Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

Study Overview
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Brief Summary
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This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein.

Official Title
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Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

Conditions
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Osteoarthritis of Knee

Intervention / Treatment
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* Behavioral: Focused Breathing and Attention Training (BAT)
* Behavioral: Standard Breathing and Attention Training (BAT)
* Device: Transcranial Direct Current Stimulation (tDCS)
* Device: Sham Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral symptomatic knee OA based on American College of Rheumatology Clinical criteria Participant reports primary ethnic/race group as either African American or non-Hispanic white Exclusion Criteria: Actively symptomatic systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus), or fibromyalgia that results in pain outside the knee that is equal to or worse than the participant's knee pain. A history of clinically significant surgery to the index knee. Daily use of opioids. We will exclude patients using opioids daily as both continued use and temporary withdrawal from these medications this could affect pain perception and response to interventions. Other medications being used will be recorded and controlled in statistical analyses as needed. Use of some centrally acting sodium channel blockers, calcium channel blockers and NMDA receptor antagonists, because some of these medications can block tDCS effects. Other medications can potentially influence response to tDCS (e.g. SSRIs, beta-blockers); therefore, consistent with recent recommendations (2), we will assess use of these medications and include them as covariates in our statistical models. Uncontrolled hypertension (i.e. SBP/DBP of > 150/95) or unstable or activity limiting cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons, because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals. Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy) or evidence of previous brain injury, including stroke and traumatic brain injury. Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation. Current substance use disorder or history of hospitalization for treatment of substance use disorder. Diminished cognitive function that would interfere with understanding of study procedures.

Ages Eligible for Study
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Minimum Age: 45 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: Factorial Assignment
Interventional Model Description: Adults (half AA, half NHW) with knee OA will be randomized to one of four conditions created by crossing Real tDCS vs. Sham tDCS with Focused BAT vs. Standard BAT
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: African American Group<br>African Americans with knee osteoarthritis (OA). | Behavioral: Focused Breathing and Attention Training (BAT)<br>* Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.<br>Behavioral: Standard Breathing and Attention Training (BAT)<br>* Standard BAT intervention will incorporate most of the general aspects of the Focused BAT intervention but without the specific instructions related to mindfully attending to the breath in a non-evaluative manner.<br>Device: Transcranial Direct Current Stimulation (tDCS)<br>* A Soterix 1x1 Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two bicarbon rubber electrodes encased in saline-soaked sponges<br>* Other names: Soterix 1x1 Clinical Trials Direct Current Stimulator;Device: Sham Transcranial Direct Current Stimulation (tDCS)<br>* Sham stimulation procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA (30s ramp up/down) of stimulation at the beginning of the session.<br>|
| Experimental: Non-Hispanic White Group<br>Non-Hispanic whites with knee osteoarthritis (OA). | Behavioral: Focused Breathing and Attention Training (BAT)<br>* Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.<br>Behavioral: Standard Breathing and Attention Training (BAT)<br>* Standard BAT intervention will incorporate most of the general aspects of the Focused BAT intervention but without the specific instructions related to mindfully attending to the breath in a non-evaluative manner.<br>Device: Transcranial Direct Current Stimulation (tDCS)<br>* A Soterix 1x1 Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two bicarbon rubber electrodes encased in saline-soaked sponges<br>* Other names: Soterix 1x1 Clinical Trials Direct Current Stimulator;Device: Sham Transcranial Direct Current Stimulation (tDCS)<br>* Sham stimulation procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA (30s ramp up/down) of stimulation at the beginning of the session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | 26 question index to assess knee OA pain; ranked from 'no pain' to 'extreme pain' | Baseline; Day 1; Day 2; Day 3; Day 4; Day 5 |