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Behavioural Intervention

SAM + Diclofenac for 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
Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
Are between 35-80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 8 weeks
Awards & highlights

Study Summary

This trial tests if low-intensity ultrasound can reduce knee Osteoarthritis pain and improve joint function over 8 weeks.

Who is the study for?
This trial is for adults aged 35-80 with mild to moderate knee osteoarthritis, experiencing pain levels of 3-7. Participants must not use other topical treatments or pain medications and should be able to self-administer the device daily without assistance.Check my eligibility
What is being tested?
The study tests a Sustained Acoustic Medicine (SAM) device combined with either a real or placebo Diclofenac patch versus just the Diclofenac patch alone, aiming to reduce knee pain and improve joint function over eight weeks.See study design
What are the potential side effects?
Potential side effects may include skin irritation at the application site from the SAM device or patches, as well as typical side effects of Diclofenac like digestive issues, dizziness, and liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor says I have mild to moderate knee arthritis.
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I am between 35 and 80 years old.
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I agree not to use any skin products other than what's given to me in the study.
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I can take my treatment by myself every day, except when in water.
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I am not using and will not start using painkillers.
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I agree to stop any knee treatments like TENS during the study.

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
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/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 8 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 8 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

Find a Location

Who is running the clinical trial?

ZetrOZ, Inc.Lead Sponsor
15 Previous Clinical Trials
1,065 Total Patients Enrolled
2 Trials studying Arthritis
334 Patients Enrolled for Arthritis
George K Lewis, Ph.D.Principal InvestigatorZetrOZ Systems
2 Previous Clinical Trials
360 Total Patients Enrolled
1 Trials studying Arthritis
300 Patients Enrolled for Arthritis

Media Library

Sustained Acoustic Medicine (SAM) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05882812 — Phase 2
Arthritis Research Study Groups: SAM Ultrasound Device and Diclofenac Patch, SAM Ultrasound Device and SAM Patch, Diclofenac Patch
Arthritis Clinical Trial 2023: Sustained Acoustic Medicine (SAM) Highlights & Side Effects. Trial Name: NCT05882812 — Phase 2
Sustained Acoustic Medicine (SAM) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05882812 — Phase 2

Frequently Asked Questions

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

Do the qualifications for this trial extend to people of advanced age?

"According to the enrollment criteria for this particular trial, candidates must be aged between 35 and 80 years old. There are 85 medical trials targeting minors under 18 and 934 studies focused on patients over 65."

Answered by AI

What possible adversities may patients experience when using the SAM Ultrasound Device and Diclofenac Patch?

"Taking into account the fact that this is merely a Phase 2 trial, our team has assigned SAM Ultrasound Device and Diclofenac Patch with a score of two in terms of safety. This indicates there are some available data points on its security but no evidence to support its efficacy."

Answered by AI

To what extent has recruitment been successful for this research project?

"Affirmative. According to clinicaltrials.gov, the trial that was posted on June 3rd 2022 is presently recruiting participants. 120 persons will need to be enrolled from three different sites for this study."

Answered by AI

Do I meet the criteria for enrollment in this clinical trial?

"To be a part of this study, patients must have arthritis and fall between the ages of 35 and 80. The recruitment process is seeking to enrol approximately 120 participants."

Answered by AI

Are there currently any vacancies to partake in this medical experimentation?

"As reported on clinicaltrials.gov, this examination is actively seeking enrolment and has been available since June 3rd 2022 with the most recent update occurring on May 20th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
ZetrOZ Systems
Cayuga Medical Center - Medical Pain Consultants
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
3+

What questions have other patients asked about this trial?

How long are screenings & any compensation available?
PatientReceived no prior treatments

Why did patients apply to this trial?

I am trying to avoid surgery. I have osteoarthritis in both knees, but the right one is getting unbearable.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
2023. "Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05882812.
~109 spots leftby Apr 2025
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