Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT04698733
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Veteran Affairs Osteoarthritis Knee Study
Sponsor:
Avazzia, Inc
Organization:
Study Overview
Official Title:
Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: