Algovita Spinal Cord Stimulation System Hi-Fi Study
2021年3月9日 更新者：Nuvectra
Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.
研究概览
研究类型
介入性
注册 (实际的)
20
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
-
-
Arizona
-
Tucson、Arizona、美国、85712
- Pain Institute of Southern Arizona
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-
California
-
Newport Beach、California、美国、92660
- Newport Beach Headache & Pain
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Santa Rosa、California、美国、95401
- Summit Pain Alliance
-
-
Colorado
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Colorado Springs、Colorado、美国、80919
- Spinal Diagnostics & Pain Management
-
-
Kansas
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Overland Park、Kansas、美国、66210
- Mid-America PolyClinic & Interventional Pain Management Specialists
-
-
Louisiana
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Shreveport、Louisiana、美国、71105
- WK River Cities Clinical Research Center
-
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Massachusetts
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Chestnut Hill、Massachusetts、美国、02467
- Brigham & Women'S Hospital
-
-
Ohio
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Chillicothe、Ohio、美国、45601
- Adena Spine Center
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation
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Rhode Island
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Providence、Rhode Island、美国、02903
- Comprehensive Spine Center at Rhode Island Hospital
-
-
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 至 75年 (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:
- Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
- Age 18-75 years old at consent.
- Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
- ODI score of 41-80 out of 100 at the Baseline visit.
- Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
- On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
- Willing and capable of providing informed consent.
- Willing and able of complying with the study-related requirements, procedures, and visits.
- Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
- Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.
Exclusion Criteria:
- Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
- Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
- Has a condition currently requiring or likely to require the use of MRI or diathermy.
- Has an existing drug pump, SCS System, or other active implantable device.
- Has any prior SCS experience.
- Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
- For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
- Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
- Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.
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：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
|
|
有源比较器：Traditional pulse width
Traditional pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
|
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 |
|---|---|---|
|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
大体时间：Week 25
|
The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods. |
Week 25
|
|
Rate of serious study-related adverse events (AEs) in each treatment arm
大体时间：From Permanent Implant through Week 25
|
The rate of serious study-related AEs.
Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
|
From Permanent Implant through Week 25
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
大体时间：Week 12 and Months 12, 18 and 24
|
The percentage of participants who experience at least a 50 percent reduction in targeted pain as assessed by Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
|
Week 12 and Months 12, 18 and 24
|
|
Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain as assessed by Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable).
A higher score indicates a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable).
A higher score indicates a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Clinician Global Impression of Change score in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in disability compared to baseline in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The change from baseline in disability as measured by the Oswestry Disability Index.
The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in quality of life compared to baseline in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in patient activity per the Pain Disability Index score in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The change from baseline in patient activity as measured by the Pain Disability Index score.
The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Patient Global Impression of Change score in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
大体时间：Weeks 12 and 25, and Months 12, 18 and 24
|
Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Evaluation of trial success rates
大体时间：From Trial Implant to End of Trail
|
The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
|
From Trial Implant to End of Trail
|
|
Rate of surgical re-intervention of the SCS system
大体时间：From Permanent Implant through Month 24
|
Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
|
From Permanent Implant through Month 24
|
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)
2018年11月2日
初级完成 (实际的)
2020年4月27日
研究完成 (实际的)
2020年4月27日
研究注册日期
首次提交
2018年7月26日
首先提交符合 QC 标准的
2018年8月7日
首次发布 (实际的)
2018年8月9日
研究记录更新
最后更新发布 (实际的)
2021年3月11日
上次提交的符合 QC 标准的更新
2021年3月9日
最后验证
2021年3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.