Veteran Affairs Osteoarthritis Knee Study

Status unconfirmed · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT04698733

Run by

Avazzia, Inc

People needed

60

Starts

2021-02-01

Expected to finish

2021-11-01

Last updated by the study team

2021-03-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Veteran Affairs North Texas Healthcare System — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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