Acoustic Therapy for Knee Osteoarthritis

Palo Alto (17 mi)

Overseen byGeorge K Lewis, Ph.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ZetrOZ, Inc.

Prior Safety Data

Trial Summary

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.

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

I do not use and will not start using opioid or non-opioid painkillers.

My doctor says I have mild to moderate knee arthritis.

I am between 25 and 85 years old.

My pain level has been between moderate to severe in the past week.

I agree to only use the provided ultrasound gel during the study.

I can take my treatment by myself every day, except when I'm in water.

I agree to stop any knee treatments like TENS during the study.

Exclusion Criteria

I am unable to walk.

I am currently on steroids.

I have an infection or open wounds in the area that would be treated.

My arthritis is caused by another health condition.

I cannot put on or take off the device by myself.

I have cancer in the area that will be treated.

I have numbness in the treatment area due to chemotherapy or anesthesia.

I have a diagnosed nerve condition.

I have a genetic condition that causes excessive bleeding.

Treatment Details

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.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: SAM Ultrasound Device and Diclofenac PatchExperimental Treatment1 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 PatchActive Control1 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 PatchActive Control1 Intervention

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

Group IV: SAM PatchPlacebo Group1 Intervention

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