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Behavioural Intervention
SAM Ultrasound Device and Diclofenac Patch for Arthritis
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 24 weeks.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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.
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)
Secondary outcome measures
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
Find a Location
Who is running the clinical trial?
ZetrOZ, Inc.Lead Sponsor
15 Previous Clinical Trials
965 Total Patients Enrolled
2 Trials studying Arthritis
234 Patients Enrolled for Arthritis
George K Lewis, Ph.D.Principal InvestigatorZetrOZ Systems
2 Previous Clinical Trials
260 Total Patients Enrolled
1 Trials studying Arthritis
200 Patients Enrolled for Arthritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 65 and above eligible for participation in this study?
"Participants aged over 25 years and under the age of 85 are eligible for enrollment in this research investigation."
Answered by AI
Are potential participants still able to enroll in this ongoing trial?
"The current information displayed on clinicaltrials.gov indicates that the trial is not actively seeking participants. The trial's initial posting was on February 19, 2024, and it was last revised on February 12, 2024. Despite this specific trial no longer enrolling patients, there are a substantial number of other trials – precisely 976 – presently open for enrollment."
Answered by AI
Have the SAM Ultrasound Device and Diclofenac Patch received clearance from the FDA for marketing?
"Our team has evaluated the safety of the SAM Ultrasound Device and Diclofenac Patch to be moderate, receiving a score of 2. This assessment is based on preliminary safety data as this trial is currently in Phase 2 with efficacy data yet to be established."
Answered by AI
What criteria must individuals meet to be eligible for participation in this research?
"Individuals aged between 25 and 85 years with a confirmed diagnosis of osteoarthritis are eligible to participate in this research study, which aims to enroll approximately 300 participants."
Answered by AI
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