Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Stimulation amplitude changes in response to postural changes
研究概览
简要总结
The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
详细描述
A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature adults between 18 and 70 years old
- •Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions
- •> 50% pain reduction during the trail period
- •Willing and able to comply with the requirements of the protocol including follow-up requirements
- •Willing to sign a study specific informed consent
排除标准
- •Previous SCS treatment
- •Surgically remediable spinal condition
- •Active local or systemic infection
结局指标
主要结局
Stimulation amplitude changes in response to postural changes
时间窗: 6 months
Threshold and therapeutic stimulation parameters in different postures: lying right, lying left, lying prone, lying supine, upright and upright active will be collected for manual and sensor-driven position-adaptive stimulation.
次要结局
- Sleep quality improvement(6 months)
研究者
Alan T. Villavicencio, MD
Principle Investigator
Justin Parker Neurological Institute