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Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Behavioral: mindfulness-based meditation
Device: Sham Self Transcranial Direct Current Stimulation (tDCS)
Behavioral: sham meditation
Device: Self Transcranial Direct Current Stimulation (tDCS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03747640
HSC-SN-18-0885

Details and patient eligibility

About

The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).

Enrollment

30 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
  • have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
  • can speak and read English
  • have a device with internet access that can be used for secure video conferencing for real-time remote supervision
  • have no plan to change medication regimens for pain throughout the trial
  • are able to travel to the coordinating center
  • are willing and able to provide written informed consent prior to enrollment

Exclusion criteria

  • Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
  • history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
  • serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
  • alcohol/substance abuse
  • cognitive impairment
  • pregnancy or lactation
  • hospitalization within the preceding year for psychiatric illness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

tDCS with mindfulness-based meditation
Experimental group
Description:
Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
Treatment:
Device: Self Transcranial Direct Current Stimulation (tDCS)
Behavioral: mindfulness-based meditation
sham tDCS with sham meditation
Sham Comparator group
Description:
Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
Treatment:
Behavioral: sham meditation
Device: Sham Self Transcranial Direct Current Stimulation (tDCS)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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