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OpenTrials
Completed

NCT Number: NCT03884374

Pain Relief for OsteoArthritis Through Combined Treatment (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.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Soterix 1x1 Clinical Trials Direct Current Stimulator

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.

Primary outcomes

  1. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    Time frame: Visit 1-Baseline prior to intervention and Visit 7 which is about 1 month after baseline visit and study intervention.

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: PROACT

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2019
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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