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
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring electric stimulation, microcurrent, knee pain, knee injury
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.
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
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
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
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.
Time Frame
12 weeks
Title
Changes in patient-relevant outcomes
Description
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.
Time Frame
12 weeks
Title
Changes in brief pain inventory
Description
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".
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
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
Email
arelly@avazzia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elonm M Gbedey, BA
Phone
2148570304
Email
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
Email
elomn.gbedey@va.gov
First Name & Middle Initial & Last Name & Degree
Thiru Annaswamy, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Veteran Affairs Osteoarthritis Knee Study
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