Knee Osteoarthritis
Conditions
Keywords
electric stimulation, microcurrent, knee pain, knee injury
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.
Interventions
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
Sponsors
Avazzia, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level Assessment | 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in mobility | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | Medication usage will be recorded during visits #1, 12, 13 and any increase/decrease in pain medications will be assessed. |
Countries
United States
Contacts
Primary ContactArelly Villarreal, BS
Backup ContactElonm M Gbedey, BA
Outcome results
None listed