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临床试验/NCT06122545
NCT06122545招募中不适用

Chronic Migraine Prophylaxis: Comparative Study Between Ultrasound-Guided Greater Occipital Nerve Block and Medical Treatment

Tanta University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
severity of headache

研究概览

简要总结

The aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine.

详细描述

Primary headache disorders, particularly migraine and tension-type headache (TTH) are common worldwide and commonly result in widespread and substantial disability. Chronic migraine (CM) is defined as "headache occurring on 15 or more days per month for more than 3 months which has the features of migraine headache on at least 8 days per month".

The prevalence of CM in the general population is about 2%. It negatively affects emotional and family relationships, education, economic status, and general health. Migraine headaches might become quite severe and incapacitating for patients and management can be challenging even in experienced clinics.

Prophylactic interventions may include pharmacotherapy, behavioral therapy, physical therapy and other strategies. Management often requires the simultaneous use of these different therapeutic modalities. Once the headaches become refractory to conventional pharmacologic management minimally invasive techniques such as peripheral nerve blocks are feasible for pain relief and help to decrease the frequency of the attacks.

Preventive medications for chronic migraine treatment are less well studied than they are for episodic migraine. In addition, some trials evaluating treatment of chronic migraine are limited by one or more methodologic problems, such as small size, concomitant use of other prophylactic medications and/or lack of a specific headache diagnosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Age > 18 years old.
  • Both sexes.
  • Patients with chronic migraine.

排除标准

  • Age less than 18 years.
  • Patients with medication overuse headache.
  • Patients who had used acute pain medications within 24 hours prior to the study visit.
  • History of injury to the area of the GON.
  • Any prior adverse reactions to local anesthetics.
  • Patients with impaired sensation in the occipital area.
  • Any neurological or dermatological disease that may have affected skin sensation, bleeding tendency, any skull defect.

研究组 & 干预措施

Greater Occipital Nerve Block

Experimental

Patients will receive greater occipital nerve block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.

Ultrasound-guided Greater Occipital Nerve Block (GONB) will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery

干预措施: Greater Occipital Nerve Block (Procedure)

Greater Occipital Nerve Block

Experimental

Patients will receive greater occipital nerve block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.

Ultrasound-guided Greater Occipital Nerve Block (GONB) will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery

干预措施: bupivacaine or onabotulinum toxin A injection. (Drug)

Medical Treatment

Experimental

Patients who will receive medical treatment

干预措施: Medical Treatment (Other)

结局指标

主要结局

severity of headache

时间窗: Follow up after 3 months

severity of headache will be assessed by the total Migraine Disability Assessment (MIDAS) score used to define four grades of migraine-related disability with grade I for "little or no disability" (0-5); grade II for "mild disability" (6-10); grade III for "moderate disability" (11-20); and grade IV for "severe disability" (≥ 21).

次要结局

  • Reduction in headache days per month(Follow up after 3 months)
  • Migraine specific quality of life(Follow up after 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Zakaria Mohamed Elramady

Assistant Lecturer of Neurology

Tanta University

研究点 (1)

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