← Back to Search

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
Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 8 weeks
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are between 35 and 80 years of age.\n
Select...
A pain score of 3-7 is frequent.
Select...
You are willing to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study.
Select...
You are willing and able to self-administer treatment daily within your place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
Select...
You are willing to discontinue any other interventional treatment modalities on the knee during the study period.

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over the age of fifty-five eligible to participate in this experiment?

"This clinical trial seeks patients aged 35 to 80. Participants younger than 18 have access to 38 other trials, and those older than 65 can choose from 656 studies."

Answered by AI

Is enrollment for this trial currently open?

"Affirmative. Per the details on clinicaltrials.gov, recruitment for this investigation is underway; it was launched on February 14th 2022 and subsequently updated the same day. The research team seeks 90 participants from 1 medical centre."

Answered by AI

What criteria must individuals meet to be considered for enrollment in this trial?

"This medical study seeks to enrol 90 patients suffering from arthrosis aged between 35 and 80. Prospective applicants must fulfil the following criteria: Have physician-diagnosed mild or moderate knee arthritis (OARSI atlas grades 1-2), Meet American College of Rheumatology's clinical and radiological diagnostic standards for knee OA, Report a frequent pain score between 3-7 during the week preceding entry, Demonstrate how their knee agony impairs quality of life, Be willing not to use any cream, gel or topical solution other than that provided at commencement of trial., Be deemed fit by a doctor to participate in this research"

Answered by AI

Has the Sustained Acoustic Device with 2.5% Diclofenac Patch been given regulatory clearance by the FDA?

"The safety of Sustained Acoustic Device with 2.5% Diclofenac Patch was rated a 1 according to our team's assessment at Power, as this is only Phase 1 trial and there are limited data verifying both its efficacy and security."

Answered by AI

What is the current enrollment level of this clinical experiment?

"Affirmative. The details uploaded to clinicaltrials.gov demonstrate that this medical trial, which was launched on February 14th 2022, is presently recruiting individuals for participation. 90 participants are sought from 1 distinct site."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Florida
How old are they?
65+
What site did they apply to?
James A Haley Veterans Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Pain and payment.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Can this trial be done from my home?
PatientReceived 1 prior treatment
Recent research and studies
~9 spots leftby Apr 2025