Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 10
- 主要终点
- Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
研究概览
简要总结
Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated.
The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Patient covered by national health insurance
- •Patient able to express consent
- •Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) > or = 4/
- •Actual or potential neurologic lesion
- •Patient still using a TENS device
排除标准
- •Planned surgery in the next two months
- •Modification of the reatment in the next two motnhs
- •Other study ongoing for the patient
- •Medical contraindication for TENS
结局指标
主要结局
Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
时间窗: day 35 after patient inclusion
Discomfort evaluation will be determined by using VAS (Visual Analogue Scale)
次要结局
- length of TENS daily use(day 35 after patient inclusion)