Sustained Acoustic Medicine for Osteoarthritis

Overseen By George K. Lewis, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ZetrOZ, Inc.

Must not be taking: Opioids, Non-opioid analgesics

Disqualifiers: Pregnancy, Pacemaker, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment option for osteoarthritis, often called degenerative joint disease. The study compares a device using sound waves (ultrasound) combined with a pain relief patch (Sustained Acoustic Device with 2.5% Diclofenac Patch) to a standard topical gel. It aims to determine if this combination can better manage pain and improve joint function. Individuals with mild to moderate osteoarthritis in areas like the knee or shoulder, who experience daily discomfort, may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

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 treatments on the affected area, like electrical nerve stimulation or ultrasound.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that over 95% of patients using the Sustained Acoustic Medicine (SAM) device with a 2.5% diclofenac patch considered it safe, effective, and easy to use. Most participants handled the treatment well, with no major safety concerns reported. This combination of sound wave therapy and pain relief gel could offer a promising option for managing osteoarthritis symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard osteoarthritis treatments, which often include oral painkillers like NSAIDs or corticosteroid injections, this new approach combines a sustained acoustic medicine (SAM) device with a 2.5% diclofenac patch. The SAM device is unique because it uses continuous ultrasound at a 3 MHz frequency to enhance drug delivery and potentially reduce inflammation more effectively. Researchers are excited about this treatment as it offers a non-invasive, targeted delivery system that could minimize systemic side effects and provide more consistent pain relief. This innovative combination could offer a more effective and safer alternative for managing osteoarthritis symptoms.

What evidence suggests that the Sustained Acoustic Device with 2.5% Diclofenac Patch could be effective for osteoarthritis?

Research has shown that using the Sustained Acoustic Medicine (SAM) device with a 2.5% diclofenac patch, which participants in this trial will receive, might help relieve osteoarthritis symptoms. In one study, more than 95% of patients found this treatment safe, effective, and easy to use for managing knee osteoarthritis. Another study found that the SAM device increased blood flow by about 19%, which can help reduce pain and swelling. These results suggest that SAM with diclofenac could improve pain and movement in people with osteoarthritis. ^{1 2 3 5 6}

Who Is on the Research Team?

Sandra Winkler, Ph.D.

Principal Investigator

James A. Haley Veterans Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 35-80 with mild to moderate knee osteoarthritis, experiencing pain levels of 3-7. Participants must not use other pain medications or topical treatments during the study and should be able to self-administer daily treatment.

Inclusion Criteria

Are deemed appropriate by their physician or by the study site physician to participate.

My doctor says I have mild to moderate knee arthritis.

I am between 35 and 80 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 1% Diclofenac Topical Gel
• Placebo Sustained Acoustic Device with 0% Diclofenac Patch
• Sustained Acoustic Device with 2.5% Diclofenac Patch

Trial Overview The study compares Sustained Acoustic Medicine combined with a 2.5% Diclofenac Patch against just the patch alone for managing osteoarthritis symptoms, measuring changes in pain and joint function.

How Is the Trial Designed?

Group I: SAM Ultrasound Device and Diclofenac Patch Experimental Treatment 2 Interventions

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Who Is Running the Clinical Trial?

ZetrOZ, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+

Published Research Related to This Trial

Sustained Acoustic Medicine (SAM) is a non-invasive treatment that has shown effectiveness in reducing pain and improving function in patients with musculoskeletal injuries, based on a review of 13 clinical studies involving 372 participants.

SAM can be a beneficial adjunct therapy for patients who do not respond to traditional physical therapy, offering a safe and effective option for promoting tissue recovery and facilitating a return to work.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis. Winkler, SL., Urbisci, AE., Best, TM.[2021]

The study developed a drug release platform using diclofenac-loaded alginate microcapsules that showed improved anti-inflammatory effects when activated by ultrasound, achieving an 81% inhibition rate in a rat model, significantly higher than the 60% inhibition rate from diclofenac alone.

Continuous and pulsatile ultrasound irradiation enhanced drug release rates by approximately 30% and 16%, respectively, indicating that ultrasound can be effectively used to control drug delivery and improve therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effect with high intensity focused ultrasound-mediated pulsatile delivery of diclofenac. Wang, CY., Yang, CH., Lin, YS., et al.[2018]

Therapeutic ultrasound is a well-established method used by physical therapists to enhance tissue healing and circulation, but traditional equipment has limited accessibility and effectiveness.

The development of portable, wearable ultrasound devices allows for self-application and long-duration treatments, which may improve outcomes for various musculoskeletal conditions by optimizing the timescale of acoustic stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Acoustic Medicine: A Novel Long Duration Approach to Biomodulation Utilizing Low Intensity Therapeutic Ultrasound. Langer, MD., Lewis, GK.[2023]

Adding 2.5% diclofenac sodium to ultrasound coupling gel significantly enhances the gel's density and acoustic properties, improving the delivery of therapeutic ultrasound to deeper tissues without affecting the heating profile.

The combination of diclofenac with ultrasound therapy allows for longer sustained deep tissue heating, which can enhance the healing process for soft tissue injuries while maintaining safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Diathermy Performance Evaluation of Multi-hour Sustained Acoustic Medicine Treatment with 2.5% Diclofenac Ultrasound Coupling Patch. Hendren, TF., Yeretzian, NR., Bavanasi, K.[2023]

In a study of 32 patients with knee osteoarthritis, the combination of Sustained Acoustic Medicine (SAM) ultrasound therapy and a 1% diclofenac gel significantly reduced pain by an average of 2.06 points (50%) on a pain scale over one week, with 75% of patients showing rapid improvement after the first treatment.

The treatment also led to a significant improvement in function, as measured by the WOMAC score, with over 95% of participants reporting the device as safe, effective, and easy to use, indicating its potential as a non-invasive option for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Madzia, A., Agrawal, C., Jarit, P., et al.[2022]

In a study of 60 patients with knee osteoarthritis, both ibuprofen phonophoresis (PH) and conventional ultrasound (US) therapy showed similar effectiveness in improving pain and function, with no significant differences in outcomes after 10 treatment sessions.

Both treatment methods were well tolerated, and satisfaction rates were high among both patients and investigators, indicating that while ibuprofen PH is effective, it does not provide additional benefits over conventional ultrasound therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short term efficacy of ibuprofen phonophoresis versus continuous ultrasound therapy in knee osteoarthritis. Kozanoglu, E., Basaran, S., Guzel, R., et al.[2022]

In a study of 46 patients with mild to moderate knee osteoarthritis, phonophoresis of piroxicam (PhP) significantly reduced pain more than ultrasound therapy (UT), as measured by the visual analog scale (VAS).

Both treatment methods improved knee function, but PhP showed a trend towards better outcomes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, suggesting it may be a more effective option for managing symptoms of knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of phonophoresis of piroxicam and ultrasound on symptomatic knee osteoarthritis. Luksurapan, W., Boonhong, J.[2013]

The study demonstrated that using a wearable sonophoresis device significantly enhances the delivery of diclofenac gel through the skin, increasing drug delivery by 3.8 times and penetration by 32% compared to standard topical application.

This method of transdermal drug delivery could improve the efficacy of NSAIDs like diclofenac in managing arthritis pain, offering a promising alternative to traditional topical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained acoustic medicine; sonophoresis for nonsteroidal anti-inflammatory drug delivery in arthritis. Masterson, J., Kluge, B., Burdette, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05882812

Sustained Acoustic Medicine (SAM) for Symptomatic ... This is an 8-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7784557/

Sustained Acoustic Medicine Combined with A Diclofenac ... Over 95% of patients found the device safe, effective and easy to use, and would continue treatment for their knee OA symptoms. Conclusion:.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06257537

Sustained Acoustic Medicine for Symptomatic Treatment of ... This is a 24-week study to clinically evaluate the effectiveness of the wireless Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33408796/

Sustained Acoustic Medicine Combined with A Diclofenac ... Over 95% of patients found the device safe, effective and easy to use, and would continue treatment for their knee OA symptoms. Conclusion: ...

5. frontiersin.org frontiersin.org/journals/medical-technology/articles/10.3389/fmedt.2025.1552294/full

Sustained acoustic medicine increases local circulation ... Results: SAM increased blood flow significantly over 60 min by 19.2 PU (p < 0.0001) with coupling patch and 18.6 PU with 2.5% diclofenac patch (p < 0.0001) vs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10485907/

Clinical Diathermy Performance Evaluation of Multi-hour ... This study aims to determine the ultrasound coupling and diathermic effects of adding 2.5% diclofenac sodium to the ultrasound coupling patch in the SAM ...