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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
317
Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
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.
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
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Florida
Gainesville, Florida, United States
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 26 question index to assess knee OA pain (0-20 scale), function (0-68 scale), and stiffness (0-8 scale). The total WOAMC score is the sum of the 3 sub scales for a total score range from 0-96. Change in total WOMAC score = V7 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness.
Time frame: Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.
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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.