a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation
研究概览
简要总结
08-SMI-2012 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic 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 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 DRG within the past 3 months
- •Subject currently has an active implantable device including implantable 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 trial 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
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation
时间窗: Post implantation at; 1, 3, 6, 12 and 24 months
The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain. Jensen, Mark P., Connie Chen, and Andrew M. Brugger. "Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain." The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., \& French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain.
次要结局
未报告次要终点