MedTrace Logo

Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

NCT03884374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2025-08-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Osteoarthritis of Knee

Interventions

BEHAVIORAL

Focused Breathing and Attention Training (BAT)

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

BEHAVIORAL

Standard Breathing and Attention Training (BAT)

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.

DEVICE

Transcranial Direct Current Stimulation (tDCS)

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

DEVICE

Sham Transcranial Direct Current Stimulation (tDCS)

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Roger Fillingim · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2025-02-28
Completion
2025-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884374 on ClinicalTrials.gov