Mindfulness + tDCS for Osteoarthritis
(PROACT Trial)
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial does not specify that you must stop taking all current medications. However, if you are using opioids daily or certain medications like some sodium channel blockers, calcium channel blockers, and NMDA receptor antagonists, you may not be eligible to participate. Other medications will be recorded and considered in the analysis.
What data supports the idea that Mindfulness + tDCS for Osteoarthritis is an effective treatment?
The available research shows that combining mindfulness-based meditation (MBM) with transcranial direct current stimulation (tDCS) can effectively reduce pain in older adults with knee osteoarthritis. In a study with 30 participants, those who received the real treatment reported less pain and better knee function compared to those who received a fake version of the treatment. They also showed increased tolerance to pressure pain. Participants were satisfied with the treatment and experienced no serious side effects. This suggests that Mindfulness + tDCS is a promising option for managing osteoarthritis pain.12345
What safety data exists for combining mindfulness and tDCS for osteoarthritis?
The combination of transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) has been studied for its safety and efficacy in older adults with knee osteoarthritis. A pilot study found that participants tolerated the treatment well without serious adverse effects and were satisfied with the treatment. However, while tDCS is generally regarded as safe, there are warnings that it could potentially induce harmful conditions in healthy individuals. Therefore, caution is advised, and further research is needed to fully understand the safety profile of this combined treatment.14678
Is the treatment Mindfulness + tDCS promising for osteoarthritis?
Mindfulness + tDCS is a promising treatment for osteoarthritis because it combines mindfulness meditation, which can help reduce stress and improve focus, with transcranial direct current stimulation (tDCS), a technique that uses a small electrical current to potentially enhance brain function and reduce pain.910111213
What is the purpose of this trial?
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.
Research Team
Roger Fillingim
Principal Investigator
University of Florida
Eligibility Criteria
This trial is for African American or non-Hispanic white adults with knee osteoarthritis, as per the American College of Rheumatology criteria. Excluded are those with significant knee surgery history, uncontrolled hypertension, substance use disorders, daily opioid use, serious psychiatric conditions in the past year, other painful rheumatic diseases or fibromyalgia, and certain neurological conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Focused Breathing and Attention Training (BAT)
- Sham Transcranial Direct Current Stimulation (tDCS)
- Standard Breathing and Attention Training (BAT)
- Transcranial Direct Current Stimulation (tDCS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Institute on Aging (NIA)
Collaborator