NCT04698733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

January 5, 2021

Last Update Submit

March 4, 2021

Conditions

Knee Osteoarthritis

Keywords

electric stimulationmicrocurrentknee painknee injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (4)

  • Changes in mobility

    12 weeks

  • Changes in patient-relevant outcomes

    12 weeks

  • Changes in brief pain inventory

    12 weeks

  • Changes in the use of pain medication

    12 weeks

Study Arms (1)

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.

Device: BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device

Interventions

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

Experimental: BEST™ Pro-Sport Ultra® microcurrent device

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veteran Affairs North Texas Healthcare System

Dallas, Texas, 75216, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeKnee Injuries

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and Injuries

Study Officials

  • Thiru Annaswamy, MD

    Veteran Affairs North Texas Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arelly Villarreal, BS

CONTACT

2145752820arelly@avazzia.com

Elonm M Gbedey, BA

CONTACT

2148570304elonm.gbedey@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

February 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)