CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 317 enrolled
Drug / intervention
Focused Breathing and Attention Training (BAT) +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03884374
NCT03884374N/ACompleted

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

University of Florida·interventional·Posted Mar 21, 2019·Updated Aug 15, 2025

In Brief

A clinical study evaluating Focused Breathing and Attention Training (BAT), Standard Breathing and Attention Training (BAT), and 2 other interventions for Osteoarthritis of Knee. Completed, enrolled 317 participants across 2 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartMar 13, 2020
Primary CompletionFeb 28, 2025
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.3 years ago

Interventions

Focused Breathing and Attention Training (BAT)behavioral

Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.

Standard Breathing and Attention Training (BAT)behavioral

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.

Transcranial Direct Current Stimulation (tDCS)device

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

Sham Transcranial Direct Current Stimulation (tDCS)device

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.