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

家庭经颅直流电刺激和正念冥想联合疗法对老年膝骨关节炎患者临床疼痛和症状的自我管理

• 批准号: 10553423
• 负责人: Hyochol Ahn
• 金额: $ 48.88万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-14 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10553423
• 关键词: Address; Adult; Adverse event; Affect; Area; Brain; Client satisfaction; Clinic; Clinical; Clinical Trials; Combined Modality Therapy; Degenerative polyarthritis; Devices; Double-Blind Method; Elderly; Equipment and supply inventories; Future; Goals; Health Expenditures; Home; Intervention; Investigation; Joints; Knee; Knee Osteoarthritis; Mediator of activation protein; Meditation; Modality; Motor Cortex; Neuronal Plasticity; Numeric Rating Scale; Pain; Pain management; Participant; Peripheral; Persons; Pharmaceutical Preparations; Pharmacology; Phase; Public Health; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Research; Risk; Secure; Self Administration; Self Management; Somatosensory Cortex; Supervision; Symptoms; System; Testing; Time; United States; United States Food and Drug Administration; Videoconferencing; Western Ontario and McMaster Universities Arthritis Index; arm; base; central pain; chronic musculoskeletal pain; clinical care; clinical pain; comorbidity; conditioned pain modulation; design; disability; evidence based guidelines; experience; frontal lobe; functional near infrared spectroscopy; hemodynamics; improved; indexing; innovation; insight; interest; mindfulness; osteoarthritis pain; pain processing; pain reduction; pain self-management; pain sensitivity; pain symptom; prescription pain reliever; real time monitoring; response; satisfaction; side effect; spectroscopic imaging; success; symptom management; tool; treatment effect

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.

抽象的 该项目的长期目标是改善膝盖老年人的临床疼痛和症状 骨关节炎（OA）使用基于家庭的非药物方法。膝盖OA是最常见的 超过45岁的人中的疼痛状况以及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重大不良事件，治疗益处可能 随着时间的推移减少。此外，膝盖OA疼痛的特征是与疼痛相关的大脑激活增加，可能 解释现有基于外围的治疗的成功有限 膝盖。因此，针对疼痛相关大脑功能的创新非药理干预措施是 需要。两种非药物疼痛治疗，经颅直流刺激（TDC）和 基于正念的冥想（MBM）已被证明可以改善老年人疼痛相关的大脑功能 膝盖OA。拟议研究的理由是，由于TDCS促进了神经可塑性，因此可能 增强MBM的作用，这也刺激了大脑的适应性变化。但是，没有调查 迄今为止已经检查了远程监督的TDC是否在家中与MBM配对可以增强与疼痛有关的 大脑功能并减轻与OA相关的临床疼痛和症状。基于家庭的干预措施至关重要 因为膝盖OA的老年人的活动能力有限，并且最近的技术进步创造了 通过安全的视频会议平台实时监控进行家庭干预的潜力。这 中心假设是，在家中与MBM配对的远程监督的TDC将减轻临床疼痛和 与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。该假设将通过追求以下特定目的来检验：确定 活性TDC与活性MBM配对对临床疼痛和与OA相关的临床症状的影响（特定目标 1）;确定与活动MBM配对的主动TDC对生理心理疼痛处理的影响 （特定目标2）;并确定与活动MBM配对的主动TDC对参与者满意度的影响 使用治疗（特定目标3）。拟议的研究将直接研究远程监督的影响 TDCS与MBM在家里配对200名有症状膝关节OA的老年人，使用双盲 随机，假对照，II期并行组（由2x2阶乘设计定义的四组1：1：1：1） 设计。拟议的研究很重要，因为它有望为令人兴奋的有价值的见解提供宝贵的见解 非药理学疼痛自我管理的新方式极为轻松，安全且无创。 最小的副作用。