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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02512393
Eligibility Criteria:
Inclusion Criteria:
* they have self-reported unilateral or bilateral knee OA pain according to American College of Rheumatology criteria
* they can understand, speak and read English
* they are able to walk for 6-minutes
* they are willing to be randomized to either the intervention or control group
* they are available for five consecutive daily sessions and for a follow-up phone interview each week for three weeks post-stimulation sessions
* they have no plan to change medication regimens for pain throughout the trial
* they are willing and able to provide written informed consent
Exclusion Criteria:
* knee replacement or non-arthroscopic surgery to the affected knee
* serious medical illness, such as uncontrolled hypertension (i.e., Systolic Blood Pressure/Diastolic Blood Pressure of ≥ 150/95), congestive heart failure, pacemaker, or history of acute myocardial infarction
* peripheral neuropathy
* systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
* alcohol/substance abuse
* cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23)
* history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation
* pregnancy or lactation for females
* hospitalization within the preceding year due to psychiatric illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT02512393
Study Brief:
Protocol Section:
NCT02512393