NCT04375072已完成不适用
Combination Therapy of Home-based Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults With Knee Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Change in Numeric Rating Score (NRS) of Pain
研究概览
简要总结
This clinical trial aims to evaluate whether a 2 week regimen of transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) can improve pain modulation, reduce clinical pain, and alleviate osteoarthritis (OA)-related symptoms in patients with knee 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
- •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
- •diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23)
- •pregnancy or lactation
- •prosthetic knee replacement or non-arthroscopic surgery to the affected knee
- •hospitalization within the preceding year for psychiatric illness
- •no access to a device that can be used for secure videoconferencing for real-time remote supervision.
结局指标
主要结局
Change in Numeric Rating Score (NRS) of Pain
时间窗: baseline, week 2 (after 10 tDCS sessions)
The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement.
次要结局
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).(baseline, week 2 (after 10 tDCS sessions))
研究者
Hyochol Ahn
Dean & Professor
University of Arizona
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple SclerosisMultiple SclerosisNCT03658668NYU Langone Health23
已完成
不适用
Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in StrokeChronic StrokeNCT04059848Kaohsiung Medical University Chung-Ho Memorial Hospital30
已完成
不适用
tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke RecoveryStrokeNCT01983319University of Aarhus64
已完成
不适用
High-definition tDCS Treatment for Cantonese-speaking Adults Who StutterStuttering, AdultStammeringNCT05574803The Hong Kong Polytechnic University10
招募中
不适用
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After StrokeIschemic StrokeCognitive ImpairmentNCT04897334University of Pennsylvania70