Veteran Affairs Osteoarthritis Knee Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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.
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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.
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Brief Pain Inventory - Short Form
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Use of pain medication.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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".
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Age >18 - <70 years old
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Males/Females of all ethnicities
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NRS pain score of 3 or greater while on medication
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Ability to understand the informed consent document before signing it
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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:
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Poor diabetic control (A1c>11 within the last 3 months)
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Diagnosis of acute sciatica and/or acute vasculitis
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Diabetic peripheral neuropathy
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Lower extremity surgery within the last 6 months
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Knee replacement
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Uncontrolled mood disorders, such as depression, anxiety
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Drug or substance abuse within past 90 days
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Injury that results in a change in pain level due to causes other than osteoarthritis (i.e., a recent fall or accident)
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Epilepsy
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Open wounds around knee joint
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Active litigation, workers compensation
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An electrically implanted device such as a pacemaker, neural stimulator, etc.
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Currently pregnant, nursing, or may become pregnant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Veteran Affairs North Texas Healthcare System | Dallas | Texas | United States | 75216 |
Sponsors and Collaborators
- Avazzia, Inc
Investigators
- Principal Investigator: Thiru Annaswamy, MD, Veteran Affairs North Texas Healthcare System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RA-191011-01-VA-OA-Knee