Veteran Affairs Osteoarthritis Knee Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: BEST™ Pro-Sport Ultra® microcurrent device<br>Participants will receive 2 treatments a week on nonconsecutive days for 6 weeks in the clinic with an active electrical stimulation device. | Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electric stimulation, microcurrent, knee pain, knee injury