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老年膝关节炎患者的临床疼痛和症状。 骨关节炎（OA）使用家庭为基础的非药物方法。膝关节OA是最常见的 45岁以上人群的疼痛状况，OA疼痛的管理具有挑战性，因为 现有的药理学方法经常产生显著的不良事件，并且治疗益处可能 随着时间的推移而减少。此外，膝关节OA疼痛的特点是增加疼痛相关的大脑激活，可能 解释了针对该区域局部疼痛的现有外周治疗的有限成功 的膝盖。因此，针对疼痛相关脑功能的创新性非药物干预是 needed.两种非药物疼痛治疗，经颅直流电刺激（tDCS）和 正念冥想（MBM）已被证明可以改善老年人与疼痛相关的大脑功能 膝关节OA这项研究的基本原理是，由于tDCS促进神经可塑性，它可能 增强MBM的效果，这也刺激了大脑的适应性变化。然而，没有调查 迄今为止，我们已经研究了远程监督的tDCS与MBM在家里配对是否可以增强疼痛相关的 脑功能和减少OA相关的临床疼痛和症状。家庭干预至关重要 因为患有膝关节OA的老年人活动能力有限，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测的家庭干预的潜力。的 中心假设是远程监督的tDCS与在家的MBM配对将减少临床疼痛， OA相关的临床症状，改善生理心理疼痛处理，并增加参与者 对治疗的满意度。将通过追求以下具体目标来检验这一假设： 活性tDCS与活性MBM配对对临床疼痛和OA相关临床症状的影响（特定目的 1）;确定与主动MBM配对的主动tDCS对生理心理疼痛处理的影响 （具体目标2）;并确定积极的tDCS与积极的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， 在200名患有症状性膝关节OA的老年人中，使用双盲， 随机化、假手术对照、II期平行组（通过2x2析因设计定义的4个组为1：1：1：1） 设计拟议的研究是重要的，因为它有望提供一个令人兴奋的有价值的见解 一种新的非药物性疼痛自我管理方式，非常简单，安全，无创， 最小的副作用

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.