Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis

The University of Texas System (UT)

Status: Completed

Conditions: Chronic Pain; Knee Osteoarthritis

Treatments: Device: Soterix 1x1 tDCS mini-CT Stimulator device

Study type: Interventional

Funder types: Other

Identifiers

NCT03425019

HSC-SN-17-1072

Details and patient eligibility

About

The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).

Enrollment: 21 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
• have had knee OA pain in the past 3 months with an average of at least 3 on a 10 cm Visual Analog Scale (VAS) 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 access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit
• 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

• previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee
• history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation
• systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
• uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg)
• heart failure
• history of acute myocardial infarction
• peripheral neuropathy
• alcohol/substance abuse
• cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23)
• pregnancy or lactation
• hospitalization within the preceding year for psychiatric illness

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Transcranial Direct Current Stimulation

Experimental group

Description:

Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.

Treatment:

Device: Soterix 1x1 tDCS mini-CT Stimulator device