Knee OsteoarthritisPhase 1/2NCT05050448
Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain
A Phase 1/2 study testing Sustained Acoustic Device with 2.5% Diclofenac Patch and 1% Diclofenac Topical Gel in people with Knee Osteoarthritis, run by ZetrOZ, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Sustained Acoustic Device with 2.5% Diclofenac Patch and 1% Diclofenac Topical Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- 35-80 years of age
- Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
- Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
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- Deemed appropriate by their physician or by the study site physician to participate
- Willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device
- Not initiate use of opioid and/or non-opioid analgesic medications
- Willing to discontinue any other interventional treatment modalities on the knee during the study period
Who cannot join
- Cannot successfully demonstrate the ability to put on and take off the device
- Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- Is non-ambulatory (unable to walk)
- Is pregnant
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- Is a prisoner
- Has a pacemaker
- Has a malignancy in the treatment area
- Has an active infection, open sores, or wounds in the treatment area
- Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia
- Has known neuropathy
- Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage)
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
- Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
- Currently taking steroids
- Have contraindication to radiograph
- Have a secondary cause of arthritis (metabolic or inflammatory)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cayuga Medical Center - Medical Pain Consultants
Dryden, New York, 13053
Orthopaedic Foundation
Stamford, Connecticut, 06905
ZetrOZ Systems
Trumbull, Connecticut, 06611
About this study
Official title: Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis
The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.
- Conditions
- Knee Osteoarthritis
- Being tested
- Sustained Acoustic Device with 2.5% Diclofenac Patch, 1% Diclofenac Topical Gel
- Keywords
- Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Acoustic Device with 2.5% Diclofenac PatchDevice
Also called ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
1% Diclofenac Topical GelDrug
Also called Voltaren
Topical pain-relief gel
| Study group | Role | What they receive |
|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Experimental | 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. Receives: Device: Sustained Acoustic Device with 2.5% Diclofenac Patch |
| SAM2 Ultrasound Device and Diclofenac Patch | Experimental | Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour 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. Receives: Device: Sustained Acoustic Device with 2.5% Diclofenac Patch |
| Topical Pain-Relief Gel | Placebo comparator | Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. Receives: Drug: 1% Diclofenac Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.
Measured: 8 weeks
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Aug 2021
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George K Lewis, Ph.D., Principal investigator, ZetrOZ Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050448
- Sponsor's protocol ID
- HF-01-2021
- Status last verified
- Apr 2025
- First submitted
- 9 Sep 2021
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis
- ClinicalTrials.gov ID
- NCT05050448
- Acronym / sponsor ID
- HF-01-2021
- Conditions
- Knee Osteoarthritis
- Keywords
- Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Posted 2 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Experimental | Device: Sustained Acoustic Device with 2.5% Diclofenac PatchPatients 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. |
| SAM2 Ultrasound Device and Diclofenac Patch | Experimental | Device: Sustained Acoustic Device with 2.5% Diclofenac PatchPatients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour 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. |
| Topical Pain-Relief Gel | Placebo comparator | Drug: 1% Diclofenac Topical GelPatients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- 35-80 years of age
- Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
Key exclusion criteria (18 listed)
- Cannot successfully demonstrate the ability to put on and take off the device
- Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- Is non-ambulatory (unable to walk)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained Acoustic Device with 2.5% Diclofenac PatchAlso: ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS DevicePatients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches. | Device | SAM Ultrasound Device and Diclofenac Patch, SAM2 Ultrasound Device and Diclofenac Patch |
| 1% Diclofenac Topical GelAlso: VoltarenTopical pain-relief gel | Drug | Topical Pain-Relief Gel |
Primary outcome
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Time frame: 8 weeks
Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline
Time frame: 8 weeks
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Class II Medical DeviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George K Lewis, Ph.D. principal investigator
ZetrOZ Systems
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sustained Acoustic Device with 2.5% Diclofenac Patch and 1% Diclofenac Topical Gel in people with Knee Osteoarthritis, run by ZetrOZ, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.