Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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La Mesa、California、美国、91942-8901
- Pain Consultants of San Diego
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Orange、California、美国、92868
- Restore Orthopedics and Spine Center
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Delaware
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Wilmington、Delaware、美国、19803
- Center for Interventional Pain and Spine
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Georgia
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Stockbridge、Georgia、美国、30281-5023
- Pain Care
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Maryland
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Oxon Hill、Maryland、美国、20745
- National Spine and Pain
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Michigan
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Wyoming、Michigan、美国、49519
- Michigan Pain Consultants
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Nevada
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Henderson、Nevada、美国、89052
- Comprehensive and Interventional Pain Management
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New Jersey
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Voorhees、New Jersey、美国、08043-3512
- The Pain Management Center
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New York
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Rochester、New York、美国、14618
- University of Rochester Neurosurgery Partners Pain Management
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North Carolina
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Huntersville、North Carolina、美国、28078
- Carolinas Pain Center
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Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University Wexner Medical Center
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Pennsylvania
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Allentown、Pennsylvania、美国、18103
- Lehigh Valley Healthcare Network
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Bethlehem、Pennsylvania、美国、18015
- Saint Luke's Neurosurgical Associates
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Sewickley、Pennsylvania、美国、15134
- Pain Diagnostics and Interventional Care
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Trevose、Pennsylvania、美国、19053
- Delaware Valley Pain and Spine Institute
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South Carolina
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Charleston、South Carolina、美国、29406
- Lowcountry Orthopaedics/Coastal Carolina Research Center
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Spartanburg、South Carolina、美国、29303
- Carolina Center for Advanced Management of Pain
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Texas
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Tyler、Texas、美国、75701
- Precision Spine Care
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Virginia
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Roanoke、Virginia、美国、24014
- Carilion Clinic Roanoke Memorial Hospital
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Washington
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Spokane、Washington、美国、99201
- Northwest Pain Care
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
- Presence of low back and leg pain
- Moderate to crippled disability due to pain
- Stable pain medications for back and leg pain for at least 28 days prior to enrollment
- Willing and able to not increase pain medications through the 3-Month visit
Exclusion Criteria:
- Previously trialed or implanted with stimulator or intrathecal drug delivery system
- Current diagnosis of moderate to severe central lumbar spinal stenosis
- Major psychiatric comorbidity or other progressive diseases
- Serious drug-related behavioral issues
- Pregnant or planning on becoming pregnant
- Unable to achieve supine position
学习计划
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 |
|---|---|
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实验性的：Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
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Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
大体时间：Baseline to 3 months
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Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain. The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study. |
Baseline to 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Pain Efficacy Responder Rate
大体时间：Baseline to 3 months
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Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders). |
Baseline to 3 months
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Low Back Pain Efficacy Responder Rate
大体时间：Baseline to 3 months
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Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders). |
Baseline to 3 months
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Leg Pain Efficacy Responder Rate
大体时间：Baseline to 3 months
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Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder. The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders). |
Baseline to 3 months
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合作者和调查者
调查人员
- 研究主任：Vectors Post Market Clinical Research Study Team、Medtronic Restorative Therapies, Pain Therapy
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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