Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
研究概览
简要总结
The purpose of this study is to evaluate and compare the therapeutic efficacy of intermittent Dorsal Root Ganglion Stimulation (DRG-S) to standard continuous stimulation in patients with chronic intractable pain
详细描述
Intermittent Dorsal Root Ganglion Stimulation (DRG-S) dosing consists of preprogrammed cycles during which stimulation is delivered with standard DRG-S parameters alternated with periods during which no stimulation is being delivered.
In this study the investigators propose to evaluate therapeutic efficacy of Intermittent DRG-S at 1 minute on: 1 minute off and 1 minute on: 2 minute off dosing in comparison to standard continuous DRG-S dosing and determine if there is noninferiority between the intermittent and continuous paradigms in chronic pain patients with permanent DRG-S implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded to which stimulation program they are receiving during each 2 week cycle. The Investigator who is also the care provider will be blinded to both the stimulation they are receiving and the sequential order they are given in. The outcomes assessor will be blinded to the sequential order of the stimulation programs each participant receives.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to provide informed consent to participate in the study;
- •Subject is 21 years of age or older;
- •Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief >50% for chronic intractable pain;
- •Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study
排除标准
- •Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study
- •Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study
结局指标
主要结局
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
时间窗: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing
时间窗: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
次要结局
- Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing(After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing)
- Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing(After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing)
- Change in Disability Index Between Continuous and 1:1 Intermittent Dosing(After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing)
- Change in Disability Index Between Continuous and 1:2 Intermittent Dosing(After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing)
研究者
Kenneth Chapman
Principle Investigator
Spine and Pain Institute of New York