NCT04016259已完成不适用
Self Cranial Electrical Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
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
- Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this study is to determine the feasibility, safety, and preliminary efficacy of a two-week self Cranial Electrical Stimulation(CES) on 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
- Triple (Participant, Care Provider, 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 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 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
- •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
Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: week 2
The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms
Clinical Pain as Assessed by a Numeric Rating Scale (NRS) for Pain
时间窗: week 2
The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
次要结局
- Psychosocial Symptoms as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form(week 2)
- Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)(week 2)
- Psychosocial Symptoms as Measured by PROMIS - Sleep Disturbance Short Form(week 2)
- Psychosocial Symptoms as Measured by the Pain Catastrophizing Scale (PCS)(week 2)
- Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)(week 2)
- Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)(week 2)
- Experimental Pain Sensitivity as Measured Using a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)(week 2)
- Participant Satisfaction With Treatment Using the Client Satisfaction Questionnaire (CSQ-8)(week 2)
- Psychosocial Symptoms as Measured by PROMIS - Depression Short Form(week 2)
- Number of Participants With a Significant Change in Pain-related Cortical Response on Average as Assessed by a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System(baseline, week 2)
- Feasibility as Measured by the Number of Participants That Completed the Full CES Protocol(week 2)
- Feasibility as Indicated by Participant's Cranial Electrical Stimulation (CES) Experience(week 2)
- Tolerability as Indicated by Number of Participants With Possible Side Effects of Treatment(week 2)
研究者
Hyochol Ahn
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Study of Application of Pulse Electrical Stimulation Around Eye in Glaucoma PatientsGlaucomaNCT05159414Nu Eyne Co., Ltd.18
已完成
不适用
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - St. Joseph Mercy OaklandFibromyalgiaNCT01825954Cerephex Corporation46
已完成
不适用
Cranial Electrical Stimulation Effects on Symptoms in Persons With FibromyalgiaFibromyalgiaNCT00928720University of Virginia57
已完成
不适用
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202FibromyalgiaNCT02613949Cerephex Corporation45
已完成
不适用
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK SurgeryDry Eye DiseaseNCT05271422Nu Eyne Co., Ltd.24