An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
Researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.
详细描述
The study is a controlled trial with subjects that have an already-implanted SCS device (Eon Mini™) and are not satisfied with their pain relief status. As part of medical standard of care, patients with already-implanted Eon family tonic implantable pulse generators (IPGs) have the opportunity to experience burst stimulation for 30-Day Trial FDA approved. The aim of the study record patients experience during the 30-Day Trial using standard questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Males and females ≥18 years-old
- •Diagnosed with chronic pain
- •Have an already-implanted Eon Family IPG for a minimum period of 6 months
- •Are interested in trying burst technology by reprograming their IPG for 2-3 weeks according to the 30-Day Trial standard of care
- •Signed informed consent
排除标准
- •Subject's overall Beck Depression Inventory II Score is >24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to Baker's act
- •Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation
- •Subject has an infusion pump or any other implantable neurostimulator device
- •Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment
- •Subject's pain originates from peripheral vascular disease
- •Subject is immunocompromised
- •Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
- •Subject has history of cancer requiring active treatment in the last 6 months
- •Pregnancy
结局指标
主要结局
Pain intensity
时间窗: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Change in Pain scores using Numeric Rating Scale (1-10)
Pain quality, intensity and localization
时间窗: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Change in pain perception using Short-Form McGill Pain Questionnaire-2
Pain perception
时间窗: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Change in pain perception using the Pain Catastrophizing Scale self-reported survey
次要结局
- Participant's impression of Quality of Life(Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends)
- Functioning(Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends)
- Depression(Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends)
- Participant self-evaluation of Quality of Life(Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends)
研究者
Michael D. Osborne
Principal Investigator
Mayo Clinic