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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis of Knee
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sham/Sham; 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. 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.	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: 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.
Experimental: Sham/Active; 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. 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	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; Other Names: Soterix 1x1 Clinical Trials Direct Current Stimulator
Experimental: Active/Sham; Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation. 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.	Behavioral: Focused Breathing and Attention Training (BAT); Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.; 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.
Experimental: Active/Active; Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation. 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	Behavioral: Focused Breathing and Attention Training (BAT); Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.; 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; Other Names: Soterix 1x1 Clinical Trials Direct Current Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Roger Fillingim, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRB201900232 -N; R37AG033906 (U.S. NIH Grant/Contract); OCR20408 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No