-inflammatory benefits right at the source of pain, which is a novel delivery method that could improve patient outcomes compared to traditional treatments.

Research has shown that using the SAM Ultrasound Device with a diclofenac patch, one of the treatment options in this trial, may help reduce knee osteoarthritis pain. Earlier studies found this combination effective in easing arthritis pain and improving joint function. The device delivers continuous ultrasound waves for extended periods, which can lessen pain and aid healing. Some studies also suggest it can reduce the need for pain medications. Multiple research findings support this method, showing promise for people with knee osteoarthritis. Another arm of this trial will test the SAM Ultrasound Device with a SAM patch containing no diclofenac, while a separate arm will evaluate the effects of a single corticosteroid injection.¹³⁶⁷⁸