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Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Osteo Arthritis Knee

Treatments

Device: Cranial Electrical Stimulation (CES)
Device: Sham-CES

Study type

Interventional

Funder types

Other

Identifiers

NCT04016259
HSC-SN-19-0452

Details and patient eligibility

About

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)

Enrollment

30 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups, including a placebo group

Self-CES
Experimental group
Treatment:
Device: Cranial Electrical Stimulation (CES)
Sham-CES
Placebo Comparator group
Treatment:
Device: Sham-CES

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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