Sustained Acoustic Medicine for Osteoarthritis Pain

This study is looking at how well Sustained Acoustic Medicine (SAM) combined with 2.5% Diclofenac patches works for osteoarthritis pain. It compares this treatment to using only 2.5% Diclofenac patches. You might be able to join if you are between 35 and 85 years old and have mild to moderate osteoarthritis in your knee, shoulder, elbow, ankle, hip, or spine, with frequent pain scores between 3 and 7. The study will measure changes in your pain and how well you can move over about 8 weeks. The current status of this study is unclear.

Study design: This interventional study plans to enroll 200 participants. It compares two different treatments for osteoarthritis pain.
What's involved: Patients will apply the SAM device daily for 1-4 hours with 2.5% Diclofenac patches, or wear 2.5% Diclofenac patches for 4 hours at least 5 days a week.
Compensation: Not stated in the trial record.
Follow-up: The study will measure pain and function through study completion, which is an average of 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Sustained Acoustic Medicine for Osteoarthritis Pain

Recruiting

PHASE1Ages 35–85InterventionalTreatment

ZetrOZ, Inc.

~200 participants

Updated 2025-02-27 on ClinicalTrials.gov

What's tested:Sustained Acoustic Device with 2.5% Diclofenac Patch2.5% Diclofenac Patches

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline

Measured over Through study completion, average of 8 weeks

+1 more outcome measured

Conditions

Osteoarthritis

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Sandra Winkler, Ph.D. · PRINCIPAL_INVESTIGATOR · James A. Haley Veterans Hospital

Who to contact

George K. Lewis, Ph.D.

[email protected]

888-202-9831

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).

Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA

Are between 35-85 years of age

Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment

Report that knee, shoulder, elbow, ankle, hip, or spine 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

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 treatment area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

Exclusion

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.

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, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months.

Requires oxygen support

Has an allergy to aspirin or other NSAIDs

Have a secondary cause of arthritis (metabolic or inflammatory)

What this trial measures

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From BaselineThrough study completion, average of 8 weeks
Change in the self described pain units on a scale by patient at baseline and post-
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Time Frame: Through study completion, average 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. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).

Trialytics