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

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

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 Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: active tDCS paired with active MBM; Device: sham tDCS paired with active MBM; Device: active tDCS paired with sham MBM; Device: sham tDCS paired with sham MBM

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tDCS paired with active MBM,	Device: active tDCS paired with active MBM; 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.
Active Comparator: sham tDCS paired with active MBM	Device: sham tDCS paired with active MBM; 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 Comparator: active tDCS paired with sham MBM	Device: active tDCS paired with sham MBM; 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 sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
Sham Comparator: sham tDCS paired with sham MBM	Device: sham tDCS paired with sham MBM; 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 sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, week 2 (after 10 tDCS sessions)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, week 2 (after 10 tDCS sessions)

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Hyochol Ahn, PhD,RN,MSN, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: meditation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: STUDY00003164; R01NR019051 (U.S. NIH Grant/Contract); R01NR019051-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No