The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS) for neuropathic pain
研究概览
简要总结
The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who have chronic neuropathic pain.
详细描述
Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tsDCS (2 mA) over tenth thoracic vertebra for 20 min (reference electrodes on the head vertex). Treatment order was randomly assigned. A evaluator rated the pain using the visual analogue scale for pain, Patient Global Assessment and Present Pain Intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
tsDCS
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20<=age<90
- •neuropathic pain (LANSS score >= 12), stable chronic pain for at least the three preceding months but not over 5 years
- •score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (VAS) for pain perception at the baseline/start of the treatment
- •refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months)
- •informed consent
排除标准
- •patients with any clinically significant or unstable medical or progressive neurologic disorder
- •contraindication for electrial stimulation such as pacemaker implant
- •Women of childbearing age or pregnancy
- •significant cognitive deficit
- •Syringomyelia
- •neuropsychiatric comorbidity
- •depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory)
- •history of substance abuse
- •skin defect under the electrodes
- •progressive neurological disease or other secondary conditions that could impact neuropathic pain
结局指标
主要结局
Numeric rating scale (NRS) for neuropathic pain
时间窗: Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable
次要结局
- Patient Global Assessment (PGA)(Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation)
- Present Pain Intensity (PPI)(Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation)
研究者
Hyung-ik Shin
Professor
Seoul National University Hospital