Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide IT.
- •Must be 18 years of age or older for all points of data collection.
- •Must be diagnosed with neuropathic pain secondary to a clear etiology. Acceptable etiologies including but not limited to diabetic neuropathy, small fiber neuropathy, and post herpetic neuropathy.
排除标准
- •Must not have or been previously implanted with a programmable pump system.
- •Untreated mental illness including depression or anxiety determined by preoperative psychological evaluation.
- •Active substance abuse determined by preoperative urine drug screen.
- •Unwillingness to decrease oral medications at screening.
- •Any prior use of intrathecal analgesia besides trialing
研究组 & 干预措施
Subjects with Painful Neuropathy
All subjects will be implanted with the Medtronic Synchromed II pump, and treated with the same algorithm for dose adjustment for painful neuropathy with Ziconotide 100 micrograms/ml.
干预措施: Ziconotide 100 MCG(microgram)/ML Intrathecal Solution (Drug)
Subjects with Painful Neuropathy
All subjects will be implanted with the Medtronic Synchromed II pump, and treated with the same algorithm for dose adjustment for painful neuropathy with Ziconotide 100 micrograms/ml.
干预措施: Quantitative sensory testing (Diagnostic Test)
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
This scale allows the subject to quantify their pain numerically, with 10 being the worst pain imaginable. This scale describe subject reported pain at its worst and best in the week prior to reporting, as well as total pain on average, and at the time of documentation. The mean of these scores will be used as the primary outcome. This scale also includes a question of subject experienced global improvement in which the patient is asked to quantify their overall change in pain with 0 being no change and 10 being completely changed. Using the NRS we will calculate a responder rate, assessing percentage of patients with a 50% response in NRS
次要结局
- Oswestry Disability Index Scale(Baseline, 12 weeks, 6 month, 12 month)
- Pain Catastrophizing Scale(Baseline, 12 weeks, 6 month, 12 month)
- SF (Short Form) - 36(Baseline, 12 weeks, 6 month)
- IADL(Instrumental Activities of Daily Living)(Baseline, 12 weeks, 6 month, 12 month)
- Beck Depression Inventory(Baseline, 12 weeks, 6 month, 12 month)
研究者
Julie Pilitsis, MD
MD
Albany Medical College