Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
NCT ID: NCT04375072
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
208 participants
INTERVENTIONAL
2020-08-13
2025-01-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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active tDCS paired with active MBM,
active tDCS paired with active MBM
Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
sham tDCS paired with active MBM
sham tDCS paired with active MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds during each 20-minute session, conducted daily for 2 weeks. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
active tDCS paired with sham MBM
active tDCS paired with sham MBM
Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
sham tDCS paired with sham MBM
sham tDCS paired with sham MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds during each 20-minute session, conducted daily for 2 weeks. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
Interventions
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active tDCS paired with active MBM
Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
sham tDCS paired with active MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds during each 20-minute session, conducted daily for 2 weeks. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
active tDCS paired with sham MBM
Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
sham tDCS paired with sham MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds during each 20-minute session, conducted daily for 2 weeks. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
Eligibility Criteria
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Inclusion Criteria
* have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain,
* can speak and read English
* have no plan to change medication regimens for pain throughout the trial
Exclusion Criteria
* systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia
* alcohol/substance abuse
* diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23)
* pregnancy or lactation
* prosthetic knee replacement or non-arthroscopic surgery to the affected knee
* hospitalization within the preceding year for psychiatric illness
* no access to a device that can be used for secure videoconferencing for real-time remote supervision.
50 Years
85 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Arizona
OTHER
Responsible Party
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Hyochol Ahn
Dean & Professor
Principal Investigators
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Hyochol Ahn, PhD,RN,MSN
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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