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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in Pain Scale as Measured by VAS
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 knee as self-reported.
- •Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.
- •Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session.
- •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 as Measured by VAS
时间窗: Baseline and 8 weeks
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome
次要结局
- Average Daily Dose of Acetaminophen Equivalent(8 weeks)
- Changes in Pain Scale as Measured by VAS(Baseline and 4 weeks post-stimulation)
- Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline(Baseline and 8 weeks)
- Percentage Change From Baseline in the Single Leg Standing Balance Test(Baseline and 8 weeks)
- Percentage Change From Baseline in the Step Test(Baseline and 8 weeks)
- Percentage Change in Functional Reach Test From Baseline(Baseline and 8 weeks)
研究者
Felipe Fregni, MD, PhD, MPH
Principal Investigator
Spaulding Rehabilitation Hospital