| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteo Arthritis Knee | Device: Cranial Electrical Stimulation (CES) Device: Sham-CES | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | August 1, 2019 |
| Actual Primary Completion Date : | November 21, 2019 |
| Actual Study Completion Date : | November 21, 2019 |
| 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 Name: Alpha-Stim M
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| 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 Name: Alpha-Stim M
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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).
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).
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).
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).]
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
| Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| United States, Texas | |
| The University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Hyochol Ahn, PhD, RN, MSN | The University of Texas Health Science Center, Houston |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 9, 2019 | ||||||
| First Posted Date ICMJE | July 11, 2019 | ||||||
| Results First Submitted Date ICMJE | October 21, 2020 | ||||||
| Results First Posted Date ICMJE | November 16, 2020 | ||||||
| Last Update Posted Date | November 16, 2020 | ||||||
| Actual Study Start Date ICMJE | August 1, 2019 | ||||||
| Actual Primary Completion Date | November 21, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain) | ||||||
| Official Title ICMJE | Self Cranial Electrical Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain) | ||||||
| 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) | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Osteo Arthritis Knee | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
30 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | November 21, 2019 | ||||||
| Actual Primary Completion Date | November 21, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04016259 | ||||||
| Other Study ID Numbers ICMJE | HSC-SN-19-0452 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Hyochol Ahn, The University of Texas Health Science Center, Houston | ||||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | The University of Texas Health Science Center, Houston | ||||||
| Verification Date | October 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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