Trial Summary
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.
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.
12345What 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.
14678Is 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.
910111213Eligibility 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.
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Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Institute on Aging (NIA)Collaborator
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]Transcranial direct current stimulation (tDCS) has been shown to be effective for reducing pain, and a growing body of literature shows the potential analgesic effects of mindfulness-based meditation (MBM). However, few studies have investigated the potential benefits associated with combining tDCS and MBM in older adults with knee osteoarthritis (OA). Therefore, the aim of this study was to examine the feasibility and preliminary efficacy of home-based tDCS paired with MBM in older adults with knee OA. Thirty participants 50-85 years old with symptomatic knee OA were randomly assigned to receive 10 daily sessions of home-based 2 mA tDCS paired with active MBM for 20 min (n = 15) or sham tDCS paired with sham MBM (n = 15). We measured clinical pain and OA symptoms via a Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index. Pressure pain sensitivity and conditioned pain modulation were measured using quantitative sensory testing. Participant satisfaction and side effects were assessed via a questionnaire. Active tDCS paired with active MBM significantly reduced scores on the Numeric Rating Scale and Western Ontario and McMaster Universities Osteoarthritis Index and increased pressure pain thresholds and conditioned pain modulation. Participants tolerated tDCS paired with MBM well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising clinical efficacy of home-based tDCS paired with MBM for older adults with knee OA.
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]Previous studies indicate that transcranial direct current stimulation (tDCS) with anode over motor cortex (M1) and cathode over contralateral supraorbital region (SO) may be effective in reducing pain, but these studies are limited in number and have not focused on older adults with osteoarthritis (OA).
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]Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance and pain-related brain function, reduce clinical pain, and attenuate ethnic differences therein, among NHBs and NHWs with knee OA. Participants will complete assessments of clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation. Neuroimaging will be performed to examine pain-related brain structure and function. Then, participants will be randomized to one of four groups created by crossing two BAT conditions (Real vs. Sham) with two tDCS conditions (Real vs. Sham). Participants will then undergo five treatment sessions during which the assigned BAT and tDCS interventions will be delivered concurrently for 20 min over one week. After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months. This will be the first study to determine whether mindfulness and tDCS treatments will show additive or synergistic effects when combined, and whether treatment effects differ across ethnic/race groups.
Insights and Future Directions on the Combined Effects of Mind-Body Therapies with Transcranial Direct Current Stimulation: An Evidence-based Review. [2023]Mind-body therapies (MBTs) use mental abilities to modify electrical neural activity across brain networks. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates neuronal membrane potentials to enhance neuroplasticity. A combination of these treatment strategies may generate synergistic or additive effects, and thus has been more commonly tested in clinical trials, fostering a novel yet promising field of research. We conducted a literature search in four different databases including only randomized clinical trials (RCTs) that tested the combination of MBTs with tDCS. Ten studies (n=461) were included. Combined protocols included meditation/mindfulness (8/10), biofeedback (1/10), and hypnosis (1/10). The RCTs were heterogeneous with regards to population, design, and types of outcomes. Based on the findings of this search, we provide here a content description, methodological and practical insights, and future directions for the field. We hope this review will provide future authors with information to facilitate the development of trials with improved protocols.
Functional Near-Infrared Spectroscopy to Assess Central Pain Responses in a Nonpharmacologic Treatment Trial of Osteoarthritis. [2021]Knee osteoarthritis (OA) is a common source of pain in older adults. Although OA-induced pain can be relieved with analgesics and anti-inflammatory drugs, the current opioid epidemic is fostering the exploration of nonpharmacologic strategies for pain mitigation. Amongs these, transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) hold potential for pain-relief efficacy due to their neuromodulatory effects of the central nervous system, which is known to play a fundamental role in pain perception and processing.
Safety of transcranial direct current stimulation in healthy participants. [2021]•Transcranial Direct Current Stimulation (tDCS) is mostly reported as safe.•BUT it could induce life-changing conditions in healthy volunteers.•Scientific community MUST be warned that tDCS may be harmful and protect healthy volunteers.
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]Transcranial direct current stimulation (tDCS) is an in-demand form of neuromodulation generally regarded as safe and well tolerated. However, few studies have examined the safety, tolerability, or blinding of High Definition (HD-) tDCS, especially in older adults and at stimulation intensities of 2 milliamps (mA) or greater.
Combining transcranial direct current stimulation with group cognitive behavioral therapy developed to treat rumination: a clinical pilot study. [2023]As part of repetitive negative thinking (RNT), rumination is a maladaptive cognitive response style to stress or negative mood which can increase the risk of depression and may prohibit complete recovery. Cognitive behavioral therapy (CBT) and transcranial direct current stimulation (tDCS) both proved to be effective in decreasing rumination. However, the combined effects of tDCS and CBT interventions on rumination have not yet been explored. The first aim of this pilot study is to investigate whether the combination of tDCS and CBT has an accumulating positive effect on modulating state rumination. The second aim is to assess the feasibility and safety profile of the proposed combined approach.
Combining Deep Learning and Radiomics for Automated, Objective, Comprehensive Bone Mineral Density Assessment From Low-Dose Chest Computed Tomography. [2023]To develop an intelligent diagnostic model for osteoporosis screening based on low-dose chest computed tomography (LDCT). The model incorporates automatic deep-learning thoracic vertebrae of cancellous bone (TVCB) segmentation model and radiomics analysis.
Computed tomography for screening purposes: a review of the literature--2003. [2016]This paper reviews the scientific literature on four procedures: Coronary Calcium Scoring (CCS), Lung Cancer Screening (LCS), Computed Tomographic Colonography (CTC), and Whole Body Computed Tomography (WBCT). No published studies demonstrate that these procedures reduce morbidity or mortality when used to screen healthy, asymptomatic patients.
Differential diagnosis of ground-glass opacity nodules: CT number analysis by three-dimensional computerized quantification. [2022]To differentiate among atypical adenomatous hyperplasia (AAH), bronchioloalveolar carcinoma (BAC), and adenocarcinoma showing ground-glass opacity (GGO) on CT scans, we conducted a study to determine the optimal parameter on CT number analysis using three-dimensional (3D) computerized quantification.
Automatic opportunistic osteoporosis screening using low-dose chest computed tomography scans obtained for lung cancer screening. [2021]Osteoporosis is a prevalent and treatable condition, but it remains underdiagnosed. In this study, a deep learning-based system was developed to automatically measure bone mineral density (BMD) for opportunistic osteoporosis screening using low-dose chest computed tomography (LDCT) scans obtained for lung cancer screening.
Evaluation of fully automated commercial software for Agatston calcium scoring on non-ECG-gated low-dose chest CT with different slice thickness. [2023]To evaluate commercial deep learning-based software for fully automated coronary artery calcium (CAC) scoring on non-electrocardiogram (ECG)-gated low-dose CT (LDCT) with different slice thicknesses compared with manual ECG-gated calcium-scoring CT (CSCT).