Comparison of the Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation of the Motor Cortex in Patients With Neuropathic Pain Due to Chronic Radiculopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Comparison of rTMS and tDCS on average pain intensity
研究概览
简要总结
The present study aims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.
详细描述
The present study ims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation (rTMS) and transcranial direct electrical current (tDCS) of the motor cortex in patients with chronic lumbar radiculopathy on average pain intensity. This will be a sham controlled crossover design : patients will be randomized to receive either active rTMS or tDCS during 3 consecutive days followed by the alternative treatment within 3 weeks apart, or sham rTMS or tDCS during 3 consecutive dats followed by the alternative treatment within 3 weeks apart. The investigator will be blind to the treatment. Assessments will be performed before each treatment, then 1 hour after the end of the third day session, then 2 days and 1 week after the stimulation. Assessments will include pain questionnaires, quality of life, anxiety and depression, catastrophizing and evaluation of treatment effect on experimental pain using Quantitative sensory testing.
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Patients aged more than 18 years and less than 60 years, males of females Lumbosciatica or lumbocruralgia with predominant neuropathic components with DN4 score ≥ 4/10 Chronic pain with an intensity of at least 4/10 Stable analgesic treatment for at least 15 days before inclusion Able to speak and understand French Social security
排除标准
- •Work accident or litigation Contraindication to rTMS (sismotherapy in the preceding month, epilepsia, past head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy or lactation Major depressive episode Intermittent pain Consent refusal Impossible to follow up during the duration of the study Pain more severe than neuropathic pain
结局指标
主要结局
Comparison of rTMS and tDCS on average pain intensity
时间窗: 7 days after 3 days of stimulation
Average pain intensity numerical scales (0-10)
次要结局
- Comparison of rTMS and sham stimulation on average pain intensity(7 days after 3 stimulation days)
- comparison of tDCS and sham stimulation on average pain intensity(at 7 days after 3 days of stimulation)
- comparison of rTMS and tDCS on current pain(1 hour after each stimulation session)
- comparison of rTMS versus tDCS and versus sham on BPI interference(7 days after the end of 3 stimulation days)
- comparison of rTMS versus tDCS and sham on pain catastrophizing(7 days after the last day of stimulation (3 days))
- comparison of rTMS versus tDCS and sham on anxiety and depression(7 days after the end of stimulation sessions)
- comparison of rTMS versus tDCS and sham on neuropathic symptoms(7 days after the end of stimulations)
- comparison of rTMS versus tDCS and sham on thermal testing(2 days and 7 days after stimulation days)
- comparison of safety between rTMS and tDCS and between neurostimulation and sham(immediately after each stimulation, then at 2 days and 7 days)
- comparison of rTMS and tDCS on pain intensity(2 days after 3 stimulation days)
研究者
Nadine ATTAL
MD PhD
Hospital Ambroise Paré Paris