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

Not Applicable

Completed

Conditions: Osteo Arthritis Knee

Interventions: Device: Active tDCS
Device: Sham tDCS

Registration Number: NCT04016272

Lead Sponsor: Florida State University

Brief Summary: The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 123

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

prosthetic knee replacement or nonarthroscopic surgery to the affected knee
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
current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
diminished cognitive function that would interfere with understanding study procedures(i.e., Mini-Mental Status Exam score ≤ 23)
pregnancy or lactation
hospitalization within the preceding year for psychiatric illness
no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Active tDCS	-
Sham tDCS	Sham tDCS	-

Primary Outcome Measures

Name	Time	Method
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain	baseline, week 3	The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System	Baseline, week1, week2, and week 3	Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal and punctate pain stimulation and correlation values will be presented in the form of figures. * Specify the full scale: Pearson correlation coefficient (r) between pairs of brain regions (fNIRS channels). * A value of r=0 indicates that two brain regions were functionally disconnected. * Greater absolute r values denote stronger connections. However, this does not indicate a better or worse result but only a different type of connectivity on a macroscale (when considering several fNIRS channels). * We used \\|r\\|\>0.3 (absolute value of r greater than 0.3) to extract meaningful functional connections.
Acceptability as Measured by the tDCs Experience Questionnaire	week 3	The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 questions resulting most desirable score of a 70.
Number of Participants With Possible Side Effects of Treatment	week 3	If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 10-point scale, from 0 (not at all) to 10 (to a high degree). The questionnaire ask to what extend did the participant experienced symptoms like, tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, or mood change.
Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol	week 3	We will calculate the percentage of participants who a) meet the inclusion criteria, b) agree to be randomly assigned, c) complete the full tDCS protocol, and d) attend the follow-up assessment.