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Veteran Affairs Osteoarthritis Knee Study

Primary Purpose

Knee Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring electric stimulation, microcurrent, knee pain, knee injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Veteran Affairs North Texas Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: BEST™ Pro-Sport Ultra® microcurrent device

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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".

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.

Full Information

NCT ID

NCT04698733

First Posted

January 5, 2021

Last Updated

March 4, 2021

Sponsor

Avazzia, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04698733

Brief Title

Veteran Affairs Osteoarthritis Knee Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avazzia, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

electric stimulation, microcurrent, knee pain, knee injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: BEST™ Pro-Sport Ultra® microcurrent device

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention 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

Primary Outcome Measure Information:

Title

Pain Level Assessment

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Changes in mobility

Description

Time Frame

12 weeks

Title

Changes in patient-relevant outcomes

Description

Time Frame

12 weeks

Title

Changes in brief pain inventory

Description

Time Frame

12 weeks

Title

Changes in the use of pain medication

Description

Medication usage will be recorded during visits #1, 12, 13 and any increase/decrease in pain medications will be assessed.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arelly Villarreal, BS

Phone

2145752820

arelly@avazzia.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elonm M Gbedey, BA

Phone

2148570304

elonm.gbedey@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thiru Annaswamy, MD

Organizational Affiliation

Veteran Affairs North Texas Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veteran Affairs North Texas Healthcare System

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elomn M Gbedey

Phone

214-857-0304

elomn.gbedey@va.gov

First Name & Middle Initial & Last Name & Degree

Thiru Annaswamy, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Veteran Affairs Osteoarthritis Knee Study

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