Mindfulness + tDCS for Osteoarthritis

(PROACT Trial)

Recruiting at 1 trial location

Overseen By Julie Siegrist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Opioids, Sodium blockers, Calcium blockers, NMDA antagonists

Disqualifiers: Rheumatoid arthritis, Fibromyalgia, Uncontrolled hypertension, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

317 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{9 10 11 12 13}

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

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.

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

Group I: Non-Hispanic White Group Experimental Treatment 4 Interventions

Non-Hispanic whites with knee osteoarthritis (OA).

Group II: African American Group Experimental Treatment 4 Interventions

African Americans with knee osteoarthritis (OA).

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The review analyzed 10 randomized clinical trials involving 461 participants that combined mind-body therapies (like meditation and mindfulness) with transcranial direct current stimulation (tDCS), a technique that enhances brain activity and neuroplasticity.

The combination of MBTs and tDCS shows promise for improving treatment outcomes, but the studies varied widely in design and population, indicating a need for more standardized protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights and Future Directions on the Combined Effects of Mind-Body Therapies with Transcranial Direct Current Stimulation: An Evidence-based Review. Rebello-Sanchez, I., Vasquez-Avila, K., Parente, J., et al.[2023]

In a double-blind study involving 19 older adults with knee osteoarthritis, the combination of transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) significantly relieved pain compared to a sham treatment.

The active treatment group showed increased oxyhemoglobin activation in brain areas related to pain processing, indicating that tDCS and MBM may effectively modulate pain perception through neural mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Near-Infrared Spectroscopy to Assess Central Pain Responses in a Nonpharmacologic Treatment Trial of Osteoarthritis. Pollonini, L., Montero-Hernandez, S., Park, L., et al.[2021]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

The pilot study involving 17 adults with repetitive negative thinking (RNT) found that combining transcranial direct current stimulation (tDCS) with cognitive behavioral therapy (CBT) was safe and feasible, but did not show significant additional benefits in reducing state rumination compared to CBT alone.

Despite the lack of significant results, the study suggests that future research with larger sample sizes and refined methodologies could explore the potential of tDCS combined with CBT to effectively address rumination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining transcranial direct current stimulation with group cognitive behavioral therapy developed to treat rumination: a clinical pilot study. Horczak, P., Wang, C., De Witte, S., et al.[2023]

A new intelligent diagnostic model for osteoporosis screening using low-dose chest CT (LDCT) has been developed, which includes an automatic deep-learning segmentation of thoracic vertebrae and radiomics analysis, tested on 442 participants.

The model demonstrated high accuracy in segmenting vertebrae and predicting bone mineral density (BMD), with comparable performance between automatic and manual segmentation methods, indicating its potential for effective opportunistic BMD screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Deep Learning and Radiomics for Automated, Objective, Comprehensive Bone Mineral Density Assessment From Low-Dose Chest Computed Tomography. Wang, S., Tong, X., Fan, Y., et al.[2023]

A review of scientific literature on four screening procedures—Coronary Calcium Scoring, Lung Cancer Screening, Computed Tomographic Colonography, and Whole Body Computed Tomography—found no evidence that these methods reduce illness or death in healthy, asymptomatic individuals.

The lack of published studies supporting the effectiveness of these screening procedures raises questions about their utility in preventive healthcare for asymptomatic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography for screening purposes: a review of the literature--2003. Dixon, GD.[2016]

The study analyzed CT numbers from ground-glass opacity lesions in 43 patients (10 with atypical adenomatous hyperplasia, 21 with bronchioloalveolar carcinoma, and 12 with adenocarcinoma) to differentiate between these conditions using 3D computerized quantification.

Key findings include that a CT number histogram showing two peaks can effectively rule out atypical adenomatous hyperplasia, while specific CT number cutoffs can differentiate between bronchioloalveolar carcinoma and adenocarcinoma, enhancing diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential diagnosis of ground-glass opacity nodules: CT number analysis by three-dimensional computerized quantification. Ikeda, K., Awai, K., Mori, T., et al.[2022]

A deep learning-based system was successfully developed to automatically measure bone mineral density (BMD) using low-dose chest CT scans, achieving high accuracy with a mean Dice coefficient of 86.6% for vertebral body segmentation and 97.5% for labeling.

The system demonstrated excellent diagnostic performance for osteoporosis screening, with an area under the curve (AUC) of 0.927 for detecting osteoporosis and 0.942 for identifying low BMD, indicating its potential as a valuable tool for opportunistic screening in lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic opportunistic osteoporosis screening using low-dose chest computed tomography scans obtained for lung cancer screening. Pan, Y., Shi, D., Wang, H., et al.[2021]

Automated coronary artery calcium (CAC) scoring using low-dose CT (LDCT) with a 1.0-mm slice thickness showed excellent agreement with manual scoring, indicating high reliability and accuracy in assessing coronary artery health.

The study found that LDCT with a 1.0-mm slice thickness outperformed 2.5-mm slice thickness in diagnostic performance for detecting high Agatston scores, suggesting that thinner slices may provide better results in automated CAC scoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of fully automated commercial software for Agatston calcium scoring on non-ECG-gated low-dose chest CT with different slice thickness. Kang, HW., Ahn, WJ., Jeong, JH., et al.[2023]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Insights and Future Directions on the Combined Effects of Mind-Body Therapies with Transcranial Direct Current Stimulation: An Evidence-based Review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Functional Near-Infrared Spectroscopy to Assess Central Pain Responses in a Nonpharmacologic Treatment Trial of Osteoarthritis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Combining transcranial direct current stimulation with group cognitive behavioral therapy developed to treat rumination: a clinical pilot study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Combining Deep Learning and Radiomics for Automated, Objective, Comprehensive Bone Mineral Density Assessment From Low-Dose Chest Computed Tomography. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Computed tomography for screening purposes: a review of the literature--2003. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Differential diagnosis of ground-glass opacity nodules: CT number analysis by three-dimensional computerized quantification. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Automatic opportunistic osteoporosis screening using low-dose chest computed tomography scans obtained for lung cancer screening. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of fully automated commercial software for Agatston calcium scoring on non-ECG-gated low-dose chest CT with different slice thickness. [2023]