Long-Duration Ultrasound for Knee Osteoarthritis

Inclusion Criteria:

- Are you between 35 and 80 years of age (inclusive)?

- Can you speak, read, and write in English?

- Do you have knee pain that has lasted at least 3 months?

- Are you willing and able to self-administer the ultrasound device daily within your
place of residence or during normal daily activity?

- Are you willing to keep all pain medications stable and discuss with the investigator
any needs to change medications during the study period? This may include drugs
administered topically, orally, transdermally, or by injection.

- Are you willing to document usage of any medications during the study period?

- Do you agree to discontinue all other interventional treatment modalities on the lower
back during the study? (e.g., transcutaneous electric nerve stimulation [TENS],
electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic
services)

- On a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (pain as bad as you can imagine),
how would you rate your average pain over the past week? Pain must be ≥4 for the
subject to be enrolled in this study. This criterion will be assessed by self-report
at Visit 1.

Exclusion Criteria:

- Have you participated in a clinical trial for an investigational drug and/or agent
within 30 days prior to screening?

- Are you pregnant?

- Are you a prisoner?

- Are you non-ambulatory (unable to walk)?

- Do you have a pacemaker?

- Do you have a malignancy in the treatment area?

- Do you have an active infection, open sores, or wounds in the treatment area?

- Do you have impaired sensation in the treatment area, such as caused by chemotherapy
or anesthesia?

- Do you have a known neuropathy (disease of the brain or spinal nerves)?

- Do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)?

- Do you have peripheral artery disease?

- Does the subject display 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?