A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Intractable Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
研究概览
简要总结
04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.
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
- •Chronic, intractable pain in the thoracic, lumbar and/or sacral distribution(s) 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
- •Minimum 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
- •Subject speaks Dutch or English
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 implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Patient has pain only or primarily within a cervical dermatomal distribution
- •Subject is unable to operate the device
- •Subjects with indwelling devices that may pose an increased risk of infection
- •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
- •Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- •Subject has been diagnosed with cancer in the past 2 years
结局指标
主要结局
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
时间窗: 3, 6 and 12-Months
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: Baseline and End of Trial Visit
Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.
次要结局
未报告次要终点