Ultrasound for Osteoarthritis

Not yet recruiting at 1 trial location

Overseen By Ralph Ortiz, DO, MPH

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: ZetrOZ, Inc.

Must not be taking: Steroids

Disqualifiers: Pregnancy, Non-ambulatory, Pacemaker, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the ability of long-duration high-frequency continuous-wave therapeutic ultrasound to alleviate knee Osteoarthritis pain over an 12-week period. The primary objective of this study is to evaluate the analgesic effect of ultrasound treatment in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of ultrasound treatment to improve joint function.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had frequent pain rated between 4 and 7 out of 10 in the past week.

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

I am willing to only use the provided ultrasound gel during treatment.

Exclusion Criteria

Has a pacemaker

I have cancer in the area that will be treated.

I have a diagnosed nerve or brain disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the SAM Ultrasonic Diathermy Device and either a diclofenac patch or SAM patch for 12 weeks. Treatment is self-applied for 4 hours daily, at least 5 days a week.

12 weeks

Daily self-application

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of pain and joint function.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Long Duration High Frequency Ultrasound

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 12 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 12 weeks combined with SAM patch (0% diclofenac).

Group III: Corticosteroid Injection Active Control 1 Intervention

Patients receive treatment of single intraarticular corticosteroid injection (triamcinolone acetonide)

Who Is Running the Clinical Trial?

ZetrOZ, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+