NCT07190807招募中不适用
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Targeted Pain Responder Rate
研究概览
简要总结
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).
In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.
- •Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months.
- •18 years of age or older when written informed consent is obtained
- •Able to independently read and complete all questionnaires and assessments provided in English.
- •Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.
排除标准
- •Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
- •Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- •A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
- •Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
研究组 & 干预措施
Time Varied Pulse (TVP)-SCS settings
Experimental
干预措施: Boston Scientific WaveWriter Alpha™ SCS Systems (Device)
结局指标
主要结局
Targeted Pain Responder Rate
时间窗: 3 months post-activation
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
次要结局
未报告次要终点
研究者
研究点 (7)
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