Transcranial Direct Current Stimulation and Yoga for Knee Osteoarthritis

Официальное название

Combining Transcranial Direct Current Stimulation and Yoga for Improved Pain Management for Knee Osteoarthritis: A Pilot and Feasibility Trial

Обзор

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.

Подробное описание

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).

Вмешательства

• Процедура Yoga
  Yoga program: In weeks 2-9, participants will attend twice weekly 1-hour sessions of yoga led by a certified yoga instructor trained in the intervention by collaborator Pearson. Videos will be provided for completion of home sessions. The yoga program is based on the Pain Care Aware certification program.38 Details of the program as well as the training of instructors are provided in the appendices. Briefly, classes will consist of 3 parts: centring and warming up aimed at regulating physiology

Первичные конечные точки

• Percentage of complete follow up [Срок оценки: 9 weeks and 3 months]

Вторичные конечные точки (12)

• Brief Pain Inventory - Numeric Rating Scale [Срок оценки: 9 weeks and 3 months]
• Modified Charlson Comorbidity Index (CCI) [Срок оценки: 9 weeks and 3 months]
• Endogenous pain modulation [Срок оценки: 9 weeks]
• Pain interference [Срок оценки: 9 weeks and 3 months]
• Pain catastrophizing [Срок оценки: 9 weeks and 3 months]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 9 weeks and 3 months]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: 9 weeks and 3 months]
• Multi-joint pain; Body diagram [Срок оценки: 9 weeks and 3 months]
• Knee Awareness [Срок оценки: 9 weeks and 3 months]
• Functional leg strength [Срок оценки: 9 weeks]
• Medication use [Срок оценки: 9 weeks and 3 months]
• Adverse events [Срок оценки: 9 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.
• Metallic implants.
• Epilepsy or history of substance abuse or dependence.
• Cochlear or ocular implant.
• Presence of a pacemaker or cardiac defibrillator.
• Eczema on the scalp.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

• McMaster University — Hamilton
• University of Western Ontario — London
• Université de Sherbrooke — Sherbrooke

Публикации

• Wallis JA, Taylor NF, Bunzli S, Shields N. Experience of living with knee osteoarthritis: a systematic review of qualitative studies. BMJ Open. 2019 Sep 24;9(9):e030060. doi: 10.1136/bmjopen-2019-030060. PMID 31551381
• Calders P, Van Ginckel A. Presence of comorbidities and prognosis of clinical symptoms in knee and/or hip osteoarthritis: A systematic review and meta-analysis. Semin Arthritis Rheum. 2018 Jun;47(6):805-813. doi: 10.1016/j.semarthrit.2017.10.016. Epub 2017 Oct 31. PMID 29157670
• Kendzerska T, Juni P, King LK, Croxford R, Stanaitis I, Hawker GA. The longitudinal relationship between hand, hip and knee osteoarthritis and cardiovascular events: a population-based cohort study. Osteoarthritis Cartilage. 2017 Nov;25(11):1771-1780. doi: 10.1016/j.joca.2017.07.024. Epub 2017 Aug 9. PMID 28801210
• Arthritis Alliance of Canada. The Impact of Arthritis in Canada: Today and over the Next 30 years. Executive Summary. 2011.
• Sharif B, Kopec JA, Wong H, Anis AH. Distribution and Drivers of Average Direct Cost of Osteoarthritis in Canada From 2003 to 2010. Arthritis Care Res (Hoboken). 2017 Feb;69(2):243-251. doi: 10.1002/acr.22933. PMID 27159532
• Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018. PMID 23973124
• Fingleton C, Smart K, Moloney N, Fullen BM, Doody C. Pain sensitization in people with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Jul;23(7):1043-56. doi: 10.1016/j.joca.2015.02.163. Epub 2015 Mar 5. PMID 25749012
• Carlesso LC, Segal NA, Frey-Law L, Zhang Y, Na L, Nevitt M, Lewis CE, Neogi T. Pain Susceptibility Phenotypes in Those Free of Knee Pain With or at Risk of Knee Osteoarthritis: The Multicenter Osteoarthritis Study. Arthritis Rheumatol. 2019 Apr;71(4):542-549. doi: 10.1002/art.40752. Epub 2019 Feb 7. PMID 30307131

Идентификаторы

NCT: NCT06228573 · 23-0000000177

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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