Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
Purpose
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)
Condition
- Osteo Arthritis Knee
Eligibility
- Eligible Ages
- Between 50 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Self-CES |
|
|
Placebo Comparator Sham-CES |
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More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston