Mindfulness + tDCS for Osteoarthritis
(PROACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the effectiveness of mindfulness meditation and transcranial direct current stimulation (tDCS) in reducing knee osteoarthritis pain. Researchers will divide participants into groups to test various combinations of mindfulness training and tDCS. The trial seeks participants who have experienced knee osteoarthritis pain and are either African American or non-Hispanic white. The goal is to determine if these treatments can enhance pain management and address differences in pain experiences between groups. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to improved pain management strategies.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mindfulness meditation training (MMT) and transcranial direct current stimulation (tDCS) have been explored for pain relief in people with osteoarthritis. tDCS involves applying a low electrical current to the brain, which might help with pain. Focused Breathing and Attention Training (BAT) uses mindfulness techniques that could also reduce pain.
Studies indicate that these treatments are generally well-tolerated. Some people might feel a slight tingling or itching on the skin where tDCS electrodes are placed, but serious side effects are rare. Mindfulness practices like BAT are usually safe, with no major negative effects reported.
Anyone considering joining the trial should know these treatments have been shown to be safe in past research. However, if there are concerns or questions, consulting a healthcare provider is always a good idea.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they combine mindfulness techniques with transcranial direct current stimulation (tDCS), offering a non-invasive approach to managing osteoarthritis pain. Unlike standard treatments like NSAIDs or opioids, which primarily address pain through chemical means, this approach aims to harness the power of the mind and electrical stimulation. Mindfulness-based Breathing and Attention Training (BAT) helps patients engage in mental exercises for pain relief, while tDCS uses mild electrical currents to potentially enhance brain function and reduce pain perception. This combination could provide a new avenue for pain management without the side effects commonly associated with medication.
What evidence suggests that this trial's treatments could be effective for osteoarthritis?
Research has shown that mindfulness meditation can reduce pain and improve the quality of life for people with knee osteoarthritis (OA). One study found that exercises based on mindfulness meditation were more effective than standard treatments in improving pain and mobility for knee OA patients. In this trial, some participants will receive Focused Breathing and Attention Training (BAT) as part of their mindfulness training.
Transcranial direct current stimulation (tDCS) has also shown promise. A review of several studies found that tDCS significantly reduced pain compared to a fake (sham) version of the treatment in knee OA patients. In this trial, participants will be assigned to different arms to receive either active or sham tDCS. These findings suggest that both mindfulness training and tDCS, as studied in this trial, might help manage knee OA pain.678910Who Is on the Research Team?
Roger Fillingim
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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