Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis

Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Meditation for Knee Pain)

The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Self Transcranial Direct Current Stimulation (tDCS); Behavioral: mindfulness-based meditation; Device: Sham Self Transcranial Direct Current Stimulation (tDCS); Behavioral: sham meditation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
• have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
• can speak and read English
• have a device with internet access that can be used for secure video conferencing for real-time remote supervision
• have no plan to change medication regimens for pain throughout the trial
• are able to travel to the coordinating center
• are willing and able to provide written informed consent prior to enrollment

Exclusion Criteria:

• Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
• history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
• serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
• alcohol/substance abuse
• cognitive impairment
• pregnancy or lactation
• hospitalization within the preceding year for psychiatric illness

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS with mindfulness-based meditation; Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation	Device: Self Transcranial Direct Current Stimulation (tDCS); tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.; Behavioral: mindfulness-based meditation; The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
Sham Comparator: sham tDCS with sham meditation; Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation	Device: Sham Self Transcranial Direct Current Stimulation (tDCS); 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.; Behavioral: sham meditation; For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)	The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).	baseline, 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms.	baseline, 2 weeks
Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form	The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.	baseline
Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form	The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.	2 weeks
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form	The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.	baseline
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form	The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.	2 weeks
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form	The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.	baseline
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form	The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.	2 weeks
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.	baseline
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.	2 weeks
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)	The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.	baseline
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)	The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.	2 weeks
Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation	Conditioned Pain Modulation (CPM) was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 12 degrees C for one minute. [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]	baseline, 2 weeks
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)	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 pain stimulation.	baseline
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy	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 pain stimulation.	2 weeks
Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity	Participants immersed their hand in a cold water bath, and at thirty seconds after hand immersion, they rated the cold pain intensity on a scale of 0-100. A higher score indicating higher pain intensity.	baseline, 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee	To assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).	baseline, 2 weeks
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee	To assess pressure pain threshold (PPT), a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's knee. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).	baseline, 2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HSC-SN-18-0885

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