Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain (NSCLBP).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Conditional Pain Modulation (Hand)
研究概览
简要总结
The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. 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 to 85 years old
- •Subjects having non-specific chronic low back pain with existing pain for at least 3 months and having pain on at least half the days in the past 6 months with an average of at least 3 on a 0-10 visual analog scale (VAS) scale
- •Pain resistant (partial or no response) 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.
- •Must have the ability to feel sensation by Von-Frey fiber on the forearm
排除标准
- •Subject is pregnant
- •Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or 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 severe head injury resulting in more than a momentary loss of consciousness as self reported
- •History of neurosurgery as self reported
- •Unstable pain
- •Large placebo responder
- •Low adherence during the run-in period
- •Low baseline pain
结局指标
主要结局
Changes in Conditional Pain Modulation (Hand)
时间窗: Baseline and 3.5 months
Changes in Conditional Pain Modulation (CPM) will be measured in the hand in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in increasing the pain pressure threshold in subjects with non-specific chronic low back pain.
Changes in Mechanical Temporal Summation (Hand)
时间窗: Baseline and 3.5 months
Changes in Mechanical Temporal Summation (TS) from hand will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in reducing pain of subjects with non-specific chronic low back pain.
Changes in Pain
时间窗: Baseline and 3.5 months
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to measure any changes in pain levels when subjects come in for sessions.
次要结局
未报告次要终点
研究者
Felipe Fregni, MD, PhD, MPH
Principal Investigator
Spaulding Rehabilitation Hospital