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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT04016259
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Knee	Device: Cranial Electrical Stimulation (CES); Device: Sham-CES	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Self Cranial Electrical Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Nov 21, 2019
• Actual Study Completion Date: Nov 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-CES	Device: Cranial Electrical Stimulation (CES); CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).; Other Names: Alpha-Stim M
Placebo Comparator: Sham-CES	Device: Sham-CES; For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.; Other Names: Alpha-Stim M

Outcome Measures

Primary Outcome Measures

1. Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain [week 2]

   The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).

2. Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [week 2]

   The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms

Secondary Outcome Measures

1. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH) [week 2]

   In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH).

2. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO) [week 2]

   In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain" to assess their heat pain tolerance (HPTO).

3. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) [week 2]

   In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).

4. Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) [week 2]

   In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 12 degrees C for one minute. [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]

5. Psychosocial Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form [week 2]

   The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.

6. Psychosocial Symptoms as Measured by PROMIS - Depression Short Form [week 2]

   The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

7. Psychosocial Symptoms as Measured by PROMIS - Sleep Disturbance Short Form [week 2]

   The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely;3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.

8. Psychosocial Symptoms as Measured by the Pain Catastrophizing Scale (PCS) [week 2]

   The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. It is measured using the 0 (not at all) to 4 (all the time) scale. Total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.

9. 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 [baseline, week 2]

   Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.

10. Participant Satisfaction With Treatment Using the Client Satisfaction Questionnaire (CSQ-8) [week 2]

    The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction.

11. Feasibility as Measured by the Number of Participants That Completed the Full CES Protocol [week 2]

12. Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience [week 2]

    CES experience will be measured on a 10-item scale, with each item rated 0-10 and 0 being strongly disagree and 10 being strongly agree. Total score ranges from 0 to 100, with higher scores indicating a better CES experience. Question 1. It was easy to prepare the device and accessories Question 2. The device was unnecessarily complex Question 3. The device was easy to use Question 4. I felt the video conferences with a technical person were helpful Question 5. I would imagine that most people would learn to use this device quickly Question 6. The device was cumbersome to use Question 7. I felt confident using the device Question 8. I needed to learn a lot of things before I could get going with this device Question 9. The effectiveness of the treatment increased over the course of treatment Question 10. I felt that transcranial electrical stimulation treatment benefited me

13. Tolerability as Indicated by Number of Participants With Possible Side Effects of Treatment [week 2]

    Measurement of presence and severity of possible side effects of treatment on a 0 (not at all) to 10 (highest degree) scale.If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 5-point scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Hyochol Ahn, PhD, RN, MSN, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 28, 2019

More Information

Publications

None provided.

• Responsible Party: Hyochol Ahn, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04016259
• Other Study ID Numbers: HSC-SN-19-0452
• First Posted: Jul 11, 2019
• Last Update Posted: Nov 16, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sham-CES	Self-CES	Total
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.13 (5.83)	59.77 (6.88)	59.43 (6.27)
Sex: Female, Male (Count of Participants)
Female	10 66.7%	10 66.7%	20 66.7%
Male	5 33.3%	5 33.3%	10 33.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	0 0%	2 13.3%	2 6.7%
White	7 46.7%	8 53.3%	15 50%
African American	5 33.3%	3 20%	8 26.7%
Hispanic	3 20%	2 13.3%	5 16.7%
Region of Enrollment (Count of Participants)
United States	15 100%	15 100%	30 100%
Education (Count of Participants)
< High school	5 33.3%	6 40%	11 36.7%
2-Year College	1 6.7%	4 26.7%	5 16.7%
4-Year College	5 33.3%	2 13.3%	7 23.3%
Master's Degree	3 20%	2 13.3%	5 16.7%
Doctoral Degree	1 6.7%	1 6.7%	2 6.7%
Duration of Osteoarthritis (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	55.87 (40.64)	108 (103.87)	81.03 (80.86)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	33.66 (8.33)	32.56 (8.17)	33.11 (8.13)
Pain as Assessed by a Numerical Rating Scale (NRS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	34.67 (32.48)	44.33 (19.90)	39.50 (26.92)
Clinical pain assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	52.67 (21.413)	52.20 (17.604)	52.44 (19.5085)
Experimental Pain Sensitivity as measured by heat pain threshold (HPTH) (degree Celsius) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [degree Celsius]	40.12 (2.69)	38.34 (3.44)	39.23 (3.16)
Experimental Pain Sensitivity as measured by heat pain tolerance (HPTO) (degree Celsius) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [degree Celsius]	43.85 (3.26)	43.22 (3.15)	43.54 (3.16)
Experimental Pain Sensitivity as measured by pressure pain threshold (PPT) (kilogram-force (kgf)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram-force (kgf)]	1.86 (1.32)	1.60 (0.95)	1.73 (1.14)
Experimental Pain Sensitivity as measured by Conditioned Pain Modulation (CPM) (kilogram-force (kgf)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram-force (kgf)]	2.70 (1.26)	2.53 (0.86)	2.61 (1.06)
Psychosocial symptoms measured by the Patient-Reported Outcomes Measurement Info System - anxiety (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	15.67 (8.723)	12.27 (4.200)	13.97 (6.4615)
Psychosocial symptoms as measured by PROMIS - depression (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	12.73 (5.351)	10.53 (2.446)	11.63 (3.8985)
Psychosocial symptoms as measured by PROMIS - sleep disturbance (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	27.47 (7.029)	22.20 (8.187)	24.835 (7.608)
Psychosocial symptoms as measured by the Pain Catastrophizing Scale (PCS) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	18.40 (14.495)	13.80 (10.065)	16.10 (12.280)

Outcome Measures

1. Primary Outcome

Title	Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain
Description	The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [units on a scale]	40.40 (33.79)	27.33 (16.89)

2. Primary Outcome

Title	Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description	The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	47.40 (25.136)	43.80 (18.040)

3. Secondary Outcome

Title	Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
Description	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess HPTH, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH).
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [degree Celsius]	37.90 (2.03)	41.04 (3.17)

4. Secondary Outcome

Title	Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
Description	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess HPTO, heat stimuli were delivered to the participant's knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain" to assess their heat pain tolerance (HPTO).
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [degree Celsius]	43.05 (2.77)	44.56 (3.12)

5. Secondary Outcome

Title	Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
Description	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [kilograms force (kgf)]	1.06 (0.48)	2.59 (1.46)

6. Secondary Outcome

Title	Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
Description	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH), heat pain tolerance (HPTO), pressure pain threshold (PPT), and Conditioned Pain Modulation (CPM). CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 12 degrees C for one minute. [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [kilograms force (kgf)]	1.93 (0.90)	3.64 (1.67)

7. Secondary Outcome

Title	Psychosocial Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form
Description	The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	15.13 (6.770)	13.20 (4.663)

8. Secondary Outcome

Title	Psychosocial Symptoms as Measured by PROMIS - Depression Short Form
Description	The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	13.13 (5.449)	10.87 (2.642)

9. Secondary Outcome

Title	Psychosocial Symptoms as Measured by PROMIS - Sleep Disturbance Short Form
Description	The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely;3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	24.60 (6.566)	22.27 (7.126)

10. Secondary Outcome

Title	Psychosocial Symptoms as Measured by the Pain Catastrophizing Scale (PCS)
Description	The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. It is measured using the 0 (not at all) to 4 (all the time) scale. Total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	15.87 (15.505)	14.47 (10.789)

11. Secondary Outcome

Title	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
Description	Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
Time Frame	baseline, week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Count of Participants [Participants]	0 0%	15 100%

12. Secondary Outcome

Title	Participant Satisfaction With Treatment Using the Client Satisfaction Questionnaire (CSQ-8)
Description	The CSQ-8 comprises eight items that are summed to yield an overall score of 8-32, with higher scores indicating greater satisfaction.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	29.53 (2.264)	27.20 (4.843)

13. Secondary Outcome

Title	Feasibility as Measured by the Number of Participants That Completed the Full CES Protocol
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Count of Participants [Participants]	15 100%	15 100%

14. Secondary Outcome

Title	Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience
Description	CES experience will be measured on a 10-item scale, with each item rated 0-10 and 0 being strongly disagree and 10 being strongly agree. Total score ranges from 0 to 100, with higher scores indicating a better CES experience. Question 1. It was easy to prepare the device and accessories Question 2. The device was unnecessarily complex Question 3. The device was easy to use Question 4. I felt the video conferences with a technical person were helpful Question 5. I would imagine that most people would learn to use this device quickly Question 6. The device was cumbersome to use Question 7. I felt confident using the device Question 8. I needed to learn a lot of things before I could get going with this device Question 9. The effectiveness of the treatment increased over the course of treatment Question 10. I felt that transcranial electrical stimulation treatment benefited me
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Question 1	9.80 (0.56)	9.93 (0.26)
Question 2	0.00 (0.00)	0.00 (0.00)
Question 3	9.93 (0.29)	10.00 (0.00)
Question 4	8.73 (2.55)	9.27 (1.94)
Question 5	9.67 (0.62)	9.87 (0.52)
Question 6	0.27 (0.70)	0.07 (0.26)
Question 7	9.67 (1.29)	10.00 (0.00)
Question 8	0.53 (1.36)	0.20 (0.56)
Question 9	6.47 (3.50)	5.67 (4.35)
Question 10	5.80 (3.55)	6.33 (4.10)

15. Secondary Outcome

Title	Tolerability as Indicated by Number of Participants With Possible Side Effects of Treatment
Description	Measurement of presence and severity of possible side effects of treatment on a 0 (not at all) to 10 (highest degree) scale.If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 5-point scale.
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham-CES	Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.	Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
Measure Participants	15	15
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Sham-CES		Self-CES
Arm/Group Description	Sham-CES: For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.		Cranial Electrical Stimulation (CES): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
All Cause Mortality
	Sham-CES		Self-CES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Sham-CES		Self-CES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Sham-CES		Self-CES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

Small sample size; limited demographic (older adults with knee OA) restricts generalizability; slight deviations among intervals between daily stimulation sessions (though, this may be consistent with real-world use); long term efficacy not evaluated

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.