BINGO: A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Pain Intensity in Overall Pain
研究概览
简要总结
11-SMI-2013 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
- •Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
- •Subject is able to provide written informed consent
排除标准
- •Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration
- •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 ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Subject is unable to operate the device
- •Subjects currently has an active infection
- •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
Pain Intensity in Overall Pain
时间窗: Post treatment at 3, 6 and 12 months
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline 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).
Pain Intensity in Primary Region of Pain
时间窗: Post treatment at 3, 6 and 12 months
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline. 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).
次要结局
未报告次要终点