Mindfulness + tDCS for Osteoarthritis

(PROACT Trial)

No longer 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

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

Who 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

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 for a Trial Participant

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

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)

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.

How Is the Trial Designed?

Group I: Sham/Sham Experimental Treatment 2 Interventions

Standard Breathing and Attention Training (BAT): Standard BAT intervention will incorporate most of the general aspects of the Focused BAT intervention but without the specific instructions related to mindfully attending to the breath in a non-evaluative manner. Sham Transcranial Direct Current Stimulation (tDCS): Sham stimulation procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA (30s ramp up/down) of stimulation at the beginning of the session.

Group II: Sham/Active Experimental Treatment 2 Interventions

Standard Breathing and Attention Training (BAT): Standard BAT intervention will incorporate most of the general aspects of the Focused BAT intervention but without the specific instructions related to mindfully attending to the breath in a non-evaluative manner. Transcranial Direct Current Stimulation (tDCS): A Soterix 1x1 Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two bicarbon rubber electrodes encased in saline-soaked sponges

Group III: Active/Sham Experimental Treatment 2 Interventions

Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation. Sham Transcranial Direct Current Stimulation (tDCS): Sham stimulation procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA (30s ramp up/down) of stimulation at the beginning of the session.

Group IV: Active/Active Experimental Treatment 2 Interventions

Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation. Transcranial Direct Current Stimulation (tDCS): A Soterix 1x1 Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two bicarbon rubber electrodes encased in saline-soaked sponges

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9150306/

Evaluation of mindfulness based stress reduction in ...

Our pilot RCT found encouraging results with a delayed but long-term efficacy in pain VAS following a MBSR program in symptomatic knee or hip OA ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11254171/

Telehealth mindful exercise for people with knee ...

At 8-weeks, mindful exercise and exercise groups had retention rates of 86% (18/21) and 100% (19/19), and attendance was 54% (11.4/21) and 68% ( ...

3.

frontiersin.org

frontiersin.org/journals/pain-research/articles/10.3389/fpain.2023.1271839/full

Self-regulation training for people with knee osteoarthritis

Self-regulation training targeting normalising brain functioning related to pain experience could improve clinical outcomes (18–24). Mindfulness meditation ...

4.

researchgate.net

researchgate.net/publication/360959408_Evaluation_of_mindfulness_based_stress_reduction_in_symptomatic_knee_or_hip_osteoarthritis_patients_a_pilot_randomized_controlled_trial

(PDF) Evaluation of mindfulness based stress reduction in ...

Background: To evaluate the efficacy for symptomatic knee and hip osteoarthritis (OA) patients of a mindfulness‑. based stress reduction ...

5.

jhwcr.com

jhwcr.com/index.php/jhwcr/article/viewFile/646/545

Comparison of Mindfulness Meditation-Based Exercise vs. ...

Conclusion: MME is more effective than ST in improving pain, mobility, and quality of life in patients with knee OA, supporting its integration ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03884374

Pain Relief for OsteoArthritis Through Combined Treatment ...

Focused Breathing and Attention Training (BAT): Participants will receive mindfulness-based mental training regimen to independently practice mindfulness ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7686081/

Pain Relief for OsteoArthritis through Combined Treatment ...

Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis: A ...

8.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/40/NCT03747640/Prot_SAP_000.pdf

Self Transcranial Direct Current Stimulation and ...

The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation on pain using ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9557732/

Non-invasive brain stimulation for osteoarthritis - PMC

This paper describes the therapeutic effects and possible mechanisms of six commonly used NIBS methods in OA, namely single pulse transcranial ...

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S1697260023000054

Stimulated brains and meditative minds: A systematic ...

Low intensity transcranial electrical stimulation (tES) and meditation are two promising, yet variable, non-pharmacological interventions.