Study of the Improvement of Gait by Spinal Stimulation in Patients With Post-operative Chronic Lumbosciatalgia: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To explore the changes in objective walking parameters induced by spinal stimulation in patients with FBSS, after 6 months of chronic stimulation, in comparison with preoperative status.
研究概览
简要总结
The purpose of this study is to explore the changes in objective walking parameters induced by medullary stimulation in patients with Fail Back Surgery Syndrome, after chronic stimulation, in comparison with preoperative condition.
详细描述
After the informed consent signature, a first assessment will be carried out, including: quantified analysis of walking (AQM), felt effort questionnaire, pain questionnaires, functional abilities, limitations, goals and quality of life.
The implantation of the spinal cord stimulation system will be performed in two stages: the first stage, the electrode alone will be implanted and connected to an external test stimulator, allowing a one-week stimulation test.
If the test is positive (EVA pain improvement > or = 50%), the second step will be to connect this electrode to a Spectra WaveWriter™ internal stimulator. This stimulator delivers three different stimulation modalities: tonic, microburst and high frequency. The activated initial stimulation mode will be the tonic one.
After 3 months of "tonic" stimulation, the patient will be treated successively and in random way by 3 other different stimulation modalities during a week: microburst, high frequency, stopped stimulation (Off). The AQM and the different questionnaires will be done again, which will determine which stimulation modality is most beneficial to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 year old and < or = 70 year old
- •Patients with chronic neuropathic lumbo-sciatalgia (DN4 score > or = 4/10) as part of a moderate to severe spinal surgery failure syndrome (EVA >50/100), in who a collegial and multidisciplinary indication of medullary stimulation treatment was chosen.
- •Patients awith Social Security
排除标准
- •Vulnerable persons
- •Patients who are invalid and unable to perform a quantified walk analysis
- •Contraindication to surgery or anesthesia
- •Patient not able to complete questionnaires
- •Woman of childbearing age without effective contraception
研究组 & 干预措施
neurostimulation
3 months of tonic stimutaltion + 3 weeks with random stimulation mode between microburst, High frequency, stopped stimulation (Off) then stimulation with the more efficient mode (according the patient) until 6 monthe after implantation.
干预措施: walking quantified analysis (Other)
结局指标
主要结局
To explore the changes in objective walking parameters induced by spinal stimulation in patients with FBSS, after 6 months of chronic stimulation, in comparison with preoperative status.
时间窗: At baseline, 3 and 6 months after implantation
Gait quantified analysis with Gait Deviation Index
次要结局
- To describe the gait alteration in a population of patients with FBSS(At baseline, 3 and 6 months after implantation)