tDCS + Mindfulness Meditation for Osteoarthritis

No longer recruiting at 2 trial locations

Overseen By Hyochol Ahn, PhD,RN,MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Brain surgery, Rheumatic disorders, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how combining a brain stimulation technique called transcranial direct current stimulation (tDCS) with mindfulness meditation might relieve knee pain from osteoarthritis. Researchers aim to determine how effectively these treatments work together in reducing pain and improving overall satisfaction among participants. The trial includes different groups to test the effects of both active and sham versions of tDCS and mindfulness meditation. It suits individuals who have experienced knee osteoarthritis pain for the past three months and do not plan to change their pain medication during the trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial requires that you do not change your current medication regimen for pain throughout the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a gentle electrical treatment called transcranial direct current stimulation (tDCS) with mindfulness-based meditation (MBM) is generally safe and well-tolerated for people with knee osteoarthritis. Studies have found that applying 2 mA of tDCS for 20 minutes is safe for older adults, even those with long-term knee pain. Most participants in these studies experienced no major issues with the treatment.

When used alone, tDCS significantly reduced pain compared to a placebo version, indicating its effectiveness without harmful side effects.

For those practicing MBM without real tDCS, no specific safety concerns have been noted. However, combining tDCS with MBM has shown promising results for pain relief. Overall, this combination therapy has been well-received by participants and has demonstrated potential benefits without causing significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for osteoarthritis because they combine transcranial direct current stimulation (tDCS) with mindfulness meditation, offering a novel approach compared to traditional pain management techniques like NSAIDs or physical therapy. tDCS is a non-invasive brain stimulation method that can modulate pain perception by delivering a low electrical current to the brain, potentially reducing pain without the side effects of medication. Mindfulness meditation, on the other hand, is known to help manage pain by promoting relaxation and changing the way individuals perceive pain. By pairing these two methods, the trial aims to explore how they might work together to provide relief, offering a promising, drug-free alternative for osteoarthritis sufferers.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research has shown that using a gentle electrical treatment called transcranial direct current stimulation (tDCS) along with mindfulness-based meditation (MBM) can help with knee osteoarthritis (OA). In this trial, participants may receive active tDCS paired with active MBM, which has helped older adults with knee OA feel less pain and improve their symptoms. Participants appreciated the treatment and did not experience any serious side effects. Another arm of the trial involves active tDCS paired with sham MBM, which also reduced pain more than a fake (inactive) version. These results suggest that both the combination of tDCS and MBM, as well as tDCS alone, could effectively manage knee OA pain. ^{2 5 6 7 8}

Who Is on the Research Team?

Hyochol Ahn, PhD,RN,MSN

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with knee pain from osteoarthritis, who've had an average pain score of at least 30 out of 100 in the past three months. Participants should not plan to change their pain medication during the study and must have access to videoconferencing tools.

Inclusion Criteria

Have no plan to change medication regimens for pain throughout the trial

Can speak and read English

I have knee pain diagnosed as osteoarthritis.

Exclusion Criteria

Alcohol/substance abuse

I have a condition like rheumatoid arthritis, lupus, or fibromyalgia.

I have a history of brain surgery, tumor, seizure, stroke, or metal in my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) or sham interventions for knee osteoarthritis

2 weeks

5 times a week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mindfulness, pain intensity, and osteoarthritis symptoms

3 months

3 follow-up assessments (months 1, 2, and 3 post-intervention)

What Are the Treatments Tested in This Trial?

Interventions

• active tDCS paired with active MBM
• active tDCS paired with sham MBM
• sham tDCS paired with active MBM
• sham tDCS paired with sham MBM

Trial Overview The study tests if a combination of active transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) can reduce knee pain and improve symptoms in osteoarthritis patients compared to placebo treatments.

How Is the Trial Designed?

Group I: active tDCS paired with active MBM, Experimental Treatment 1 Intervention

Group II: active tDCS paired with sham MBM Active Control 1 Intervention

Group III: sham tDCS paired with active MBM Active Control 1 Intervention

Group IV: sham tDCS paired with sham MBM Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

In a study involving 40 older adults with knee osteoarthritis, transcranial direct current stimulation (tDCS) significantly increased pain thresholds and tolerances, indicating its efficacy in reducing experimental pain sensitivity.

The improvements in experimental pain measures from tDCS were linked to reductions in clinical pain, suggesting that tDCS could be a promising non-invasive treatment for managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bayesian analysis of the effect of transcranial direct current stimulation on experimental pain sensitivity in older adults with knee osteoarthritis: randomized sham-controlled pilot clinical study. Ahn, H., Suchting, R., Woods, AJ., et al.[2022]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

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]

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]

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]

The study involved 30 participants with knee osteoarthritis who received either active transcranial direct current stimulation (tDCS) combined with exercise or a sham treatment for 8 weeks, showing that adding tDCS is safe and feasible.

While both groups experienced pain reduction, only the active tDCS group showed significant improvements in function and pressure pain thresholds, suggesting that tDCS may enhance the benefits of exercise in managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. Chang, WJ., Bennell, KL., Hodges, PW., 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31421990/

Efficacy of combining home-based transcranial direct ... Our findings demonstrate promising clinical efficacy of home-based tDCS paired with MBM for older adults with knee OA.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03747640

Study Details | NCT03747640 | Self Transcranial Direct ... The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0987705323000758

Efficacy of transcranial direct current stimulation in patients ... This review focuses on the application of tDCS as a therapeutic intervention for managing knee osteoarthritis (OA), a prevalent musculoskeletal condition.

4. trialx.com trialx.com/clinical-trials/listings/219435/home-based-tdcs-and-mindfulness-based-meditation-for-self-management-of-clinical-pain-and-symptoms/?&radius=50

Home-based tDCS and Mindfulness-based Meditation for ... The purpose of this study is to determine the effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness- ...

5. researchgate.net researchgate.net/publication/335183338_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

Efficacy of combining home-based transcranial direct current ... Participants tolerated tDCS paired with MBM well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03747640

Study Details | NCT03747640 | Self Transcranial Direct ... The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21000462

Motor cortex transcranial direct current stimulation effects ... 2 mA for 20 min of anodal tDCS is safe and well tolerated in the elderly. •. tDCS alone did not induce long-term effects in the elderly with knee chronic pain.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06228573

Transcranial Direct Current Stimulation and Yoga for Knee ... Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis ...