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

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

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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)