Veteran Affairs Osteoarthritis Knee Study
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device
- Registration Number
- NCT04698733
- Lead Sponsor
- Avazzia, Inc
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental: BEST™ Pro-Sport Ultra® microcurrent device BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device Participants will receive 2 treatments a week on nonconsecutive days for 6 weeks in the clinic with an active electrical stimulation device.
- Primary Outcome Measures
Name Time Method Pain Level Assessment 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Changes in patient-relevant outcomes 12 weeks 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.
Changes in mobility 12 weeks 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.
Changes in the use of pain medication 12 weeks Medication usage will be recorded during visits #1, 12, 13 and any increase/decrease in pain medications will be assessed.
Changes in brief pain inventory 12 weeks 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".
Trial Locations
- Locations (1)
Veteran Affairs North Texas Healthcare System
🇺🇸Dallas, Texas, United States