NCT02403518终止不适用
A Prospective, Multi-National, Post-Marketing Study of the Clinical Outcomes of Wireless Neuromodulation Via the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Curonix LLC
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percentage of pain relief experienced in the area of pain identified at baseline compared to 12 months post full implant of the Freedom SCS system.
研究概览
简要总结
This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain. Patients who have been diagnosed with failed back surgery syndrome (FBSS) will receive a stimulator device for treatment of their pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Appropriate Freedom SCS candidate as affirmed by study investigator
- •Candidate has a stable spine not suitable for further surgery as confirmed by physician
- •18 years of age or older (no upper age limit)
- •Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic, intractable pain of the legs, back, or both legs and back
- •At least 6 months since last surgical procedure on the spine
- •Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain)
- •Pain duration of at least 6 months
- •Expected lifespan of at least two years
- •Able to comply with study requirements
- •Gives informed consent for study participation
排除标准
- •A consistent VAS score of 100 over the past 24 hours as established at Visit 1
- •A co-existing condition that could increase the risk of SCS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by SCS (e.g., diathermy)
- •Pregnant or planning to become pregnant
- •Known or suspected substance abuse within the last 2 years
- •Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion
- •Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events)
- •Documented allergy to Freedom SCS material components
- •Co-existing pain condition or participation in another clinical study that could confound the results of this study
- •History of another implanted medical device (e.g., explanted spinal cord stimulator, peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug delivery)
研究组 & 干预措施
Back Pain Only
Active Comparator
Pain localized to the low back or buttocks.
干预措施: Freedom Spinal Cord Stimulator System (Device)
Leg Pain Only
Active Comparator
Pain localized to unilateral pain of the leg (thigh, knee, calf, or foot).
干预措施: Freedom Spinal Cord Stimulator System (Device)
Back and Leg Pain
Active Comparator
Pain localized to both the low back and legs (back, buttocks, thigh, knee, calf, or foot).
干预措施: Freedom Spinal Cord Stimulator System (Device)
结局指标
主要结局
Percentage of pain relief experienced in the area of pain identified at baseline compared to 12 months post full implant of the Freedom SCS system.
时间窗: 12 months
Self reported pain intensity measured by the Visual Analog Scale (VAS)
Incidence and severity of device related adverse events during the study.
时间窗: Up to 12 months
次要结局
- Improved work status.(12 Months)
- Improved quality of life function via the ODI and EQ-5D questionnaires(12 Months)
- Reduced skin to skin time(Average of 7 days after implant)
- To monitor non-device and non-SCS-related adverse events(Up to 12 months)
- Reduced operating theater time(Average of 7 days after implant)
- To assess compliance data to indicate usability of the device.(12 Months)
- To assess the implanters' experience with the device.(Average of 7 days after implant)
- Patient satisfaction with treatment.(12 Months)
- Reduced visits to health care institutes for chronic back and leg pain.(12 Months)
- Reduction in use of analgesics(12 Months)
- Reduced skin to fluoroscope time(Average of 7 days after implant)
研究者
研究点 (1)
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