Osteo Arthritis KneePhase 2NCT05882812
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
A Phase 2 study testing Sustained Acoustic Device with 2.5% Diclofenac Patch, Sustained Acoustic Device with 0% Diclofenac Patch and 2.5% Diclofenac Patches in people with Osteo Arthritis Knee and Arthritis, run by ZetrOZ, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over an 8-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Arthritis
- What is being tested?
- Sustained Acoustic Device with 2.5% Diclofenac Patch, Sustained Acoustic Device with 0% Diclofenac Patch and 2.5% Diclofenac Patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2023to 22 Feb 2024
- Phase
- Phase 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
- 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
- Are between 35-80 years of age
- Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
- Are willing not 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
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- Are deemed appropriate by their physician or by the study site physician to participate.
- Be 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 use or initiate opioid and/or non-opioid analgesic medications.
- Be willing to discontinue any other interventional treatment modalities on the knee during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
Who cannot join
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays 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.
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Is pregnant.
- Is a prisoner.
- Is non-ambulatory (unable to walk).
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- 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 a known neuropathy (disease of the brain or spinal nerves).
- Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- Are currently taking steroids
- 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
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over an 8-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.
Read the detailed description
This is an 8-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 8 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the completion of treatment. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.
Over 120 subjects will be recruited from neighboring communities to the study sites. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals.
- Conditions
- Osteo Arthritis Knee, Arthritis
- Being tested
- Sustained Acoustic Device with 2.5% Diclofenac Patch, Sustained Acoustic Device with 0% Diclofenac Patch, 2.5% Diclofenac Patches
- Keywords
- Low-Intensity Ultrasound, Drug Delivery, Sonophoresis, Transdermal Drug Delivery, Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound
- Medical subject headings
- Arthritis
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 Wearable
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^2 with 2.5% Diclofenac patches.
Sustained Acoustic Device with 0% Diclofenac PatchDevice
Also called ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
2.5% Diclofenac PatchesDrug
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
| 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/cm^2 intensity. Receives: Device: Sustained Acoustic Device with 2.5% Diclofenac Patch |
| SAM Ultrasound Device and SAM Patch | Active comparator | 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). Receives: Device: Sustained Acoustic Device with 0% Diclofenac Patch |
| Diclofenac Patch | Active comparator | Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined. Receives: Drug: 2.5% Diclofenac Patches |
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 (Value at 8 Weeks Minus Value at Baseline).
Change in the self described pain units on a scale by patient at baseline and post-treatment. Higher scores mean a worse outcome.
Measured: End of 8 weeks
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at 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). Higher values represent a worse outcome, and lower values represent a better outcome.
Measured: End of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start3 Jun 2023
- Primary completion31 Dec 2023
- Study completion22 Feb 2024
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 Osteo Arthritis KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT05882812
- Sponsor's protocol ID
- KP-01-2022
- Status last verified
- Apr 2025
- First submitted
- 20 May 2023
- Last updated
- 15 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
- ClinicalTrials.gov ID
- NCT05882812
- Acronym / sponsor ID
- KP-01-2022
- Conditions
- Osteo Arthritis Knee, Arthritis
- Keywords
- Low-Intensity Ultrasound, Drug Delivery, Sonophoresis, Transdermal Drug Delivery, Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Posted 15 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 assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over an 8-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.
Detailed description
This is an 8-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 8 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the completion of treatment. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.
Over 120 subjects will be recruited from neighboring communities to the study sites. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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/cm^2 intensity. |
| SAM Ultrasound Device and SAM Patch | Active comparator | Device: Sustained Acoustic Device with 0% 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 SAM patch(0% diclofenac). |
| Diclofenac Patch | Active comparator | Drug: 2.5% Diclofenac PatchesPatients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Are between 35-80 years of age
- Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
Key exclusion criteria (15 listed)
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays 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.
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Is pregnant.
- Is a prisoner.
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 Device WearablePatients 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^2 with 2.5% Diclofenac patches. | Device | SAM Ultrasound Device and Diclofenac Patch |
| Sustained Acoustic Device with 0% Diclofenac PatchAlso: ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device WearablePatients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches. | Device | SAM Ultrasound Device and SAM Patch |
| 2.5% Diclofenac PatchesTopical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch. | Drug | Diclofenac Patch |
Primary outcome
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain (Value at 8 Weeks Minus Value at Baseline).
Time frame: End of 8 weeks
Change in the self described pain units on a scale by patient at baseline and post-treatment. Higher scores mean a worse outcome.
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at Baseline)
Time frame: End of 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). Higher values represent a worse outcome, and lower values represent a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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 2 study testing Sustained Acoustic Device with 2.5% Diclofenac Patch, Sustained Acoustic Device with 0% Diclofenac Patch and 2.5% Diclofenac Patches in people with Osteo Arthritis Knee and Arthritis, 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 15 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 15 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 15 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 (Value at 8 Weeks Minus Value at Baseline). (time frame: End of 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 15 May 2025.