Combining Transcranial Direct Current Stimulation and Yoga for Improved Pain Management for Knee Osteoarthritis: A Pilot and Feasibility Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- McMaster University
- Enrollment
- 68
- Locations
- 3
- Primary Endpoint
- Percentage of complete follow up
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Background: 'Omnipresent' is a common word that people living with knee osteoarthritis (KOA) use to describe the associated pain, with its unpredictability causing physical, social and emotional disruption. For many, KOA pain leads to limited mobility, reduced quality of life and increased healthcare costs KOA pain and its mechanisms are known to be complex, with alterations in nervous system signaling (ANSS) leading to persistent pain, and treatment failure to guideline-based care. Unfortunately, there is a lack of effective conservative treatments for KOA pain, including exercise which elicits only modest analgesic effects and has little impact on ANSS. To improve conservative pain management for people with KOA, it is imperative to design mechanism informed interventions and explore bold new ways to modulate ANSS to optimize patient outcomes. The investigators' novel intervention is focused on addressing the biomarker of ANSS. The investigators' solution involves using non-invasive brain stimulation (NIBS) in the form of transcranial direct current stimulation (tDCS), paired with the mind-body practice of yoga, to modify neural pathways. This is a promising and safe alternative to medications - which risk habituation, adverse events, and addiction - and that builds on the limited efficacy of performing/examining exercise in isolation. To the investigators' knowledge, this is the first trial to use this combination for chronic pain and in people with KOA. The investigators have chosen this combination as tDCS has the potential to produce synergistic nervous system effects with yoga and bolster impacts on pain. tDCS alleviates pain in older adults with KOA, particularly when combined with strengthening exercise or mindfulness. tDCS has demonstrated improved efficiency of conditioned pain modulation (CPM) resulting in pain reduction in older adults with KOA displaying deficient CPM. Meta-analyses of tDCS for the treatment of chronic pain report small to moderate effects on pain reduction, while a meta-analysis of NIBS (including tDCS) plus exercise showed moderate to large effect sizes (-0.62) compared to sham NIBS plus exercise. The investigators' approach combining 13 sessions of tDCS with yoga provides the benefits of strengthening and mindfulness in addition to nervous system regulation with the potential to produce large effects for pain reduction. Yoga modulates brain networks and is safe and accessible for many with KOA Importantly, yoga is safe for people with comorbidities through its combination of physical postures, breathing exercises, meditation and relaxation that are hypothesized to reduce pain by regulating top down and bottom-up input into the physiological systems modulating nociceptive signals. Evidence from fMRI studies indicates that yoga modifies functional connectivity in networks involved in chronic pain. Yoga is conditionally recommended by KOA guidelines due to low quality evidence and few studies. The current project seeks to shift the current paradigm for conservative pain management for people with KOA by assessing a pain mechanism informed treatment strategy in a multi-center pilot and feasibility randomized controlled trial. The investigators hypothesize that real tDCS and yoga will provide clinically meaningful reductions in pain compared to sham tDCS and yoga. This is a feasibility and pilot double-blind, randomized sham-controlled multi-center, two-arm clinical trial with a 1:1 allocation ratio. Participants will be randomized to receive active or sham tDCS and yoga for 9 weeks. Follow-up will occur at the end of the intervention and at 3 months. The Conceptual Framework for Defining Feasibility and Pilot studies, and the Standard Protocol Items- Recommendations for Intervention Trials will be used. Study results will be reported using the extended CONSORT guideline for pilot trials and the Check List Standardizing the Reporting of Interventions For Yoga (CLARIFY).
Investigators
Eligibility Criteria
Inclusion Criteria
- •community dwelling adults from Sherbrooke, Quebec, Hamilton and London, Ontario fulfilling the NICE criteria for KOA
- •≥45 years of age
- •Diagnosis of Knee osteoarthritis OR
- •Having movement-related joint pain with either no morning knee stiffness or stiffness of 30 minutes or less AND
- •Experiencing an average pain intensity of ≥3 /10 in the past month
Exclusion Criteria
- •Systemic inflammatory arthritis.
- •Any knee injection in the past 3 months.
- •Inability to independently get up and down from the floor.
- •Lower limb trauma or surgery within the last 6 months.
- •Current participation in another OA clinical trial.
- •Use of mobility aids.
- •Currently receiving care for KOA pain (e.g., physiotherapy).
- •Planned absences exceeding 1 week.
- •Contraindications to transcranial direct current stimulation (tDCS) such as neurological or neuropsychiatric conditions.
- •History of brain surgery or tumor.
Outcomes
Primary Outcomes
Percentage of complete follow up
Time Frame: 9 weeks and 3 months
Percentage rate measured by those at baseline completing study follow up measures
Secondary Outcomes
- Pain catastrophizing(9 weeks and 3 months)
- Brief Pain Inventory - Numeric Rating Scale(9 weeks and 3 months)
- How likely are you to recommend the program you attended for others with knee OA?(9 weeks)
- How burdensome did you find completing the questionnaires?(3 months)
- How burdensome did you find completing the physical assessments?(9 weeks)
- rate of adherence measured by percentage of sessions attended and home sessions completed(9 weeks)
- Endogenous pain modulation(9 weeks)
- Hospital Anxiety and Depression Scale (HADS)(9 weeks and 3 months)
- Knee Awareness(9 weeks and 3 months)
- Adverse events(9 weeks)
- Pain interference(9 weeks and 3 months)
- Patient global impression of change(9 weeks and 3 months)
- Blinding effectiveness(3 months)
- Acceptability of the delivery of the brain stimulation on a 5 point Likert scale(9 weeks)
- Acceptability of the delivery of the yoga session of the program on a 5 point Likert scale(9 weeks)
- Modified Charlson Comorbidity Index (CCI)(9 weeks and 3 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(9 weeks and 3 months)
- Functional leg strength(9 weeks)
- Usefulness of the program for managing knee OA measured on a 5 point Likert scale(9 weeks)
- Duration of the program on a 5 point Likert scale(9 weeks)
- Multi-joint pain; Body diagram(9 weeks and 3 months)
- Medication use(9 weeks and 3 months)
- Frequency of the program measured on a 5 point Likert scale(9 weeks)