NCT03046017招募中不适用
Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- resting state functional connectivity changes
研究概览
简要总结
Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers 21-60 years of age.
- •Meets the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
- •At least 4/10 clinical pain on the 11-point LBP VAS (criteria recommended by Dworkin et al.)
- •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.
排除标准
- •Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections).
- •Complicated back problems (e.g., 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, claustrophobia, epilepsy or acute eczema under the electrodes.
- •Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner.
- •History of medical or psychiatric illness.
- •History of substance / alcohol abuse or dependence.
结局指标
主要结局
resting state functional connectivity changes
时间窗: 2 days; Sessions 5 and 7
fMRI signal changes
时间窗: 2 days; Sessions 5 and 7
Gracely Scale pain rating changes
时间窗: 2 days; Sessions 2 and 7
次要结局
未报告次要终点
研究者
Jian Kong
Associate Professor
Massachusetts General Hospital
研究点 (2)
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