Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    200
  • sponsor
    Florida State University
Updated on 25 September 2021

Summary

The purpose of this study is to determine the effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness-based meditation (MBM) on clinical pain,osteo arthritis (OA)-related clinical symptoms, physiopsychological pain processing and participant satisfaction with treatment in patients with knee OA.

Details
Condition Osteo Arthritis Knee
Treatment active tDCS paired with active MBM, sham tDCS paired with active MBM, active tDCS paired with sham MBM, sham tDCS paired with sham MBM
Clinical Study IdentifierNCT04375072
SponsorFlorida State University
Last Modified on25 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

have symptomatic knee OA based on American College of Rheumatology clinical 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

history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia
alcohol/substance abuse
current use of sodium channel blockers, calcium channel blockers, or N-Methyl-D-aspartate receptor antagonists
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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