NCT02330315已完成不适用
Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Osteoarthritis of the Knee.
Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Changes in Pain Scale
研究概览
简要总结
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent to participate in the study.
- •Subjects between 18-85 years old.
- •Diagnosis of chronic osteoarthritis with pain of either the knee as self-reported.
- •Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail.
- •Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.
- •Pain resistant to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
- •Having the ability to feel pain as self-reported
排除标准
- •Pregnancy or trying to become pregnant in the next 6 months.
- •History of alcohol or drug abuse within the past 6 months as self-reported.
- •Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
- •Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
- •Use of carbamazepine within the past 6 months as self-reported.
- •Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
- •History of unexplained fainting spells as self-reported.
- •Head injury resulting in more than a momentary loss of consciousness
- •History of neurosurgery as self-reported.
结局指标
主要结局
Changes in Pain Scale
时间窗: Measured for approximately 2 months
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).
次要结局
- Changes in Mood(Measured for approximately 2 months)
- Changes in cognition, attention, and focus(Measured for approximately 2 months)
- Adverse Events(Measured for approximately 2 months)
- Single Leg Standing Balance Test(Measured for approximately 2 months)
- Knee Range of Motion (ROM)(Measured for approximately 2 months)
- Step Test(Measured for approximately 2 months)
- Physical Examinations(Measured for approximately 2 months)
- Knee Proprioceptive Test(Measured for approximately 2 months)
- Functional Reach Test(Measured for approximately 2 months)
- Knee Extensor/Flexor Force Test(Measured for approximately 2 months)
- Timed Up and Go Test(Measured for approximately 2 months)
- Changes in quality of life(Measured for approximately 2 months)
- Neurological Examinations(Measured for approximately 2 months)
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital
研究点 (2)
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