Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Subject Pain Relief
研究概览
简要总结
The purpose of this study is to evaluate the effect of pulse widths <500 µS and >1000 µS on clinical outcomes during a temporary SCS trial.
详细描述
The proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to include up to 10 subjects in the study. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algostim system with percutaneous leads. Each subject will be followed during the trial period of approximately 7 days.
The study will end when the last subject has completed the trial period. exited. The expected enrollment period for this study is approximately three months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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 eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
- •Study candidate is undergoing a SCS trial using Nuvectra Algostim system
- •Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
- •Subject is 18 years of age or older when written informed consent is obtained
排除标准
- •Subject is contraindicated for an Algovita SCS system
- •Subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
- •Subject has a life expectancy of less than 2 years
- •Subject is participating in another clinical study that would confound data analysis
- •Subject has a coexisting pain condition that might confound pain ratings
- •Subject has a significant psychiatric disorder
研究组 & 干预措施
<500 µS Pulse Width
Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
干预措施: Algovita Spinal Cord Stimulation System (Device)
>1000 µS Pulse Width
Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
干预措施: Algovita Spinal Cord Stimulation System (Device)
结局指标
主要结局
Subject Pain Relief
时间窗: up to 8 days
The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.
次要结局
- Subject Preference(Up to 8 days)
- Distribution of Paresthesia(Up to 8 days)
- Quality of Pain Relief(Up to 8 days)
- Subject Satisfaction(Up to 8 days)
- Achievement of ≥50% Pain Relief(Up to 8 days)
- Rate of AEs(From spinal cord stimulation implant through study completion or study exit, Up to 8 days)
研究者
Amol Soin
Principal Investigator
Kettering Health Network