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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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. Secondary objectives are to assess the ability of LITUS to improve joint function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ZetrOZ, Inc.
• Treatments: Diclofenac

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 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

• 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).

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 a secondary cause of arthritis (metabolic or inflammatory)