Superiority, Prospective, Multicentric, Randomized, Single-blind, Cross-over Study Comparing 2 Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 8
- 主要终点
- Change in the visual analog scale for evaluation of radiculalgia (from 0 to 100)
研究概览
简要总结
This study will compare 2 types of Transcutaneous Electrical Nerve Stimulation (TENS) to treat chronic neuropathic pain. TENS involves the application of electrical stimulation to the skin via surface electrodes to stimulate nerve fibres for pain relief.
详细描述
TENS is already recommended in clinical practice to treat chronic neuropathic pain. The objective of this study is to compare the efficacy of 2 different modes of TENS: conventional TENS (c-TENS) and mixed-frequency TENS (m-TENS). Randomization will determine the mode that the patient has to test during the first month.
Each patient will test successively each mode during 1 month at home (3 sessions 1 hour/day). Then, the patient will test the other mode during the second month. Up to 6 months, the patient will be free to use the mode of TENS he wants.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years old or older
- •Patients with chronic neuropathic radiculalgia from at least 3 months of evolution
- •Radiculalgia VAS > or egal to 40/100
- •Neuropathic pain diagnostic (DN4) score > or egal to 4
- •Patient who has accepted to participate in the study by signing the informed consent form
排除标准
- •Pregnancy
- •Dermatosis in the painful dermatome
- •Venous or arterial thrombosis of the lower limbs
- •Patient with active implantable medical device
- •Severe cognitive disorders
- •Patient under a legal protection regime(guardianship/curatorship/guardianship of justice)
- •Previous use of TENS to treat radiculalgia
结局指标
主要结局
Change in the visual analog scale for evaluation of radiculalgia (from 0 to 100)
时间窗: day 30, day 60
Visual analogue scales are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain being 0 equivalent to no pain and 100 to the worst possible pain
次要结局
- Patient preference rate(day 60)
- Patient Global Impression of Change (PGIC)(day 30, day 60)
- Rate of patient compliance(day 30, day 60)
- Rate of patients with adverse events(day 30, day 60, day 180)
- Brief pain inventory (impact on daily life) (BPI)(day 30, day 60)
- Mean of post-effect delay(day 60)
- Visual analog scale for evaluation of radiculalgia one month after(day 30, day 60)
- Visual analog scale for evaluation of radiculalgia six months after(day 180)
- Rate of therapeutic persistence according toTENS mode(day 180)