Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy
研究概览
简要总结
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.
详细描述
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional 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 DTM-SCS programming approach
- Control treatment group with Conventional 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.
There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.
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 pain with or without leg pain)
- •Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
- •Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
- •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 written questionnaires, and read, understand and sign the written inform consent.
- •Be 18 years of age or older at the time of enrollment
- •Be on a stable pain medication regimen, 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
- •Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
- •Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
- •Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, 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 a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •Has mechanical spine instability as determined by the Investigator
- •Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
- •Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
- •Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
- •Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)
结局指标
主要结局
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy
时间窗: 3 months
The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.
次要结局
未报告次要终点