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Purpose

This clinical trial aims to evaluate whether a 2 week regimen of transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) can improve pain modulation, reduce clinical pain, and alleviate osteoarthritis (OA)-related symptoms in patients with knee OA.

Condition

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
active tDCS paired with active MBM,
  • Device: 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.
Active Comparator
sham tDCS paired with active MBM
  • Device: 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 Comparator
active tDCS paired with sham MBM
  • Device: 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 Comparator
sham tDCS paired with sham MBM
  • Device: 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.

More Details

Status
Completed
Sponsor
University of Arizona

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.