Brain Stimulation + Yoga for Osteoarthritis

Recruiting at 2 trial locations

Overseen By Guillaume Leonard, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

Disqualifiers: Systemic inflammatory arthritis, Neurological conditions, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

People with knee arthritis often experience constant pain, and current treatments aren't very effective. This can lead to limited movement and more health problems. Knee arthritis is a big part of healthcare costs in Canada, and its pain is a major reason people see doctors. The pain is linked to complex nervous system changes, making current treatments, like exercise, not very successful. To address this, researchers suggest a new approach combining two things: a brain stimulation technique called Transcranial Direct Current Stimulation (tDCS) and yoga. TDCS helps with pain by changing how the brain works, and yoga, a safe practice, focuses on overall well-being. Together, the investigators aim to improve how the nervous system works from top to bottom. The research project wants to change how the arthritis pain is being managed by focusing on how it works. The investigators plan to test this combo in a study comparing real tDCS plus yoga with fake tDCS plus yoga. The investigators will look not only at pain but also at other measures related to pain and how the nervous system works. This new mix could be a meaningful way to reduce pain for people with knee arthritis.

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 data supports the effectiveness of this treatment for osteoarthritis?

Research suggests that yoga, as part of a mind-body practice, can help reduce pain, improve sleep, and decrease disability in people with osteoarthritis. A study showed that a yoga-based lifestyle intervention improved muscle strength, flexibility, and mobility in individuals with knee osteoarthritis. ^{1 2 3 4 5}

Is yoga generally safe for humans?

Yoga is generally considered safe for humans, with a very low risk of serious adverse events, similar to other forms of physical activity. While some nonserious adverse events have been reported, they are not common, and yoga can be a safe addition to managing various health conditions. ^{1 5 6 7 8}

How does the treatment of yoga differ from other treatments for osteoarthritis?

This treatment combines brain stimulation with yoga, which is unique because yoga is a mind-body exercise that can improve symptoms, mood, and physical function without overloading the knee, unlike some traditional exercises. It also addresses anxiety and fear of falling, which are not typically targeted by standard osteoarthritis treatments. ^{4 9 10 11 12}

Research Team

Lisa Carlesso, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Yoga (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Content, Structure and Delivery Characteristics of Yoga Interventions for the Management of Osteoarthritis: A Systematic Review Protocol. [2022]

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

Yoga for osteoarthritis: nursing and research considerations. [2012]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Yoga Based Lifestyle Intervention on Patients With Knee Osteoarthritis: A Randomized Controlled Trial. [2020]

4. England 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. [2022]

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

Yoga for Osteoarthritis: a Systematic Review and Meta-analysis. [2020]

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

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

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

Efficacy of a biomechanically-based yoga exercise program in knee osteoarthritis: A randomized controlled trial. [2018]

10. United States 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. [2022]

11. United States 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. [2018]

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

Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial. [2018]