NCT06568198招募中2 期
Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Alpha activity at rest
研究概览
简要总结
Investigating the modulation effect of tACS
详细描述
Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers 18-60 years of age
- •Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
- •At least 4/10 clinical pain on the 0-10 LBP NRS
- •At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
- •Meeting the MRI / MEG / EEG screening criteria
排除标准
- •Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
- •Complicated back problems (eg, prior back surgery, medicolegal issues)
- •The intent to undergo surgery during the time of involvement in the study
- •History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
- •Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
- •Concomitant autoimmune, chronic, inflammatory, neoplastic, and psychiatric diseases
- •Pregnant or lactating
- •Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
- •Active substance abuse disorders (based on subject self-report and drug test)
- •Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents
- •Any medical conditions, such as peripheral neuropathy, that could affect the results of QST
- •Current use of psychotropic medication
研究组 & 干预措施
real tACS
Experimental
干预措施: Real tACS (Device)
Sham tACS
Sham Comparator
干预措施: Sham tACS (Device)
结局指标
主要结局
Alpha activity at rest
时间窗: Baseline and week 4
EEG/MEG data will be collected to measure alpha activity.
TC resting state functional connectivity
时间窗: Baseline and week 4
fMRI data will be collected to measure resting state functional connectivity.
Numeric Rating Scale (NRS) for pain intensity
时间窗: Baseline and week 4
The NRS is a uni-dimensional measure of pain intensity that uses an 11-point numeric scale. We will use it to measure the average low back pain intensity in the past week.
次要结局
- Alpha activity during tonic pressure pain(Baseline and week 4)
- TC functional connectivity during tonic pain(Baseline and week 4)
研究者
Jian Kong
Principal investigator
Massachusetts General Hospital
研究点 (1)
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