Status:
UNKNOWN
Veteran Affairs Osteoarthritis Knee Study
Lead Sponsor:
Avazzia, Inc
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 incre...
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® de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04698733
Start Date
February 1 2021
End Date
November 1 2021
Last Update
March 5 2021
Active Locations (1)
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1
Veteran Affairs North Texas Healthcare System
Dallas, Texas, United States, 75216