Clinical Trial Finder

Inclusion Criteria:

• - Have a prior diagnosis (Dx) of OA of the knee and have had a trial of conservative treatment for a minimum of 6 months without successful results due to continuing symptoms that interfere with normal function.

• - Age >18 - <70 years old.

• - Males/Females of all ethnicities.

• - NRS pain score of 3 or greater while on medication.

• - Ability to understand the informed consent document before signing it.

• - For female participants, is at least 4 years post-menopausal, has a history of hysterectomy, has had bilateral tubal ligation, or consents to use two forms of birth control.

Exclusion Criteria:

• - Poor diabetic control (A1c>11 within the last 3 months) - Diagnosis of acute sciatica and/or acute vasculitis.

• - Diabetic peripheral neuropathy.

• - Lower extremity surgery within the last 6 months.

• - Knee replacement.

• - Uncontrolled mood disorders, such as depression, anxiety.

• - Drug or substance abuse within past 90 days.

• - Injury that results in a change in pain level due to causes other than osteoarthritis (i.e., a recent fall or accident) - Epilepsy.

• - Open wounds around knee joint.

• - Active litigation, workers compensation.

• - An electrically implanted device such as a pacemaker, neural stimulator, etc. - Currently pregnant, nursing, or may become pregnant.

The primary objective of this study is to document the possible short- and long-term decrease in pain as scored by participants on a Numeric Rating Scale (NRS) after use of Avazzia PRO-Sport Ultra® device with pulsed microcurrent in patients with osteoarthritis of the knee. Patients with a clinical diagnosis of Osteoarthritis (OA) of the knee for a minimum of 6 months will be recruited for this study. Their OA has not responded/is not responding to treatment and continuing symptoms interfere with normal function. Additionally, patients will have a pain score of 3 or greater on the NRS even with pain medication. Secondary objectives include changes in:

• - Mobility via a Timed Up & Go assessment (TUG).

Participants are timed getting up from sitting in a standard armchair, walking approximately 3 meters, turning, walking back to the chair, and sitting down.

• - Patient-relevant outcomes via the Knee Injury and Osteoarthritis Outcome Score (KOOS).

The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.

• - Brief Pain Inventory - Short Form.

• - Use of pain medication.

Arms

Experimental: Experimental: BEST™ Pro-Sport Ultra® microcurrent device

Participants will receive 2 treatments a week on nonconsecutive days for 6 weeks in the clinic with an active electrical stimulation device.

Interventions

Device: - BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device

Participants will receive two (2) 20-minute treatments a week on nonconsecutive days for 6 weeks in the clinic. At the end of 6 weeks, participants will have a 6-week pause in treatment. Active Avazzia PRO-Sport Ultra® medical device, BEST™ HVPC microcurrent electrical stimulation, FDA cleared for pain relief