Stimgenics Open-Label, Post Market Study: A Clinical Trial to Study the Effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) Programs in Treating Intractable Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- The Percentage of Individual Responders
研究概览
简要总结
The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.
详细描述
This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard SCS programming approach.
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
- Test treatment group with SGX-SCS programming approach
- Control treatment group with Standard SCS programming approach
Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
- •Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
- •Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- •Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
- •Be 18 years of age or older at the time of enrollment
- •Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
- •Be willing to not increase pain medications from baseline through the 3-Month Visit
- •Be willing and able to comply with study-related requirements, procedures, and visits
排除标准
- •Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
- •Be concurrently participating in another clinical study
- •Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
- •Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
- •Has mechanical spine instability as determined by the Investigator
结局指标
主要结局
The Percentage of Individual Responders
时间窗: 3 months
Percentage of Participants with a 50% decrease in back pain at 3 months compared to baseline. Pain rating will be measured on the 10 cm Visual Analog Scale (VAS). Change in back pain score will be used to determine individual responder (e.g., 50% reduction in VAS compared to Baseline VAS).
次要结局
- Adverse Events(3 months)
- Percentage of Individual Responders(3 months)
- Change in Back Pain Score(3 months)
- 6 Months Comparison of Back Pain Treatment Success(6 months)
- Oswestry Disability Index (ODI)(3 months)