317 Participants Needed

Mindfulness + tDCS for Osteoarthritis

(PROACT Trial)

Recruiting at 1 trial location
EW
MA
JS
Overseen ByJulie Siegrist
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

RF

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

You are of African American or non-Hispanic white ethnicity.
I have knee pain diagnosed as osteoarthritis by a doctor.

Exclusion Criteria

You have a severe mental illness that has required hospitalization in the past year or you currently have thoughts of hurting yourself.
I do not have high blood pressure or heart problems that limit my activities.
I am not taking certain medications that affect brain stimulation treatment.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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)
Trial Overview The PROACT study tests if mindfulness meditation training (MMT), Transcranial Direct Current Stimulation (tDCS), their combination or a sham procedure can improve pain management and brain function related to pain in people with knee osteoarthritis over five days.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Non-Hispanic White GroupExperimental Treatment4 Interventions
Non-Hispanic whites with knee osteoarthritis (OA).
Group II: African American GroupExperimental Treatment4 Interventions
African Americans with knee osteoarthritis (OA).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

A study involving 30 older adults with knee osteoarthritis showed that combining transcranial direct current stimulation (tDCS) with mindfulness-based meditation (MBM) significantly reduced pain and improved overall OA symptoms.
Participants tolerated the treatment well, reporting high satisfaction and no serious side effects, indicating that this combined approach is both safe and potentially effective for managing knee OA pain.
Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study.Ahn, H., Zhong, C., Miao, H., et al.[2020]
Transcranial direct current stimulation (tDCS) applied to the motor cortex significantly reduced pain severity in older adults with knee osteoarthritis, with effects lasting up to three weeks after treatment.
The study involved 40 participants aged 50 to 70, and tDCS was well-tolerated with no serious adverse effects or cognitive changes reported, indicating its safety for this population.
Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study.Ahn, H., Woods, AJ., Kunik, ME., et al.[2022]
This clinical trial aims to investigate the effectiveness of a combined mindfulness intervention (Breathing and Attention Training) and transcranial direct current stimulation (tDCS) in reducing knee osteoarthritis pain and improving function among non-Hispanic black and non-Hispanic white adults, addressing ethnic disparities in pain experiences.
Participants will undergo five treatment sessions over one week, with assessments of pain, function, and brain activity before and after treatment, making this the first study to explore the combined effects of mindfulness and tDCS on pain modulation across different ethnic groups.
Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.Fillingim, RB., Woods, AJ., Ahn, H., et al.[2021]

References

Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study. [2020]
Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study. [2022]
Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis. [2021]
Insights and Future Directions on the Combined Effects of Mind-Body Therapies with Transcranial Direct Current Stimulation: An Evidence-based Review. [2023]
Functional Near-Infrared Spectroscopy to Assess Central Pain Responses in a Nonpharmacologic Treatment Trial of Osteoarthritis. [2021]
Safety of transcranial direct current stimulation in healthy participants. [2021]
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]
Combining transcranial direct current stimulation with group cognitive behavioral therapy developed to treat rumination: a clinical pilot study. [2023]
Combining Deep Learning and Radiomics for Automated, Objective, Comprehensive Bone Mineral Density Assessment From Low-Dose Chest Computed Tomography. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Computed tomography for screening purposes: a review of the literature--2003. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Differential diagnosis of ground-glass opacity nodules: CT number analysis by three-dimensional computerized quantification. [2022]
Automatic opportunistic osteoporosis screening using low-dose chest computed tomography scans obtained for lung cancer screening. [2021]
Evaluation of fully automated commercial software for Agatston calcium scoring on non-ECG-gated low-dose chest CT with different slice thickness. [2023]
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