NCT04016272已完成不适用
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
研究概览
简要总结
The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have symptomatic knee OA based on American College of Rheumatology Clinical criteria
- •have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain
- •can speak and read English
- •have no plan to change medication regimens for pain throughout the trial
排除标准
- •prosthetic knee replacement or nonarthroscopic surgery to the affected knee
- •history of brain surgery, brain tumor, seizure, stroke or intracranial metal implantation
- •systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- •alcohol/substance abuse
- •current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
- •diminished cognitive function that would interfere with understanding study procedures(i.e., Mini-Mental Status Exam score ≤ 23)
- •pregnancy or lactation
- •hospitalization within the preceding year for psychiatric illness
- •no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
结局指标
主要结局
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
时间窗: baseline, week 3
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
次要结局
- Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System(Baseline, week1, week2, and week 3)
- Acceptability as Measured by the tDCs Experience Questionnaire(week 3)
- Number of Participants With Possible Side Effects of Treatment(week 3)
- Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol(week 3)
研究者
Hyochol Ahn, PhD
Associate Dean for Research & Professor
Florida State University
研究点 (2)
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