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Completed

NCT Number: NCT04375072

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

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.

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Key information

Conditions

Osteo Arthritis Knee

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

active tDCS paired with active MBM

Device

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 MBM

Device

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

Device

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 tDCS paired with sham MBM

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 5, 2020
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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