Tracking Outcomes in Patients With Chronic Pain Prescribed Intravenous Lidocaine (LID-ISPPC-2023)
Tracking Outcomes by Secondary Diagnoses in Patients Prescribed Intravenous Lidocaine for Chronic Pain
The purpose of this research is to gather data on the performance and functionality of IV lidocaine infusions prescribed to patients with chronic pain.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Victoria Brownlee, MPH
- 电话号码：202-849-8333
- 邮箱：vbrownlee@isppcenter.com
研究联系人备份
- 姓名：John Behun
- 电话号码：202-849-8334
- 邮箱：jbehun@isppcenter.com
学习地点
-
-
District of Columbia
-
Washington D.C.、District of Columbia、美国、20006
- 招聘中
- International Spine Pain & Performance Center
-
接触：
- Victoria Brownlee
- 邮箱：vbrownlee@isppcenter.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult patients with chronic pain who are prescribed to receive an intravenous lidocaine infusion.
描述
Inclusion Criteria:
- Age 18-80 years
- Patients with chronic pain syndrome
- Patients that have been prescribed and scheduled to receive an intravenous lidocaine infusion treatment
Exclusion Criteria:
- Not willing to comply with the requirements of the study
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients with chronic pain who are prescribed to receive an intravenous lidocaine infusion.
|
Intravenous (IV) infusion of lidocaine. Administered to adult patients with chronic pain. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS) at 3 Months
大体时间：Baseline, 3 months post-infusion
|
Pain intensity is self-reported by the patient using the VAS to evaluate their level of pain relief. Scores range from 0 to 100, where 0 indicates no pain and 100 indicates the worst possible pain. A negative change score indicates |
Baseline, 3 months post-infusion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Central Sensitization Index (CSI) at 3 Months
大体时间：Baseline, 3 months post-infusion
|
Evaluates changes in central sensitization symptoms. The CSI consists of 25 items scored from 0 to 4, with a total score ranging from 0 to 100. Higher scores indicate a higher degree of central sensitization. |
Baseline, 3 months post-infusion
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：Baseline, 1 month post-infusion, 3 months post-infusion, 6 months post-infusion, and 12 months post-infusion
|
Evaluates patient-reported health status across multiple domains via the PROMIS-29. |
Baseline, 1 month post-infusion, 3 months post-infusion, 6 months post-infusion, and 12 months post-infusion
|
|
Patient Global Impression of Change (PGIC)
大体时间：1 month post-infusion, 3 months post-infusion, 6 months post-infusion, and 12 months post-infusion
|
Assesses patient-reported satisfaction and overall impression of change regarding their condition following the infusion. |
1 month post-infusion, 3 months post-infusion, 6 months post-infusion, and 12 months post-infusion
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- LID-ISPPC-2023
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.