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Device

Sustained Acoustic Device with 2.5% Diclofenac Patch for Osteoarthritis

Phase 1
Waitlist Available
Led By Sandra Winkler, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 8 weeks
Awards & highlights

Summary

This trial will compare two methods of treating symptoms of knee osteoarthritis: Sustained Acoustic Medicine (SAM) vs a topical pain relief gel. Pain and function scores will be measured to determine which method is more effective.

Eligible Conditions
  • Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)

Trial Design

3Treatment 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 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Group II: Over the Counter Arthritis Pain GelActive Control1 Intervention
Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
Group III: Placebo SAM Ultrasound Device and Diclofenac PatchPlacebo Group1 Intervention
Patients receive placebo treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 0% diclofenac patch.
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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ZetrOZ, Inc.Lead Sponsor
15 Previous Clinical Trials
1,235 Total Patients Enrolled
7 Trials studying Osteoarthritis
802 Patients Enrolled for Osteoarthritis
Sandra Winkler, Ph.D.Principal InvestigatorJames A. Haley Veterans Hospital
~9 spots leftby Jul 2025
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