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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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
Veteran Affairs North Texas Healthcare System
Dallas, Texas, United States
RECRUITINGPain Level Assessment
Change in pain associated with osteoarthritis of the knee during all visits (#1-13). Pain will be assessed with NRS (numeric rating scale) where 0 is no pain and 10 is worst possible pain.
Time frame: 12 weeks
Changes in mobility
Mobility will be assessed via Timed Up \& Go (TUG) assessment during visits #1, 12, 13. Participants are timed getting up from sitting in a standard armchair, walking approximately 3 meters, turning, walking back to the chair, and sitting down.
Time frame: 12 weeks
Changes in patient-relevant outcomes
Patient-relevant outcomes will be assessed via the Knee Injury and Osteoarthritis Outcome Score (KOOS) during visits #1, 12 and 13. 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. KOOS does not use a numerical scale, it uses a qualitative scale with the following options: never, rarely, sometimes, often and always.
Time frame: 12 weeks
Changes in brief pain inventory
The brief pain inventory (BPI) will be used to assess changes in pain during visits #1, 12, and 13. This scale ranges from 0 to 10. The numerical value 0 can represent "no pain" or "does not interfere". The numerical value 10 can represent "pain as bad as you can imagine" or completely interferes".
Time frame: 12 weeks
Changes in the use of pain medication
Medication usage will be recorded during visits #1, 12, 13 and any increase/decrease in pain medications will be assessed.
Time frame: 12 weeks
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