Spinal Cord Stimulation for Chronic and Intractable Back Pain
2020年11月21日 更新者：Boston Scientific Corporation
Spinal Cord Stimulation for Chronic and Intractable Back Pain in Patients Who Are Not Surgical Candidates
The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery or who have chosen to seek alternative therapy.
研究概览
详细说明
Management of symptoms of chronic back pain and/or lumbar radiculopathy is often difficult and inadequate.
Current treatment options include pharmacological treatments, physical therapy, nerve blocks, surgical interruption of the pain pathway, or back surgery.
Many patients either do not have adequate pain management with conventional treatments or are not able to tolerate the treatments due to significant side effects.
Similarly, many patients are either not candidates for surgical interventions, or are unwilling to undergo such procedures.
Spinal cord stimulation has proven to be an effective treatment for patients with pain following a failed back surgery, and this study will investigate spinal cord stimulation as a treatment option for the treatment of chronic back pain in patients who have never had back surgery.
A successful study outcome will establish spinal cord stimulation as a less-invasive treatment option to be considered prior to surgery.
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
San Diego、California、美国、92108
- Huntley Pain Specialists
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Have chronic and intractable neuropathic back pain and/or lumbar radiculopathy of moderate to severe intensity and have elected Spinal Cord Stimulation (SCS) as next line of treatment.
- Be 18 years of age or older.
- Be an appropriate candidate for the surgical procedures required for SCS implant.
- Be willing and able to comply with all study related procedures and visits.
- Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion Criteria:
- Have had any back or spine surgery.
- Have any evidence of neurologic instability or any anatomic problem of the spine that requires surgery.
- Have any other chronic pain conditions likely to confound evaluation of study endpoints.
- Are a current substance abuser (including alcohol and illicit drugs).
- Have a significant psychiatric disorder.
- Have a condition currently requiring or likely to require the use of MRI or diathermy.
- Have an active implantable device.
- Are pregnant or lactating or planning to become pregnant in the next year.
- Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Precision Spinal Cord Stimulation System
Single arm Precision Spinal Cord Stimulation System.
|
Stimulation turned on from implant throughout the Study
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The Primary Objective of This Study is to Evaluate Back Pain Severity at 12 Weeks Post-activation as Compared to Baseline.
大体时间：12 weeks
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2006年2月1日
初级完成 (实际的)
2008年7月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2006年8月30日
首先提交符合 QC 标准的
2006年8月30日
首次发布 (估计)
2006年9月1日
研究记录更新
最后更新发布 (实际的)
2020年12月17日
上次提交的符合 QC 标准的更新
2020年11月21日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.