A Post Market Cohort With the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
研究概览
简要总结
10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is at least 18 years old
- •Subject is able and willing to comply with the follow-up schedule and protocol
- •Peripheral neuropathy for at least 6 months
- •Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
- •Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
- •In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
- •Subject is able to provide written informed consent
排除标准
- •Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
- •Escalating or changing pain condition within the past month as evidenced by investigator examination
- •Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- •Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
- •Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Subject is unable to operate the device
- •Subjects currently has an active infection
- •Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
- •Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator
结局指标
主要结局
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
时间窗: Baseline, 3, 6 and 12-Month Visits
The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).
Percentage of Subjects With at Least 50% Pain Reduction
时间窗: 3, 6 and 12-Month Visits
Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).
次要结局
未报告次要终点