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

Trial Summary

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.

How is Sustained Acoustic Medicine treatment different from other treatments for knee osteoarthritis?

Sustained Acoustic Medicine is unique because it is a non-invasive, home-use ultrasound therapy that uses sound waves to stimulate healing and reduce pain in knee osteoarthritis. Unlike traditional treatments, it combines long-duration ultrasound with a diclofenac gel patch to enhance pain relief and improve joint function. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to assess the ability of long-duration low intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over a 24-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.

Research Team

George K Lewis, Ph.D.

Principal Investigator

ZetrOZ Systems

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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 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]

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]

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. England 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. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of ultrasound in the treatment of osteoarthritis of the knee. [2021]

4. 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]

5. England 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. [2018]