Veteran Affairs Osteoarthritis Knee Study

NCT ID: NCT04698733

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-11-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avazzia, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thiru Annaswamy, MD

Role: PRINCIPAL_INVESTIGATOR

Veteran Affairs North Texas Healthcare System

Locations

Veteran Affairs North Texas Healthcare System

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Arelly Villarreal, BS

Role: CONTACT

arelly@avazzia.com

2145752820

Elonm M Gbedey, BA

Role: CONTACT

elonm.gbedey@va.gov

2148570304

Facility Contacts

Elomn M Gbedey

Role: primary

elomn.gbedey@va.gov

214-857-0304

Other Identifiers

RA-191011-01-VA-OA-Knee

Identifier Type: -

Identifier Source: org_study_id