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

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Device: Sham Self Transcranial Direct Current Stimulation (tDCS)
Device: Self Transcranial Direct Current Stimulation (tDCS)
Behavioral: sham meditation
Behavioral: mindfulness-based meditation

Registration Number: NCT03747640

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

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS with sham meditation	Sham Self Transcranial Direct Current Stimulation (tDCS)	Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
sham tDCS with sham meditation	sham meditation	Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation
tDCS with mindfulness-based meditation	Self Transcranial Direct Current Stimulation (tDCS)	Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation
tDCS with mindfulness-based meditation	mindfulness-based meditation	Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form	2 weeks	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.
Psychosocial Symptoms as Assessed by PROMIS Depression-short Form	2 weeks	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.
Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)	2 weeks	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.
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)	baseline	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.
Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	baseline, 2 weeks	The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms.
Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form	baseline	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.
Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form	2 weeks	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.
Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy	2 weeks	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.
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee	baseline, 2 weeks	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).
Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee	baseline, 2 weeks	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).
Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)	2 weeks	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.
Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation	baseline, 2 weeks	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. \[To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm\^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).\]
Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity	baseline, 2 weeks	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.