Veteran Affairs Osteoarthritis Knee Study

Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arelly Villarreal, BS; Phone Number: 2145752820; Email: arelly@avazzia.com
• Study Contact Backup: Name: Elonm M Gbedey, BA; Phone Number: 2148570304; Email: elonm.gbedey@va.gov

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216
      • Recruiting
      • Veteran Affairs North Texas Healthcare System
      • Contact: Elomn M Gbedey; Phone Number: 214-857-0304; Email: elomn.gbedey@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Assessment	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mobility	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.	12 weeks
Changes in patient-relevant outcomes	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.	12 weeks
Changes in brief pain inventory	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".	12 weeks
Changes in the use of pain medication	Medication usage will be recorded during visits #1, 12, 13 and any increase/decrease in pain medications will be assessed.	12 weeks

Collaborators and Investigators

• Sponsor: Avazzia, Inc
• Investigators: Principal Investigator: Thiru Annaswamy, MD, Veteran Affairs North Texas Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: microcurrent; electric stimulation; knee pain; knee injury
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RA-191011-01-VA-OA-Knee

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes