Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of subjects experiencing headache improvement at 2 hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: lidocaine/bupivacaine (Combination Product)
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.
干预措施: Saline (Drug)
结局指标
主要结局
Percentage of subjects experiencing headache improvement at 2 hours
时间窗: 2 hours
Headache intensity on 4 point pain scale from moderate or severe to mild or none
次要结局
- Percentage of subjects experiencing headache improvement 10 minutes(10 minutes)
- Percentage of subjects experiencing headache improvement at 24 hours(24 hours)
- Percentage of subjects experiencing headache improvement at 1 hour(1 hour)
- Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours(2 hours)
- Percentage of subjects experiencing headache improvement at 30 minutes(30 minutes)
- Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours(24 hours)
- Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes(10 minutes)
- Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes(30 minutes)
- Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour(1 hour)