NCT05254574 · ZetrOZ, Inc.
Sustained Acoustic Medicine for Osteoarthritis Pain
What this study is about
The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.
View original scientific description
The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.
Interventions
DEVICE
Sustained Acoustic Device with 2.5% Diclofenac Patch
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.
DRUG
2.5% Diclofenac Patches
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
Primary outcome measures
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Time frame: Through 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: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
Where
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2025 · Source of record for eligibility and locations