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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.

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.

What data supports the effectiveness of this treatment for osteoarthritis?

Research shows that using sustained acoustic medicine (a type of ultrasound therapy) with diclofenac gel can significantly increase the amount of the drug that penetrates the skin, making it more effective for pain relief in arthritis. A study found that this method increased diclofenac delivery by nearly four times compared to standard topical application, suggesting it could be a promising treatment for osteoarthritis. ^{1 2 3 4 5}

Is Sustained Acoustic Medicine safe for humans?

Sustained Acoustic Medicine, when used with diclofenac patches, has been shown to deliver the drug effectively without any reported unwanted side effects, suggesting it is generally safe for human use. ^{1 4 5 6 7}

How is the Sustained Acoustic Medicine treatment with a diclofenac patch different from other osteoarthritis treatments?

This treatment is unique because it combines a wearable ultrasound device with a diclofenac patch to enhance drug delivery through the skin, increasing the effectiveness of the medication compared to standard topical applications. The ultrasound device is portable and allows for long-duration, home-use therapy, which is not typical for traditional osteoarthritis treatments. ^{1 4 5 6 8}

Research Team

Sandra Winkler, Ph.D.

Principal Investigator

James A. Haley Veterans Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of phonophoresis of piroxicam and ultrasound on symptomatic knee osteoarthritis. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Short term efficacy of ibuprofen phonophoresis versus continuous ultrasound therapy in knee osteoarthritis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Sustained acoustic medicine; sonophoresis for nonsteroidal anti-inflammatory drug delivery in arthritis. [2023]

5. United Arab Emirates 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effect with high intensity focused ultrasound-mediated pulsatile delivery of diclofenac. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical Diathermy Performance Evaluation of Multi-hour Sustained Acoustic Medicine Treatment with 2.5% Diclofenac Ultrasound Coupling Patch. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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