Combination Therapy of Home-based Trans-cranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults with Knee Osteoarthritis

摘要 该项目的长期目标是改善患有膝关节的老年人的临床疼痛和症状。 骨性关节炎(OA)使用基于家庭的非药物方法。膝骨性关节炎是最常见的 45岁以上人群的疼痛状况，而OA疼痛的管理是具有挑战性的，因为 现有的药理学方法通常会产生严重的不良反应，治疗的益处可能 随着时间的推移而减少。此外，膝骨性关节炎疼痛的特征是与疼痛相关的大脑激活增加，可能 解释现有的针对该地区局部疼痛的外周治疗的有限成功 膝盖的位置。因此，针对疼痛相关脑功能的创新非药物干预措施是 需要的。两种非药物止痛疗法，经颅直流电刺激(Tdcs)和 基于正念的冥想(MBM)已被证明可以改善老年人与疼痛相关的大脑功能 膝盖骨关节炎。提出这项研究的理由是，由于tdcs促进神经可塑性，它可能 增强MBM的作用，这也刺激大脑的适应性变化。然而，没有进行任何调查 到目前为止，我已经检查了远程监控的tdc与家庭中的MBM配合使用是否可以增强疼痛相关 改善脑部功能，减轻骨性关节炎相关的临床疼痛和症状。以家庭为基础的干预措施至关重要 因为患有膝骨性关节炎的老年人活动能力有限，而最近的技术进步创造了 通过安全的视频会议平台进行实时监控的家庭干预的潜力。这个 中心假设是远程监控的TDC与家庭中的MBM配对将减少临床疼痛和 与OA相关的临床症状，改善生理心理疼痛处理，增加参与者 对治疗的满意度。这一假设将通过追求以下具体目标来检验：确定 主动TDC联合主动MBM对临床疼痛和骨关节炎相关临床症状的影响(特定目的) 1)确定主动tDCs与主动MBM配对对生理-心理疼痛处理的影响 (具体目标2)；以及确定主动tDC与主动MBM配对对参与者满意度的影响 治疗(具体目标3)。拟议的研究将直接调查远程监督的影响 采用双盲法对200例有症状的膝关节骨性关节炎患者进行TDC与家庭MBM配对治疗。 随机、假对照、II期平行组(由2x2析因设计确定的四组1：1：1：1) 设计。这项拟议的研究意义重大，因为它有望为一项令人兴奋的 非药物性疼痛自我管理的新模式，极其简单、安全和非侵入性 副作用最小。

ABSTRACT The long-term goal of this project is to improve clinical pain and symptoms for older adults with knee osteoarthritis (OA) using home-based nonpharmacological approaches. Knee OA is one of the most common pain conditions among people over 45 years old, and the management of OA pain is challenging because existing pharmacological approaches often produce significant adverse events, and the treatment benefits may decrease over time. Also, knee OA pain is characterized by increased pain-related brain activation, possibly explaining the limited success of existing peripherally based treatments that target the pain locally in the area of the knee. Therefore, innovative nonpharmacological interventions targeting pain-related brain function are needed. Two nonpharmacological pain treatments, transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM), have been shown to improve pain-related brain function in older adults with knee OA. The rationale for the proposed research is that because tDCS promotes neuroplasticity, it may potentiate the effect of MBM, which also stimulates adaptive changes in the brain. However, no investigations to date have examined whether remotely supervised tDCS paired with MBM at home can enhance pain-related brain function and reduce OA-related clinical pain and symptoms. Home-based interventions are critical because older adults with knee OA have limited mobility, and recent technological advances have created the potential for home interventions with real-time monitoring through a secure videoconferencing platform. The central hypothesis is that remotely supervised tDCS paired with MBM at home will decrease clinical pain and OA-related clinical symptoms, improve physiopsychological pain processing, and increase participant satisfaction with treatment. This hypothesis will be tested by pursuing the following specific aims: determine the effects of active tDCS paired with active MBM on clinical pain and OA-related clinical symptoms (specific aim 1); determine the effects of active tDCS paired with active MBM on physiopsychological pain processing (specific aim 2); and determine the effects of active tDCS paired with active MBM on participant satisfaction with treatment (specific aim 3). The proposed study will directly investigate the effects of remotely supervised tDCS paired with MBM at home in 200 older adults with symptomatic knee OA using a double-blind, randomized, sham-controlled, phase II parallel group (1:1:1:1 for four groups defined by 2x2 factorial design) design. The proposed research is significant because it is expected to provide valuable insight into an exciting new modality of nonpharmacological pain self-management that is extremely easy, safe, and noninvasive with minimal side effects.