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

Study Overview
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Brief Summary
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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).

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Self Transcranial Direct Current Stimulation (tDCS)
* Behavioral: mindfulness-based meditation
* Device: Sham Self Transcranial Direct Current Stimulation (tDCS)
* Behavioral: sham meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS with mindfulness-based meditation<br>Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation | Device: Self Transcranial Direct Current Stimulation (tDCS)<br>* 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.<br>Behavioral: mindfulness-based meditation<br>* 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.<br>|
| Sham Comparator: sham tDCS with sham meditation<br>Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation | Device: Sham Self Transcranial Direct Current Stimulation (tDCS)<br>* 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.<br>Behavioral: sham meditation<br>* 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.<br>|

What is the study measuring?
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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 |