Brain Stimulation + Yoga for Osteoarthritis

Recruiting at 2 trial locations

Overseen By Guillaume Leonard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Systemic inflammatory arthritis, Neurological conditions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 9 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage knee osteoarthritis pain by combining Transcranial Direct Current Stimulation (tDCS) with yoga, also known as the Mindfulness Program, Meditation Program, or Yoga Therapy. The goal is to reduce pain by altering brain perception and enhancing overall well-being through yoga. Participants will receive either real or sham tDCS along with yoga to evaluate the effectiveness of this approach. Suitable candidates include those diagnosed with knee osteoarthritis or experiencing movement-related joint pain with minimal morning stiffness, and who have had moderate pain in the past month. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques and contribute to advancing treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those currently receiving care for knee osteoarthritis pain, such as physiotherapy.

What prior data suggests that this brain stimulation technique and yoga combination is safe for managing knee arthritis pain?

Research has shown that transcranial Direct Current Stimulation (tDCS) is generally safe and well-tolerated. One study found that using a low electrical current for 20 minutes is safe for older adults, even those with knee pain. Another study demonstrated that adding tDCS to exercise for knee arthritis did not cause any safety issues. Additionally, tDCS can help reduce short-term pain without major side effects.

Yoga, the other part of this treatment, is a well-known practice focused on well-being and is considered safe for most people. Combining these two methods aims to improve pain management without serious risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines brain stimulation with yoga to manage osteoarthritis pain, offering a unique approach compared to traditional treatments like NSAIDs and physical therapy. The active transcranial Direct Current Stimulation (tDCS) targets the primary motor cortex, potentially enhancing brain activity to reduce pain, while yoga adds a holistic component that promotes flexibility and strength. This combination could offer a non-invasive, drug-free alternative that enhances quality of life for osteoarthritis patients.

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

Research shows that Transcranial Direct Current Stimulation (tDCS) can help reduce pain in people with knee osteoarthritis. A review of several studies found that tDCS significantly lowered pain compared to a sham version of the treatment. In this trial, participants will join either an Active tDCS arm or a Sham tDCS arm to evaluate the treatment's effectiveness.

Regarding yoga, studies have shown it effectively reduces pain and stiffness in people with knee osteoarthritis. It also improves physical function, making movement easier. This trial will combine yoga with either active or sham tDCS, potentially offering a new way to manage knee arthritis pain effectively. ^{2 4 6 7 8}

Who Is on the Research Team?

Lisa Carlesso, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis who often deal with persistent pain and are looking for new ways to manage it. The study is open to those willing to try a combination of brain stimulation and yoga, but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Community dwelling adults from Sherbrooke, Quebec, Hamilton and London, Ontario fulfilling the NICE criteria for KOA

I am 45 years old or older.

I have knee pain from arthritis or joint pain with little to no morning stiffness and it's been a 3/10 or more in the last month.

Exclusion Criteria

Planned absences > 1 week

Metallic implants

A cochlear or ocular implant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcranial Direct Current Stimulation (tDCS) combined with yoga sessions

9 weeks

5 visits (in-person) in Week 1, weekly sessions from Weeks 2 to 9

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Yoga

Trial Overview

The trial tests a novel approach combining Transcranial Direct Current Stimulation (tDCS), which alters brain activity to reduce pain, with yoga that promotes overall well-being. Participants will be randomly assigned to receive either real tDCS or sham tDCS along with yoga sessions.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Active tDCS Arm: In Week 1, participants in the Active tDCS arm will undergo five in-person visits for the administration of active transcranial Direct Current Stimulation (tDCS). Subsequently, from Weeks 2 to 9, participants will receive weekly active tDCS sessions preceding the scheduled yoga sessions. For the active tDCS sessions, a constant current stimulator will be employed to deliver direct current through a pair of surface sponge electrodes (5×7 cm) soaked in saline. Participants will undergo anodal stimulation targeting the primary motor cortex (M1) contralateral to the most painful site (C3 or C4 based on the electroencephalogram 10/20 system). The cathodal electrode will be positioned on the supraorbital area contralateral to the anode. During active tDCS, a constant anodal current of 2 mA will be administered for 20 minutes, a duration known to enhance cortical excitability and alleviate pain. T

Group II: Sham tDCS Placebo Group 1 Intervention

Sham tDCS Arm: tDCS: In Week 1, participants in the Sham tDCS arm will attend five in-person visits for the administration of sham transcranial Direct Current Stimulation (tDCS). From Weeks 2 to 9, participants will receive weekly sham tDCS sessions before the scheduled yoga sessions. Constant current stimulator will be used to deliver direct current through a pair of surface sponge electrodes (5×7 cm) soaked in saline. Participants will undergo sham stimulation targeting the primary motor cortex (M1) contralateral to the most painful site (C3 or C4 based on the electroencephalogram 10/20 system). During sham tDCS, the electrodes will be placed in the same montage as the active tDCS; however, current will only be applied for the initial and final 30 seconds of the 20-minute session. Consequently, participants will experience the sensation of current ramping up and down but will receive no current for the remaining stimulation period.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

The Arthritis Society, Canada

Collaborator

Trials

27

Recruited

9,700+

Published Research Related to This Trial

The biomechanically-based yoga exercise program (YE) significantly improved pain and self-reported physical function in women with knee osteoarthritis compared to a no-exercise control group, indicating its efficacy as a treatment option.

While the yoga program showed similar improvements to traditional exercise (TE) in pain and function, TE was more effective in increasing knee flexor strength, suggesting that both exercise types have unique benefits for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a biomechanically-based yoga exercise program in knee osteoarthritis: A randomized controlled trial. Kuntz, AB., Chopp-Hurley, JN., Brenneman, EC., et al.[2018]

Mind-body exercise programs, such as Hatha Yoga and Tai Chi, have been shown to effectively improve pain relief and physical function in patients with knee osteoarthritis, based on a systematic review of high-quality studies.

Hatha Yoga and Tai Chi Qigong received high grades for their effectiveness, with significant improvements noted in pain relief and quality of life, making them valuable non-traditional exercise options for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part one: introduction, and mind-body exercise programs. Brosseau, L., Taki, J., Desjardins, B., et al.[2022]

In a study of 83 older adults with knee osteoarthritis, Hatha yoga (HY) showed significant improvements in OA symptoms, anxiety, and fear of falling compared to aerobic/strengthening exercises (ASE) after 8 weeks.

Both HY and ASE were effective in improving symptoms and function, but HY may offer additional benefits, making it a potentially superior option for managing knee OA in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial. Cheung, C., Wyman, JF., Bronas, U., et al.[2018]

An 8-week Sit 'N' Fit Chair Yoga program significantly reduced pain interference and improved gait speed and fatigue in older adults with lower extremity osteoarthritis, with a 95% retention rate among participants.

The reduction in pain interference was sustained for 3 months after the intervention, suggesting chair yoga could be a beneficial nonpharmacologic treatment option for managing osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of the Effects of Chair Yoga on Pain and Physical Function Among Community-Dwelling Older Adults With Lower Extremity Osteoarthritis. Park, J., McCaffrey, R., Newman, D., et al.[2022]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

The integrated approach of yoga therapy (IAYT) significantly improved functional mobility and strength in individuals with knee osteoarthritis, as evidenced by reductions in the Timed Up and Go Test (TUG) and improvements in handgrip strength after just one week of intervention.

Participants in the yoga group showed significant enhancements in flexibility and mobility, with notable improvements in knee extension and flexion, indicating that IAYT can be an effective non-pharmacological treatment for managing symptoms of knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Yoga Based Lifestyle Intervention on Patients With Knee Osteoarthritis: A Randomized Controlled Trial. Deepeshwar, S., Tanwar, M., Kavuri, V., et al.[2020]

Yoga has been shown to have positive effects on various health conditions, particularly chronic pain, hypertension, depression, and supportive cancer care, based on numerous randomized controlled trials.

The risk of serious adverse events from practicing yoga is very low, making it a safe and effective complementary therapy alongside other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Where and How does Yoga Work? - A Scientific Overview]. Cramer, H.[2017]

A 12-week yoga-based strengthening program significantly reduced pain and improved knee strength and mobility in 38 women over 50 with knee osteoarthritis, demonstrating its potential as an effective intervention.

While the program did not improve overall fitness or reduce peak knee adduction moment during walking, it successfully maintained lower knee loads during yoga postures compared to normal gait, suggesting a safer exercise option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Yoga Strengthening Program Designed to Minimize the Knee Adduction Moment for Women with Knee Osteoarthritis: A Proof-Of-Principle Cohort Study. Brenneman, EC., Kuntz, AB., Wiebenga, EG., et al.[2018]

Yoga may help reduce pain, improve physical function, and decrease stiffness in individuals with knee osteoarthritis compared to both exercise and non-exercise control groups, based on a review of nine trials involving 640 participants aged 50-80 years.

However, the evidence is of very low quality and subject to potential bias, leading to only a weak recommendation for yoga as a treatment for knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for Osteoarthritis: a Systematic Review and Meta-analysis. Lauche, R., Hunter, DJ., Adams, J., et al.[2020]

This systematic review will analyze randomized controlled trials to determine how effective yoga interventions are for managing osteoarthritis in adults, addressing a growing global health issue.

The review will follow rigorous methodologies and include a wide range of databases to ensure comprehensive coverage, aiming to identify key characteristics of effective yoga practices for osteoarthritis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content, Structure and Delivery Characteristics of Yoga Interventions for the Management of Osteoarthritis: A Systematic Review Protocol. Biswas, I., Lewis, S., Chattopadhyay, K.[2022]

In a study of 2508 yoga class attendees, about 27.8% reported experiencing adverse events, primarily mild musculoskeletal symptoms, indicating that while yoga is generally safe, some participants may face risks, especially those with chronic conditions.

Participants with chronic diseases, poor physical condition, or those who found the class stressful had a higher likelihood of experiencing adverse events, particularly severe ones in elderly individuals and those with chronic musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. Matsushita, T., Oka, T.[2022]

Yoga may serve as an effective first-line nonpharmacological treatment for osteoarthritis (OA), with evidence suggesting it can reduce pain, sleep disturbances, and disability, although current research is limited.

The proposed mechanisms of yoga's benefits for OA include improvements in musculoskeletal strength and flexibility, reduced stress responses, and enhanced cognitive patterns like mindfulness, which could help patients manage their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for osteoarthritis: nursing and research considerations. Taibi, DM., Vitiello, MV.[2012]

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