Burst, Tonic and Sham Spinal Cord Stimulation. A Verification of the Best Treatment Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
研究概览
简要总结
Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.
详细描述
Patients receive three type of stimulation (burst, tonic and sham). We want to compare these different stimulation protocol to verify which one is the one the patient prefer the most and have the least side-effects (paresthesia)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients were selected after multidisciplinary discussion with a specialized pain physician, a psychological and psychiatric evaluation was performed to rule out psychogenic pain as well as other psychiatric morbidity contraindicating an implant. After authorization by the psychologist and psychiatrist an implant was offered.
- •Inclusion Criteria
- •Patients enrolled in this study must meet the following inclusion criteria:
- •Patients able to provide informed consent to participate in the study;
- •Patient is between the age of 18 and 75;
- •Patient has Failed Back Surgery Syndrome;
- •Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
- •Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
- •Patient agrees not to add or increase medication throughout the randomization trial period of the study;
- •Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.
排除标准
- •A patient will be excluded from participation in this study if they meet any one of the following criteria:
- •Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
- •Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
- •Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
- •Patient currently participating in another clinical study;
- •Patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study;
- •Patient is not willing to maintain current medication regimen;
- •Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.
研究组 & 干预措施
Tonic
5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA)
干预措施: dorsal column stimulator (Procedure)
Sham
no stimulation, patient receive a sham stimulation (actually the IPG is not running)
干预措施: dorsal column stimulator (Procedure)
burst
500 hz burst at 5 hz stimulation
干预措施: dorsal column stimulator (Procedure)
结局指标
主要结局
Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
次要结局
- VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire
研究者
Sven Vanneste
Principal investigator
University Hospital, Antwerp