Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

University of Arizona208 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

208

Conditions

Osteo Arthritis Knee

Interventions

active tDCS paired with active MBMDEVICE

Active tDCS with a constant current intensity of 2 milli ampere (mA) will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.

sham tDCS paired with active MBMDEVICE

For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds during each 20-minute session, conducted daily for 2 weeks. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.

active tDCS paired with sham MBM

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Arizona

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Change in Numeric Rating Score (NRS) of Pain

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.

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

Secondary Outcomes

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 26 question index to assess knee OA pain (0-20 scale), function (0-68 scale), and stiffness (0-8 scale). The total WOAMC score is the sum of the 3 sub scales for a total score range from 0-96. Change in total WOMAC score = Week 2 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness.

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

Data from ClinicalTrials.gov

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