NCT03747640已完成不适用
Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Meditation for Knee Pain)
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)
研究概览
简要总结
The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain 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
- Double (Participant, 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
- •self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
- •have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) for pain
- •can speak and read English
- •have a device with internet access that can be used for secure video conferencing for real-time remote supervision
- •have no plan to change medication regimens for pain throughout the trial
- •are able to travel to the coordinating center
- •are willing and able to provide written informed consent prior to enrollment
排除标准
- •Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
- •history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- •serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
- •alcohol/substance abuse
- •cognitive impairment
- •pregnancy or lactation
- •hospitalization within the preceding year for psychiatric illness
结局指标
主要结局
Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)
时间窗: baseline, 2 weeks
The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).
次要结局
- Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form(2 weeks)
- Psychosocial Symptoms as Assessed by PROMIS Depression-short Form(2 weeks)
- Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS)(2 weeks)
- Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)(baseline)
- Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline, 2 weeks)
- Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form(baseline)
- Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form(2 weeks)
- Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy(2 weeks)
- Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Medial Knee(baseline, 2 weeks)
- Change in Experimental Pain Sensitivity as Assessed by Pressure Pain Threshold, Lateral Knee(baseline, 2 weeks)
- Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI)(2 weeks)
- Change in Experimental Pain Sensitivity as Assessed by Conditioned Pain Modulation(baseline, 2 weeks)
- Change in Experimental Pain Sensitivity as Assessed by Cold Pain Intensity(baseline, 2 weeks)
研究者
Hyochol Ahn
Associate Professor & Theodore J. and Mary E. Trumble Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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