NCT03425019已完成不适用
Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and 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 21 人开始时间: 2018年3月14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
- 21
- 试验地点
- 2
- 主要终点
- Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
- •have had knee OA pain in the past 3 months with an average of at least 3 on a 10 cm Visual Analog Scale (VAS) 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 access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit
- •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
- •previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee
- •history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation
- •systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- •uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg)
- •heart failure
- •history of acute myocardial infarction
- •peripheral neuropathy
- •alcohol/substance abuse
- •cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23)
- •pregnancy or lactation
- •hospitalization within the preceding year for psychiatric illness
结局指标
主要结局
Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
时间窗: 2 weeks
Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).
次要结局
- Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale(2 weeks)
- Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale(2 weeks)
- Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale(2 weeks)
- Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale(2 weeks)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)(2 weeks)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)(2 weeks)
- Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale(2 weeks)
- Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale(baseline)
- Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale(2 weeks)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)(2 weeks)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)(2 weeks)
- Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)(2 weeks)
- Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device(2 weeks)
- Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale(2 weeks)
- Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)(2 weeks)
- Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device(2 weeks)
- Tolerability as Assessed by Number of Participants With Side Effects(2 weeks)
- Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time(2 weeks)
- Anxiety as Assessed by the PROMIS Anxiety-short Form(2 weeks)
- Depression as Assessed by the PROMIS Depression-short Form(2 weeks)
- Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form(2 weeks)
研究者
Hyochol Ahn
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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