Acoustic Therapy for Knee Osteoarthritis

Recruiting at 2 trial locations

Overseen By George K Lewis, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ZetrOZ, Inc.

Must not be taking: Steroids, Opioids

Disqualifiers: Pregnancy, Non-ambulatory, Pacemaker, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 24 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 knee treatments like electrical stimulation or traditional ultrasound.

What prior data suggests that this ultrasound device is safe for treating knee osteoarthritis?

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.

No major safety issues have been reported with these treatments. Most people using SAM alone or with the diclofenac patch found them safe and easy to handle. This suggests both treatments are safe options for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

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.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

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. ^{1 2 4 6 7}

Who Is on the Research Team?

George K Lewis, Ph.D.

Principal Investigator

ZetrOZ Systems

Are You a Good Fit for This Trial?

This trial is for individuals with knee pain due to osteoarthritis. Participants should be seeking treatment for their condition and willing to use the study's devices and patches as directed.

Inclusion Criteria

Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA

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

My doctor says I have mild to moderate knee arthritis.

Exclusion Criteria

Has a pacemaker

Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening

Is a prisoner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection including pain score before treatment

1 day

1 visit (in-person)

Treatment

Participants self-apply the SAM device and diclofenac patch for 4 hours daily over 24 weeks

24 weeks

Regular self-application, assessments at 8, 16, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sustained Acoustic Medicine

Trial Overview The study is testing a low intensity therapeutic ultrasound device (LITUS) combined with either a placebo patch or a diclofenac patch, which contains medication, over 24 weeks to see if it can reduce knee pain and improve joint function.

How Is the Trial Designed?

Group I: SAM Ultrasound Device and Diclofenac Patch Experimental Treatment 1 Intervention

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 24 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts/cm\^2 intensity.

Group II: SAM Ultrasound Device and SAM Patch Active Control 1 Intervention

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 24 weeks combined with SAM patch (0% diclofenac).

Group III: Diclofenac Patch Active Control 1 Intervention

Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.

Group IV: SAM Patch Placebo Group 1 Intervention

Patients wear 0% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.

Who Is Running the Clinical Trial?

ZetrOZ, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+

Published Research Related to This Trial

Therapeutic ultrasound significantly reduces knee pain in patients with osteoarthritis, with a strong effect size (SMD = -0.93) based on a systematic review of 10 randomized controlled trials involving 645 patients.

The treatment also improves physical function, as indicated by a reduction in the Western Ontario and McMaster Universities physical function score (SMD = -0.37), and no adverse events were reported, suggesting it is a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic ultrasound on pain, physical functions and safety outcomes in patients with knee osteoarthritis: a systematic review and meta-analysis. Zhang, C., Xie, Y., Luo, X., et al.[2018]

Ultrasound therapy significantly alleviates symptoms of knee osteoarthritis, as shown by improvements in the visual analogue scale (VAS) and Lequesne scores in a study of 87 patients.

The treatment led to reduced joint swelling, increased mobility, and decreased inflammation, with significant differences observed between the ultrasound group and the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ultrasound in the treatment of osteoarthritis of the knee. Yang, PF., Li, D., Zhang, SM., et al.[2021]

In a study involving 96 patients with knee osteoarthritis, therapeutic pulsed ultrasound did not show any significant benefits over sham ultrasound in reducing pain or improving function after 12 weeks of treatment.

Both the pulsed ultrasound and sham groups experienced improvements in pain and function, but there was no difference between the two groups, indicating that pulsed ultrasound may not be an effective treatment for knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of pulsed ultrasound treatment on pain, function, synovial sac thickness and femoral cartilage thickness in patients with knee osteoarthritis: a randomized, double-blind clinical, controlled study. Karakaş, A., Dilek, B., Şahin, MA., et al.[2022]

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]

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]

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/PMC7574225/

Sustained acoustic medicine as a non- ... In patients with osteoarthritis, SAM treatment demonstrated improved pain and functional gains compared to SOC but at an increased cost.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8684070/

Sustained acoustic medicine for the treatment of ... Sustained Acoustic Medicine treatment provides tissue heating and tissue recovery, improved patient function and reduction of pain.

4. 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 ...

5. openorthopaedicsjournal.com openorthopaedicsjournal.com/VOLUME/14/PAGE/176/FULLTEXT/

Sustained Acoustic Medicine Combined with A Diclofenac ... The authors concluded that regular ultrasound treatment is safe and effective at relieving pain and improving physical function in patients with ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223019.pdf

June 23, 2023 ZetrOZ Systems, LLC Sabrina Lewis QAR ... The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for ...

7. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/medical-policies/Stationary-Ultrasonic-Diathermy-Devices.pdf

7.01.174 Stationary Ultrasonic Diathermy Devices Several stationary ultrasonic diathermy devices have been granted 510(k) clearance by the United. States Food and Drug Administration (FDA) ...