Role of Greater Occipital Nerve Block in Headache From Spontaneous Intracranial Hypotension: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in headache intensity
研究概览
简要总结
Spontaneous Intracranial Hypotension (SIH) is a debilitating neurological disorder caused by a cerebrospinal fluid leak (CSF), with an estimated incidence of 5 per 100,000 persons per year, of which mostly women between the ages of 35 years and 55 years. The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms, that significantly impact patients' quality of life.
Treatment of SIH usually starts with conservative measures, consisting of strict supine bed rest, hydration, caffeine, and simple analgesics. The vast majority of patients will require invasive treatments for their CSF leak, such as epidural blood patches, fibrin glue patches, endovascular coiling, and/or surgical repair. These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources, which implicates a certain waiting time for the patients before permanent treatment is offered. In the meantime, due to the lack of an effective and accessible alternative, patients continue to suffer.
The greater occipital nerve block (GONB) has been reported as a simple, safe, and effective treatment to provide short-to-intermediate term relief of migraine, cervicogenic headache, cluster headache, occipital neuralgia, and more recently, post-dural puncture headaches (PDPH). As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar, it is stipulated that the effect of GONB will be similar for SIH patients. However, to date, no studies exploring the efficacy of GONB for SIH have been performed.
The investigators propose to do a prospective observational study to explore the outcome of GONB for SIH. GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment. Moreover, GONB can be performed by physicians of different specialties including neurology, which makes it an accessible treatment for all patients. Lastly, by offering better symptom control, this intervention could potentially restore patients' ability to work and reduce healthcare costs.
详细描述
This a prospective observational study on 34 patients with SIH, recruited from the Toronto Western Hospital Intracranial Hypotension Clinic. Patients will receive an ultrasound-guided bilateral GONB of 5 mls of injectate of mix of local anesthetic with steroid. There is no comparator. Primary outcome is the change in intensity of headache at 30 minutes post-intervention. Secondary outcomes are change in intensity up to day 14 post-intervention, onset of headache, sitting endurance, change in SIH-associated central nervous system (CNS) symptoms, emotional functioning, patient satisfaction, analgesic consumption and side-effect, up to 14 days post-intervention
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults of > 18 years of age
- •Diagnosis of SIH, according to the International Classification of Headache Disorder (ICHD-3) classification (2)
- •Characteristics of pain:
- •Baseline pain intensity NRS > 4/10 (in upright position)
排除标准
- •Contraindications to GONB: ongoing infection (systemic or located at the site of injection), intake of anticoagulants (not aspirin), allergy to injectate, contra-indication to injectate of steroids
- •Any significant cognitive or language barrier that impedes participation
- •Patients taking opioid medications with daily Oral Morphine Equivalent (OME) of 50 mg or higher
- •Patient refusal
结局指标
主要结局
Change in headache intensity
时间窗: 30 minutes post intervention
The difference in the change in intensity of headache, as measured on an 11-point Numerical Rating Scale (NRS), measured 30 minutes after the intervention, after being positioned in an upright position for 10 minutes, compared to baseline.
次要结局
- Onset of headache(at 30 minutes post-intervention and on the morning of day 1, 3, 7, and 14 post-intervention)
- Sitting endurance(at 30 minutes post-intervention and on the morning of days 1, 3, 7, and 14 post-intervention (in minutes)
- patient satisfaction(at day 14 post-intervention)
- analgesic consumption(daily up to day 14)
- SIH associated central nerve system symptoms, such hearing loss, tinnitus, tremor, balance difficulties(at 30 minutes post-intervention and on days 1, 3, 7, and 14 post-intervention)
- adverse effects(daily up to day 14)
- Level of Pain Catastrophizing(at Day 14 post-intervention)
- pain intensity(day 1,3,7,14)
- Level of generalized anxiety(at day 14 post-intervention)
- Level of depression(at Day 14 post-intervention)
研究者
Anuj Bhatia
Professor
University Health Network, Toronto