A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 22
- 主要终点
- Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
详细描述
Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study.
The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.
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
- •Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
- •Willing and able to provide a signed and dated informed consent
- •At least 18 years old at the time of informed consent
- •Willing and able to attend visits and comply with the study protocol
- •Capable of using the patient programmer and recharging the neurostimulator
- •Willing to not increase pain medications from baseline through the 3-Month Visit
排除标准
- •Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
- •Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
- •Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
- •Implanted with a cardiac device (e.g., pacemaker, defibrillator)
研究组 & 干预措施
Open label treatment
Spinal Cord Stimulation (SCS)
干预措施: Spinal Cord Stimulation (SCS) (Device)
结局指标
主要结局
Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
时间窗: From baseline to 3 months post device activation
Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).
次要结局
- Patient Global Impression of Change(From baseline to 3 months post device activation)