Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis

University of Arizona1 site in 1 country208 target enrollmentAugust 13, 2020

ConditionsOsteo Arthritis Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteo Arthritis Knee
Sponsor: University of Arizona
Enrollment: 208
Locations: 1
Primary Endpoint: Change in Numeric Rating Score (NRS) of Pain
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 13, 2020

End Date

January 30, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Arizona

Responsible Party

Principal Investigator

Hyochol Ahn

Dean & Professor

University of Arizona

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Numeric Rating Score (NRS) of Pain

Time Frame: baseline, week 2 (after 10 tDCS sessions)

The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement.