Status:
COMPLETED
Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the feasibility, safety, and preliminary efficacy of a two-week self Cranial Electrical Stimulation(CES) on pain in older adults with knee osteoarthritis(OA)
Eligibility Criteria
Inclusion
- have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
- have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
- can speak and read English
- have a device with internet access that can be used for secure video conferencing for real- time remote supervision
- have no plan to change medication regimens for pain throughout the trial
- are able to travel to the coordinating center
- are willing and able to provide written informed consent prior to enrollment
Exclusion
- history of brain surgery, brain tumor, seizure,stroke, or intracranial metal implantation
- serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg)heart failure, or history of acute myocardial infarction
- alcohol/substance abuse
- cognitive impairment
- pregnancy or lactation
- hospitalization within the preceding year for psychiatric illness
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04016259
Start Date
August 1 2019
End Date
November 21 2019
Last Update
November 16 2020
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030