Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Quantitative Stimulus Testing (QST)-Thermal
研究概览
简要总结
This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data.
详细描述
In this study patients have been implanted with an Abbott spinal cord stimulator capable of delivering both tonic (continuous) stimulation as well as Burst (intermittent) stimulation. Patients are programmed to be in both stimulation modes for a study period of 4 weeks, after which their pain symptoms are evaluated on a variety of surveys: McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) and Global Improvement. They also undergo Quantitative Sensory Testing (QST), where thermal, mechanical, vibration and pressure stimuli are applied to the patient and detection limits are documented.
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
- Single (Investigator)
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
- •Albany Medical Center neurosurgery patients with chronic leg and/or back pain, that have, or are going to have, spinal cord stimulator implantation.
- •Patients are >/= 18 years old at the time of enrollment.
- •Patients must be: fluent in English; mentally competent; able to read and answer questionnaires; complete pain assessments; and give informed consent.
排除标准
- •Patients less than 18 years old.
- •Patients unable or unwilling to: read and answer questionnaires; complete pain assessments; and give informed consent.
研究组 & 干预措施
Tonic spinal cord stimulation
Patients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks.
干预措施: Spinal Cord Stimulator (Device)
Burst spinal cord stimulation
Patients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks.
干预措施: Spinal Cord Stimulator (Device)
结局指标
主要结局
Quantitative Stimulus Testing (QST)-Thermal
时间窗: Change from baseline to 4 weeks
Thermal stimulus testing - thermal stimulation system is used to record hot and cold sensation and pain thresholds.
次要结局
- Numerical Rating Scale (NRS)(Change from baseline to 4 weeks)
- Pain Catastrophizing Scale (PCS)(Change from baseline to 4 weeks)
- Epworth Sleepiness Scale (ESS)(Change from baseline to 4 weeks)
- Quantitative Stimulus Testing (QST)-Sensitivity(Change from baseline to 4 weeks)
- Quantitative Stimulus Testing (QST)-Pressure(Change from baseline to 4 weeks)
- McGill Pain Questionnaire (MPQ)(Change from baseline to 4 weeks)
- Oswestry Disability Index (ODI)(Change from baseline to 4 weeks)
- Beck's Depression Inventory (BDI)(Change from baseline to 4 weeks)
- Insomnia Severity Index (ISI)(Change from baseline to 4 weeks)
- Quantitative Stimulus Testing (QST)-Vibration(Change from baseline to 4 weeks)