Veteran Affairs Osteoarthritis Knee Study

Avazzia

Status

Unknown

Conditions

Knee Osteoarthritis

Treatments

Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04698733

RA-191011-01-VA-OA-Knee

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.