Pain relief for knee osteoarthritis using mindfulness and brain stimulation
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
This study is testing whether a five-day program of mindfulness meditation and brain stimulation can help people with knee osteoarthritis manage their pain better, especially focusing on African Americans and non-Hispanic whites.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT03884374 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests the effectiveness of a five-day course of mindfulness meditation training and transcranial direct current stimulation (tDCS) to improve pain management in individuals with knee osteoarthritis. The study aims to enhance pain modulatory balance and brain function related to pain, specifically focusing on African Americans and non-Hispanic whites. By combining these interventions, the trial seeks to provide evidence that addressing stress and pain-related brain function can reduce pain and disparities in pain experiences among different ethnic groups.
Who should consider this trial
Good fit: Ideal candidates are individuals with unilateral or bilateral symptomatic knee osteoarthritis who identify as either African American or non-Hispanic white.
Not a fit: Patients with systemic rheumatic diseases, significant knee surgery history, or those using opioids daily may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve quality of life for patients with knee osteoarthritis.
How similar studies have performed: While this approach combines established techniques, the specific combination of mindfulness meditation and tDCS for knee osteoarthritis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Roger Fillingim — University of Florida
- Study coordinator: Eric Weber
- Email: eweber@dental.ufl.edu
- Phone: 352-273-7802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.