Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04698733
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04698733
Study Brief:
Protocol Section:
NCT04698733