Local Sensory Nerve Block in the Treatment of Vestibular Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- DHI(Dizziness Handicap Inventory)
研究概览
简要总结
There is no standard approach to the treatment of vestibular migraine. Agents used in the treatment of migraine are frequently used. In treating migraine, local anesthetic agents, nerve-blocking methods, and botulinum toxin local injection is commonly applied, and successful results are obtained. Adapting the nerve-blocking method used in the treatment of migraine to the treatment of vestibular migraine is the purpose of the study.
详细描述
Patients between 18-75 diagnosed with/without aura or chronic migraine according to IHCD-3 diagnostic criteria and who describe dizziness during or between attacks will be evaluated in the ENT clinic.
Patients included in the study will be recorded as definite vestibular migraine or probable vestibular migraine according to criteria defined in the BARANY community and IHCD-3. Differential diagnosis of vertigo will be made with pure tone audiometry, Caloric test, VHIT, Videonystagmography, and cVEMP. MIDAS (migraine disability scale), DHI (dizziness handicap inventory), VSS (vertigo symptom scale), DASÖ-21 anxiety test, and Allodynia Symptom Checklist (ASKL) forms will be filled.
Patients will be randomly divided into two groups. Patients in the control group will be given beta-blocker therapy, the standard treatment. The local anesthetic agent bupivacaine will be injected into the greater/small occipital nerves and supratrochlear/ supraorbital nerves. Patients in the study group will be asked to keep a diary of pain, dizziness, and painkiller use for one month. At the end of the 1st month, the scoring will be repeated, and the patients who show a decrease in half will be accepted to the next stage, botulinum toxin application. BoNT/A botulinum toxin A (botox; Allergan) will be injected bilaterally into the same regionns. All scoring will be repeated in the 1st, 3rd and 6th months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vestibuler migraine(IHCD3)
- •probable vestibular migraine (IHCD3)
排除标准
- •Systemic disorders unsuitable for injection administration
- •Keloidal scarring
- •Neuromuscular disorders
- •Botulinum toxin allergies
- •Body dysmorphic disorder
- •Pregnancy
- •Breastfeeding
- •Amyotrophic lateralizing sclerosis myopathies
结局指标
主要结局
DHI(Dizziness Handicap Inventory)
时间窗: 6 months
The DHI is a 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. It will be measured at baseline and 6 months after treatment to assess the effects of treatment on vestibular symptoms. Complete recovery will result in significant recovery (\>50%), moderate recovery (25-50% reduction), and minimal recovery (\<25%).
VSS(Vertigo symptom sclae)
时间窗: 6 months
The VSS assesses patient-reported symptoms of vestibüler disease. Complete recovery will result in significant recovery (\>50%), moderate recovery (25-50% reduction), and minimal recovery (\<25%).
MIDAS(Migraine Disability Assessment)
时间窗: 6 months
The MIDAS (Migraine Disability Assessment) questionnaire is used to measure the impact of headaches. It will be measured at baseline and 6 months after treatment to assess the effects of treatment on vestibular symptoms. Complete recovery will result in significant recovery (\>50%), moderate recovery (25-50% reduction), and minimal recovery (\<25%).
次要结局
- The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)(6 months)
- Allodynia Symptom Checklist(6 months)
研究者
Fazıl Necdet Ardıç
Head of Department of Otolaryngology
Pamukkale University