Effects of Transcranial Direct Current Stimulation and Transcranial Ultrasound on the Perception of Pain Due to Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 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 see the effects of transcranial direct current stimulation (tDCS) on the pain associated 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. Before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STUDY ELIGIBILITY CRITERIA
- •Inclusion Criteria:
- •Providing informed consent to participate in the study
- •18 to 64 years old
- •Having chronic osteoarthritis knee pain in either knee (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
- •Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
- •Must have the ability to feel pain as self reported
排除标准
- •Subject is pregnant.
- •Contraindications to tDCS:
- •metal in the head
- •implanted brain medical devices
- •Contraindications to TUS:
- •metal in the head
- •implanted brain medical devices
- •History of alcohol or drug abuse within the past 6 months as self reported
- •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 neurological disorders as self reported.
- •History of unexplained fainting spells as self reported,
- •History of head injury resulting in more than a momentary loss of consciousness as self reported
- •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
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 chronic osteoarthritis pain, as measured by changes in the Visual Analogue Scale (VAS) for pain. VAS will be measured immediately before the tDCS stimulation sessions, and immediately after the tDCS stimulation sessions for the subject's duration in the trial. VAS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
次要结局
- Changes in cutaneous allodynia/hyperalgesia(Measured for approximately 2 months)
- Assessment of hemodynamic changes with transcranial ultrasound(Measured for approximately 2 months)
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital