适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Numeric Pain Rating Scale - Leg pain
研究概览
简要总结
The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.
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 (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 22 years of age or older at the time of informed consent
- •Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain
- •Implanted with one or more Medtronic leads located in the epidural space within the thoracic area
- •Receiving some level of pain relief with current SCS therapy
- •On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications
- •Read and understand English without assistance
- •Willing and able to comply with all study procedures, study visits, and be available for the duration of the study
排除标准
- •Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia
- •Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)
- •Implanted with both a surgical and percutaneous lead
- •Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation
- •Has had any of the following procedures:
- •Neuroablative procedure within six months
- •Neurolytic block within two months
- •Injection therapy for pain within four weeks
- •Sympathetic block within two weeks
- •Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF
- •Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study
- •Has an untreated psychiatric comorbidity
- •Has serious drug-related behavioral issues
- •Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year
- •Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
- •Participating or planning to participate in another clinical trial while enrolled in this study
结局指标
主要结局
Numeric Pain Rating Scale - Leg pain
时间窗: 12 weeks
次要结局
- Brief Pain Inventory - Pain severity(12 weeks)
- Brief Pain Inventory - Pain interference(12 weeks)
- Quantitative Sensory Testing - Vibration threshold(12 weeks)
- Quantitative Sensory Testing - Electrical stimuli tolerance(12 weeks)
- Numeric Pain Rating Scale - Back pain(12 weeks)
研究者
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