Acoustic Therapy for Knee Osteoarthritis

This trial aims to determine if a special ultrasound treatment, known as Sustained Acoustic Medicine, can ease pain and improve movement in people with knee osteoarthritis. Participants will use a device that delivers sound waves to the knee for several hours daily. The trial includes different groups; some will use the ultrasound device alone, while others will use it with a patch containing the common pain reliever diclofenac. Eligible participants should have doctor-confirmed knee osteoarthritis that affects their quality of life and must be willing to avoid certain other treatments during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you do not use or start any opioid or non-opioid pain medications during the study. You also need to stop any other knee treatments like electrical stimulation or traditional ultrasound.

Research shows that Sustained Acoustic Medicine (SAM) is generally easy for people to use. Studies indicate that SAM uses gentle ultrasound waves to create deep warmth in body tissues, relieving pain and improving joint function. The FDA has cleared this type of ultrasound device, confirming its safety for use.

When combined with a diclofenac patch—a patch that reduces pain and swelling—SAM has shown good results in enhancing patient comfort. Diclofenac, a well-known pain relief medication, further supports its safety.

Researchers are excited about these treatments because they utilize sustained acoustic medicine, which offers a novel approach for managing knee osteoarthritis. Unlike standard treatments like NSAIDs, corticosteroid injections, or physical therapy, the SAM Ultrasonic Diathermy Device delivers continuous ultrasound waves at a frequency of 3 MHz, providing targeted therapy without drugs. This method could potentially reduce inflammation and pain by enhancing cellular repair and blood flow, offering an alternative for those seeking non-invasive options. Additionally, the combination with diclofenac patches presents a dual approach that could enhance pain relief while minimizing systemic drug exposure.

In this trial, participants will receive different treatments to evaluate their effectiveness in reducing knee osteoarthritis pain. Research has shown that using Sustained Acoustic Medicine (SAM) with a diclofenac patch can help reduce this type of pain. One study found that this combination provided better pain relief and improved joint function compared to standard care. SAM uses sound waves to gently heat tissues, aiding in healing and pain reduction. Another study found that using SAM with diclofenac is safe and effective for reducing pain and improving movement. Overall, these treatments show promise in helping people with knee osteoarthritis feel better and move more easily.¹²⁴⁶⁷