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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, average of 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 8 weeks
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
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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
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Eligibility Criteria:
This trial includes the following eligibility 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 doctor says I have mild to moderate knee arthritis.I am between 35 and 80 years old.My pain level has been between moderate to severe in the past week.I agree not to use any skin products other than what's given to me in the study.I can take my treatment by myself every day, except when in water.I agree to stop any knee treatments like TENS during the study.My arthritis is caused by another health condition.I have a diagnosed nerve condition.My knee pain worsens my quality of life.I have a genetic condition that causes excessive bleeding.I am not using and will not start using painkillers.I haven't had knee surgery or injections in the affected knee in the last 6 months.I have numbness in the area to be treated, possibly due to chemotherapy or anesthesia.I cannot put on or take off the device by myself.I have cancer in the area that will be treated.You have been diagnosed with knee osteoarthritis by a doctor using specific guidelines from the American College of Rheumatology.
Research Study Groups:
This trial has the following groups:- Group 1: SAM Ultrasound Device and Diclofenac Patch
- Group 2: SAM Ultrasound Device and SAM Patch
- Group 3: Diclofenac Patch
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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