NCT02988830已完成不适用
Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Average pain per day on visual analogical scale
研究概览
简要总结
The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •patients over 18 years old
- •Having given their non-opposition
- •Affiliated to a national insurance scheme or beneficiary
- •Suffering for more than a year from a chronic, invalidating lumbago that is refractory in several lines of treatments
排除标准
- •patients with lumbago that can be surgically handled or which justified a medullary stimulation
- •having been operated for the rachis for less than 6 months;
- •which cannot for cognitive or cultural reasons contribute to the planned evaluations and to the management of the material (remote control);
- •for who the investigator can plan that they cannot be followed during one year from the date of the setting-up (non-observance, planned moving, etc.);
- •which present psychological, local or general contraindications to the setting-up of a neurostimulation device (Impossibility to stop anticoagulants or aggregation inhibitors, disturb of the hemostasis, cutaneous infection change on the site of setting-up)
- •MRI planned within the next year
- •pregnant or breast-feeding women.
结局指标
主要结局
Average pain per day on visual analogical scale
时间窗: 12 months
次要结局
- 36-Item Short Form Health Survey score (SF 36)(12 months)
- OSWESTRY DISABILITY INDEX(12 months)
- Douleur neuropathique 4 (DN4) score(12 months)
- Average pain per day on visual analogical scale(15 days)
- Pain Catastrophizing Scale (PCS)(12 months)
- Fear Avoidance Belief Questionnaire (FABQ)(12 months)
- Tampa scale(12 months)
- DALLAS self-questionnaire(12 months)
- Questionnaire Hospital Anxiety and Depression scale (HAD)(12 months)
- Coping strategies questionnaire (CSQ)(12 months)
研究者
研究点 (2)
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