Knee Osteoarthritis Clinical Trial
Official title:
Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis
A clinical study at the Dallas Veterans Affairs, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® device by AVAZZIA to reduce pain and increase activity level in patients with knee osteoarthritis.
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. ;
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