Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

NCT03884374 | Completed Results FDA Device

• 3 other identifiers: IRB201900232 -NR37AG033906OCR20408
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Sham/Sham

EXPERIMENTAL

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); Device: Sham Transcranial Direct Current Stimulation (tDCS)

Sham/Active

EXPERIMENTAL

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); Device: Transcranial Direct Current Stimulation (tDCS)

Active/Sham

EXPERIMENTAL

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); Device: Sham Transcranial Direct Current Stimulation (tDCS)

Active/Active

EXPERIMENTAL

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); Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Focused Breathing and Attention Training (BAT) BEHAVIORAL

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

Active/Active; Active/Sham

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.

Sham/Active; Sham/Sham

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

Also known as: Soterix 1x1 Clinical Trials Direct Current Stimulator

Active/Active; Sham/Active

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.

Active/Sham; Sham/Sham

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Eric Weber
• Organization: University of Florida

ebweber@ufl.edu

352-273-7802

Study Officials

• Roger Fillingim

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be block randomized with stratification for site, sex, and race in double blind fashion.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: March 13, 2020
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)