NL-OMON31522已完成不适用
The influence of different flow rates of intrathecal baclofen infusion on dystonia and pain in Complex Regional Pain Syndrome type 1 - ITB flow rate study in CRPS I
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must suffer from tonic or intermittent dystonia in one or more extremities.
- •Patients have an implanted programmable pump (SynchroMed® pump, Medtronic, Minneapolis MN, USA, 40 mL reservoir) for continuous intrathecal drug administration.
- •Patients have shown an insufficient response to intrathecal baclofen (ITB) at the usual flow rate, that is a <25% improvement on dystonia severity while ITB was administered to a level of at least 1000 µg/day or lower because of dose-limiting side effects.
- •Patients must report spontaneous dystonia of at least 5 on a numeric rating scale (0 represents no dystonia, 10 represents worst imaginable dystonia).
排除标准
- •Exclusion criteria are other causes of dystonia and pregnancy
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