Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Treatment Efficacy of Intrathecal Infusions
研究概览
简要总结
Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with non-opioid therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Males or females greater than 18 years of age with legal decision making ability.
- •Subjects receiving care at the Brigham and Women's Hospital Pain Management Center.
- •Subjects must have a history of chronic pain > 6 months and must have been a patient in the BWH Pain Center > 6 months.
排除标准
- •Pain due to metastatic cancer or to cancer that is locally invasive
- •Patients with a primary diagnosis of spasticity, receiving intrathecal baclofen
- •Evidence of psychosis or hospitalization for psychiatric illness during study
- •Pregnancy at any time during the study
- •Altered mental status that would make subject unable to complete outcome questionnaires
- •Significant chronic medical illness, such that requires frequent hospitalization or health care utilization (ie: renal failure requiring dialysis, heart failure or cardiac disease requiring surgery or intensive care admission, pulmonary disease requiring intubation or hospitalization, pancreatitis requiring hospitalization, vascular disease requiring surgery or hospitalization, etc.)
结局指标
主要结局
Treatment Efficacy of Intrathecal Infusions
时间窗: March 2014
The primary objective of this study is to evaluate the treatment efficacy of intrathecal infusions for chronic pain and compare this form of therapy to systemic opioid therapy and non-opioid therapy for chronic pain \> 6 months duration.
次要结局
未报告次要终点
研究者
Srdjan Nedeljkovic
Principal Investigator
Brigham and Women's Hospital