Knee OsteoarthritisNCT04698733
Veteran Affairs Osteoarthritis Knee Study
A study testing BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device in people with Knee Osteoarthritis, run by Avazzia, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veteran Affairs North Texas Healthcare System
Dallas, Texas, 75216
Elomn M Gbedey, 214-857-0304, elomn.gbedey@va.gov
Thiru Annaswamy, MD
About this study
Official title: Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device
- Keywords
- electric stimulation, microcurrent, knee pain, knee injury
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: BEST™ Pro-Sport Ultra® microcurrent device | Experimental | Participants will receive 2 treatments a week on nonconsecutive days for 6 weeks in the clinic with an active electrical stimulation device. Receives: Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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".
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Feb 2021
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avazzia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thiru Annaswamy, MD, Principal investigator, Veteran Affairs North Texas Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698733
- Sponsor's protocol ID
- RA-191011-01-VA-OA-Knee
- Status last verified
- Mar 2021
- First submitted
- 5 Jan 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Pulsed Microcurrent in the Non-Invasive Treatment of Knee Pain From Osteoarthritis
- ClinicalTrials.gov ID
- NCT04698733
- Acronym / sponsor ID
- RA-191011-01-VA-OA-Knee
- Conditions
- Knee Osteoarthritis
- Keywords
- electric stimulation, microcurrent, knee pain, knee injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Avazzia, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: BEST™ Pro-Sport Ultra® microcurrent device | Experimental | Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® deviceParticipants will receive 2 treatments a week on nonconsecutive days for 6 weeks in the clinic with an active electrical stimulation device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® deviceParticipants 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 | Device | Experimental: BEST™ Pro-Sport Ultra® microcurrent device |
Primary outcome
Pain Level Assessment
Time frame: 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.
4 secondary outcomes
Changes in mobility
Time frame: 12 weeks
Changes in patient-relevant outcomes
Time frame: 12 weeks
Changes in brief pain inventory
Time frame: 12 weeks
Changes in the use of pain medication
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiru Annaswamy, MD principal investigator
Veteran Affairs North Texas Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device in people with Knee Osteoarthritis, run by Avazzia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arelly Villarreal, BS (2145752820, arelly@avazzia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level Assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.