Clinical trial NCT04016259: Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
Official title: Self Cranial Electrical Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain
timeFrame: week 2
measure: Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: week 2
Secondary outcomes:
measure: Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
timeFrame: week 2
measure: Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
timeFrame: week 2
measure: Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
timeFrame: week 2
measure: Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
timeFrame: week 2
measure: Psychosocial Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form
timeFrame: week 2
measure: Psychosocial Symptoms as Measured by PROMIS - Depression Short Form
timeFrame: week 2
measure: Psychosocial Symptoms as Measured by PROMIS - Sleep Disturbance Short Form
timeFrame: week 2
measure: Psychosocial Symptoms as Measured by the Pain Catastrophizing Scale (PCS)
timeFrame: week 2
measure: Number of Participants With a Significant Change in Pain-related Cortical Response on Average as Assessed by a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
timeFrame: baseline, week 2
measure: Participant Satisfaction With Treatment Using the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: week 2
measure: Feasibility as Measured by the Number of Participants That Completed the Full CES Protocol
timeFrame: week 2
measure: Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
timeFrame: week 2
measure: Tolerability as Indicated by Number of Participants With Possible Side Effects of Treatment
timeFrame: week 2
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Hyochol Ahn, PhD, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References: