Ultrasound-guided Greater Occipital Nerve Injection at Novel Proximal Location: A Clinical Series
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Successful anesthesia of the GON
研究概览
简要总结
This study is designed to answer the question of whether injection of the greater occipital nerve at its proximal origin, near the C2 vertebrae, using ultrasound guidance is effective in improving pain in human subjects.
HYPOTHESES
- Ultrasound (US) guided greater occipital nerve (GON) injections are effective at a novel, proximal C2 location in live, human subjects, measured by improvement in visual analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection, and 1-month post-injection .
- Ultrasound (US) guided injection of the greater occipital nerve (GON) at a novel, C2 location is effective at improvement of both occipital neuralgia and cervicogenic headache demonstrated by improvement in visual analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection, and 1-month post-injection. We further hypothesize that the mean improvement in VAS scores at 1-month post injection will be greater than 2 units.
- Ultrasound (US) guided injection of the greater occipital nerve (GON) at novel, proximal C2 location in live, human subjects appears safe.
详细描述
Patients must be referred to Pain Clinic for occipital nerve injection.
Patients are responsible for all clinical costs associated with the injection.
There is no remuneration offered for participation in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must be referred to the Pain Clinic for an occipital nerve injection.
- •Must have Occipital Neuralgia and/or Cervicogenic Headache
排除标准
- •Bilateral GON symptoms and/or cervicogenic headache symptoms
- •History of cervical spine surgery/procedure or trauma in past 6 months that may have caused or contributed to the occipital pain or cervicogenic headache, excluding Occipital Nerve Blocks (ONB).
- •Evidence of impaired sensation in the GON dermatome region
- •Evidence of cranial defect/abnormality near target injection site
- •Untreated cutaneous infection, systemic illness, or immunocompromised state
- •History of bleeding tendency or use of anticoagulants
- •History of adverse reaction to anesthetic agents or corticosteroids
- •Occipital nerve block in past 3 months
结局指标
主要结局
Successful anesthesia of the GON
时间窗: 30 minutes post-injection
Demonstration of successful anesthesia post-injection in the dermatomal distribution of the greater occipital nerve following ultrasound guided injections at a novel, proximal C2 location in live, human subjects.
次要结局
- Change in Pain Scores(30 minutes, 2 weeks, 1 month post-injection)
研究者
Matthew Pingree
Assistant Professor of Physical Medicine and Rehabilitation
Mayo Clinic