Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis

Launched by ZETROZ, INC. · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called long-duration low intensity therapeutic ultrasound (LITUS) to help relieve knee pain caused by osteoarthritis, a common joint condition that affects many older adults. The aim is to see if this treatment can reduce pain and improve movement in participants over a 24-week period. If you are between 50 and 85 years old, have mild to moderate knee osteoarthritis, and often experience pain that affects your daily life, you might be eligible to participate.

Participants in this study will be expected to use the ultrasound device at home every day. They should be able to follow simple instructions for putting on and taking off the device. It's important to note that you cannot be using certain pain medications or other treatments for your knee during this trial. This study is still looking for volunteers, so if you're interested, please talk to your doctor to see if this might be a good option for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 50-85 years of age
• • Report a frequent pain score between 4-7 (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 ultrasound gel 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 use of 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).
• 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.
• • Is non-ambulatory (unable to walk).
• • 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 any contraindication to radiograph.
• • Have a secondary cause of arthritis (metabolic or inflammatory).