A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks
2021年11月16日 更新者：Thomas Jefferson University
Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks
Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB.
In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine.
The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure.
50 subjects will be entered into this study.
This study is being conducted at Thomas Jefferson University only.
研究概览
研究类型
介入性
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.
Exclusion Criteria:
- subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：GONB of lidocaine/bupivacaine
The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally.
The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection.
Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.
|
1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine
|
|
安慰剂比较：Placebo injection of 1/3 saline
The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally.
The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection.
Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.
|
1ml of 1/3 saline
|
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 |
|---|---|---|
|
Percentage of subjects experiencing headache improvement at 2 hours
大体时间：2 hours
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none
|
2 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of subjects experiencing headache improvement 10 minutes
大体时间：10 minutes
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
10 minutes
|
|
Percentage of subjects experiencing headache improvement at 30 minutes
大体时间：30 minutes
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
30 minutes
|
|
Percentage of subjects experiencing headache improvement at 1 hour
大体时间：1 hour
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
1 hour
|
|
Percentage of subjects experiencing headache improvement at 24 hours
大体时间：24 hours
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
24 hours
|
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes
大体时间：10 minutes
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
|
10 minutes
|
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes
大体时间：30 minutes
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
|
30 minutes
|
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour
大体时间：1 hour
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
|
1 hour
|
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours
大体时间：2 hours
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
|
2 hours
|
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours
大体时间：24 hours
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
|
24 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：William B Young, MD、Thomas Jefferson University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月1日
初级完成 (预期的)
2017年12月31日
研究完成 (预期的)
2018年6月30日
研究注册日期
首次提交
2017年4月26日
首先提交符合 QC 标准的
2017年5月16日
首次发布 (实际的)
2017年5月18日
研究记录更新
最后更新发布 (实际的)
2021年11月26日
上次提交的符合 QC 标准的更新
2021年11月16日
最后验证
2021年11月1日
更多信息
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.