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NCT04375072 | RECRUITING | Osteo Arthritis Knee

Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
Sponsor:

University of Arizona

Information provided by (Responsible Party):

Hyochol Ahn

Brief 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.

Condition or disease

Osteo Arthritis Knee

Intervention/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

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2020-08-13
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2025-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
  • * 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.
Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

Location Details

NCT04375072

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How to Participate

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Locations

RECRUITING

United States, Arizona

University of Arizona

Tucson, arizona, United States, 85721