N/A Completed N=30 Randomized Triple-blind Treatment

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

Osteo Arthritis Knee

Source: ClinicalTrials.gov NCT04016259 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcomePrimary: Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain — 40.40; 27.33 units on a scale

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)

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain	40.40; 27.33	—
PRIMARY Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	47.40; 43.80	—
SECONDARY Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)	37.90; 41.04	—
SECONDARY Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)	43.05; 44.56	—
SECONDARY Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)	1.06; 2.59	—
SECONDARY Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)	1.93; 3.64	—
SECONDARY Psychosocial Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form	15.13; 13.20	—
SECONDARY Psychosocial Symptoms as Measured by PROMIS - Depression Short Form	13.13; 10.87	—
SECONDARY Psychosocial Symptoms as Measured by PROMIS - Sleep Disturbance Short Form	24.60; 22.27	—
SECONDARY Psychosocial Symptoms as Measured by the Pain Catastrophizing Scale (PCS)	15.87; 14.47	—
SECONDARY 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	0; 15	—
SECONDARY Participant Satisfaction With Treatment Using the Client Satisfaction Questionnaire (CSQ-8)	29.53; 27.20	—
SECONDARY Feasibility as Measured by the Number of Participants That Completed the Full CES Protocol	15; 15	—
SECONDARY Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience	9.80; 9.93; 0.00; 0.00; 9.93; 10.00	—
SECONDARY Tolerability as Indicated by Number of Participants With Possible Side Effects of Treatment	0; 0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04016259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.