A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Mean Change in Headache Severity Score
研究概览
简要总结
This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores.
Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a concussion and are greater than 14 days from the date of their injury.
- •Experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.
排除标准
- •Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)
- •Frequent epistaxis (i.e. more than one nose bleed per month),
- •Bleeding disorders
- •History of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block
- •Are at increased risk for methemoglobinemia (including patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to oxidizing agents or their metabolites and drugs associated with methemoglobinemia)
研究组 & 干预措施
Lidocaine in SphenoCath device
One treatment will be given.
干预措施: Lidocaine in SphenoCath device (Combination Product)
Saline Solution in SphenoCath device
One treatment will be given.
干预措施: Saline Solution in SphenoCath device (Combination Product)
结局指标
主要结局
Mean Change in Headache Severity Score
时间窗: 48 hours pre-SPG to 48 hours after SPG block
Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."
次要结局
- Mean Change in Headache Hours Per Day(1 week before SPG block, up to 1 week post SPG block)
- Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block(1 week before SPG block to 1 week post SPG block)
- Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.(1 week before SPG block up to 1 week post SPG)
- Mean Change in As-needed Headache Treatment Uses(1 week before SPG block to 1 week post SPG block)
- Mean Change in the Number of Headache Occurrences(1 week before SPG block, up to 1 week post SPG block)
- Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block(1 week before SPG block up to 1 week post SPG block)
- Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block(48 hours pre SPG up to 48 hours post SPG)
- Patient Global Impression of Change (PGIC)(2, 24 hours after SPG block)
- Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block(48 hours pre SPG to 48 hours post block)
- Mean Change in the Number of Days With Headache(1 week before SPG block, up to 1 week post SPG)
- Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG(48 hours before SPG block to 48 hours post SPG block)
- Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block(1 week before SPG block up to 1 week post SPG block)
研究者
Michael Popovich
Assistant Professor of Neurology
University of Michigan