Combining Transcranial Direct Current Stimulation and Yoga for Improved Pain Management for Knee Osteoarthritis: A Pilot and Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- Percentage of complete follow up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Active tDCS
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
干预措施: Yoga (Procedure)
Sham tDCS
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.
干预措施: Yoga (Procedure)
结局指标
主要结局
Percentage of complete follow up
时间窗: 9 weeks and 3 months
Percentage rate measured by those at baseline completing study follow up measures
次要结局
- 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)