BurstDR™ micrOdosing stimuLation in De-novo Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.
详细描述
Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.
In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to provide informed consent to participate in the study;
- •Subject diagnosed with chronic intractable pain associated with back and/or limbs;
- •Subject is 18 years of age or older;
- •Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections;
- •Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline;
- •Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;
- •Subject is on stable pain medications with a total opioid for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase until the 3 month visit;
- •Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
- •Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study
排除标准
- •Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;
- •Subject is currently participating in a clinical investigation that includes an active treatment arm;
- •Subject has been implanted with or participated in a trial period for a neurostimulation system;
- •Subject has an infusion pump;
- •Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
- •Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
- •Subject is immunocompromised;
- •Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
- •Subject has history of cancer requiring active treatment in the last 12 months;
- •Subject has an existing medical condition that is likely to require the use of diathermy in the future;
- •Subject has documented history of allergic response to titanium or silicone;
- •Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
- •Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test);
- •Subject has life expectancy of less than 6 months;
- •Subject is involved in an injury claim under current litigation
结局指标
主要结局
Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation
时间窗: baseline and 1 week after trial lead implant (trial stimulation)
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1
时间窗: Baseline and 1 month follow up visit
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3
时间窗: Baseline and 6 month follow up visit
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2
时间窗: Baseline and 3 month follow up visit
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
次要结局
- Change in Disability Index Between Baseline and and Follow up 3(Baseline and 6 month follow up visit)
- Change in Quality of Life Between Baseline and Trial Stimulation(Baseline and 1 week after trial lead implant (trial stimulation))
- Change in Quality of Life Between Baseline and Follow up 1(Baseline and 1 month follow up visit)
- Change in Disability Index Between Baseline and Trial Stimulation(Baseline and 1 week after trial lead implant (trial stimulation))
- Change in Disability Index Between Baseline and and Follow up 1(Baseline and 1 month follow up visit)
- Change in Quality of Life Between Baseline and Follow up 2(Baseline and 3 month follow up visit)
- Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation(Baseline and 1 week after trial lead implant (trial stimulation))
- Change in Quality of Life Between Baseline and Follow up 3(Baseline and 6 month follow up visit)
- Change in Disability Index Between Baseline and and Follow up 2(Baseline and 3 month follow up visit)
- Change in Pain Catastrophizing Scale Between Baseline and Follow up 3(Baseline and 6 month follow up visit)
- Change in Pain Catastrophizing Scale Between Baseline and Follow up 1(Baseline and 1 month follow up visit)
- Change in Pain Catastrophizing Scale Between Baseline and Follow up 2(Baseline and 3 month follow up visit)