Veteran Affairs Osteoarthritis Knee Study

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

Sponsors

Lead Sponsor: Avazzia, Inc

Source Avazzia, Inc
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.

Overall Status Not yet recruiting
Start Date January 2021
Completion Date November 2021
Primary Completion Date November 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain Level Assessment 12 weeks
Secondary Outcome
Measure Time Frame
Changes in mobility 12 weeks
Changes in patient-relevant outcomes 12 weeks
Changes in brief pain inventory 12 weeks
Changes in the use of pain medication 12 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Device

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

Description: 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

Arm Group Label: Experimental: BEST™ Pro-Sport Ultra® microcurrent 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thiru Annaswamy, MD Principal Investigator Veteran Affairs North Texas Healthcare System
Overall Contact

Last Name: Arelly Villarreal, BS

Phone: 2145752820

Email: [email protected]

Verification Date

January 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Experimental: BEST™ Pro-Sport Ultra® microcurrent device

Type: Experimental

Description: Participants will receive 2 treatments a week on nonconsecutive days for 6 weeks in the clinic with an active electrical stimulation device.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov