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Behavioural Intervention

Acoustic Therapy for Knee Osteoarthritis

Phase 2

Waitlist Available

Led By George K Lewis, Ph.D.

Research Sponsored by ZetrOZ, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not use or initiate use of opioid and/or non-opioid analgesic medications

Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)

Must not have

Is non-ambulatory (unable to walk)

Are currently taking steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 24 weeks.

Summary

This trial aims to see if long-duration low intensity therapeutic ultrasound (LITUS) can help reduce knee Osteoarthritis pain over 24 weeks. The main goal is to evaluate how well

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include skin irritation at the site of the patch or device application. Diclofenac patches could also cause local reactions like redness, itching, or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My doctor says I have mild to moderate knee arthritis.

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I am between 25 and 85 years old.

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to walk.

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I am currently on steroids.

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

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My arthritis is caused by another health condition.

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

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I have cancer in the area that will be treated.

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

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I have a diagnosed nerve condition.

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I have a genetic condition that causes excessive bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average of 24 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average of 24 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 24 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline

Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Secondary study objectives

Change in Depression Anxiety Stress Scale (DASS21)

Change in Global Rating of Change (GROC) on a Scale (-7 to +7)

Change in the Pain & Sleep Questionnaire (PSQ-3)

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sustained Acoustic Device with 2.5% Diclofenac Patch

2022

Completed Phase 2

~290