Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Study Overview
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Brief Summary
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Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty

Detailed Description
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The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.

Official Title
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Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: active tDCS paired with active MBM
* Device: sham tDCS paired with sham MBM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective unilateral knee total replacement mentally capable of reading, giving consent and following instructions being able to answer questions in English not pregnant 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 current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists hospitalization within the preceding year for psychiatric illness no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative active tDCS+MBI<br>Active tDCS with simultaneous meditation intervention will be applied. | Device: active tDCS paired with active MBM<br>* Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times 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 for 5 times by a recorded meditation.<br>|
| Sham Comparator: preoperative sham tDCS+MBI<br>Sham tDCS with simultaneous sham MBM intervention will be delivered. | Device: sham tDCS paired with sham MBM<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. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups. | day 3 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale (NRS) | The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). | day 3 after surgery | 
| Brief Pain Inventory (BPI) | It includes seven items and evaluates the impact of pain on general activity, mood, walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item represents a subscale and can be scored and analyzed individually (0-10), with the anchors being does not interfere (0) and completely interferes (10). A total interference score can also be calculated by taking the sum of all the items. | day 3 after surgery | 
| Patient Health Questionnaire-4 (PHQ-4) | with regards to emotional function, considering established relations between pain, anxiety, and depression, measures of anxiety and depression will be taken | day 3 after surgery | 
| Pain Catastrophizing Scale (PCS) | to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point scale with the end points not at all (score=0) and all the time (score=4). | day 3 after surgery | 
| Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system | 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 from baseline at day 5 of intervention | 
| Change in descending pain modulation (CPM) as measured by the quantitative sensory testing | Descending pain modulation will be determined by the change in pressure pain threshold on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold water bath at 12°C for one minute, with higher CPM scores indicating better descending pain modulation. Descending pain modulation will be reflected by an increase in pressure pain threshold after cold water immersion. | change from baseline at day 5 of intervention |