Status:
RECRUITING
Sustained Acoustic Medicine for Osteoarthritis Pain
Lead Sponsor:
ZetrOZ, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
35-85 years
Phase:
PHASE1
Brief Summary
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 scor...
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)
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05254574
Start Date
February 14 2022
End Date
May 31 2026
Last Update
February 27 2025
Active Locations (1)
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1
James A Haley Veterans Hospital
Tampa, Florida, United States, 33511