Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)

NCT ID: NCT03884374

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 317 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-13
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard Breathing and Attention Training (BAT)

Intervention Type: 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 Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Standard Breathing and Attention Training (BAT)

Intervention Type: 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)

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Focused Breathing and Attention Training (BAT)

Intervention Type: BEHAVIORAL

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

Sham Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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/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

Group Type: EXPERIMENTAL

Focused Breathing and Attention Training (BAT)

Intervention Type: BEHAVIORAL

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

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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

Interventions

Focused Breathing and Attention Training (BAT)

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Soterix 1x1 Clinical Trials Direct Current Stimulator

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Fillingim

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Florida

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R37AG033906

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR20408

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201900232 -N

Identifier Type: -

Identifier Source: org_study_id