Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Purpose: In this study, the investigators compared the effectiveness of peripheral nerve block (greater occipital nerve block with supratrochlear nerve block) versus topiramate as detoxification therapies in chronic migraine patients with medication overuse headache.
Methods: At least ninety chronic migraine patients with medication overuse headache are aimed to include in this study. Patients will be divided into the two groups. The first group will receive topiramate (n=45, estimated) and the second group will receive nerve block (n=45, estimated) as detoxification therapy. Patients' records regarding the visual analog scale (VAS) scores and headache frequencies are aimed to be collected before and after the therapy. Comparisons regarding VAS scores, headache frequencies, 50% responder rates and 75% responder rates will be performed in between topiramate and nerve block groups.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
- •w/o pregnancy or breastfeeding.
- •w/o acute or chronic psychiatric disorders.
- •w/o nephrolithiasis.
- •w/o medication of anticoagulant and antiaggregant.
- •w/o allergy to topiramate or bupivacaine.
- •w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
- •w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
- •w/o history of multiple sclerosis, movement disorders, epilepsy, stroke, and tumor.
- •J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes, pulmonary disease, kidney disease, liver disease, and peripheral arterial disease.
排除标准
- •Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy
- •could not tolerate the peripheral nerve block or topiramate
研究组 & 干预措施
Topiramate
Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.
干预措施: Topamax (Drug)
Greater Occipital +Supratrochlear Nerve Block
Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
干预措施: Greater Occipital Nerve Block + Supratrochlear Nerve Block (Procedure)
结局指标
主要结局
Visual Analog Scale
时间窗: Post treatment (4 weeks later)
Range Pain 0-10, 0: No pain, 10: Worst Pain
Attack Frequencies
时间窗: Post treatment (4 weeks later)
Number of headaches patients suffer in a month.
次要结局
未报告次要终点
研究者
Mustafa Ceylan
Principal İnvastigator
Ataturk University