Clinical trial NCT04698733: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: electric stimulation
microcurrent
knee pain
knee injury
Lead sponsor: Avazzia, Inc
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Level Assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in mobility
timeFrame: 12 weeks
measure: Changes in patient-relevant outcomes
timeFrame: 12 weeks
measure: Changes in brief pain inventory
timeFrame: 12 weeks
measure: Changes in the use of pain medication
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Veteran Affairs North Texas Healthcare System
state: Texas
Study officials:
affiliation: Veteran Affairs North Texas Healthcare System
name: Thiru Annaswamy, MD
role: PRINCIPAL_INVESTIGATOR
References: