Chronic Migraine Prophylaxis: Ultrasound-Guided Greater Occipital Nerve Block Versus Medical Treatment

NCT ID: NCT06122545

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Greater Occipital Nerve Block; Medical Treatment; Chronic Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Greater Occipital Nerve Block

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

Group Type: EXPERIMENTAL

Greater Occipital Nerve Block

Intervention Type: PROCEDURE

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 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

bupivacaine or onabotulinum toxin A injection.

Intervention Type: DRUG

bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.

Medical Treatment

Patients who will receive medical treatment

Group Type: EXPERIMENTAL

Medical Treatment

Intervention Type: OTHER

Patients who will receive medical treatment

Interventions

Greater Occipital Nerve Block

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 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

Intervention Type: PROCEDURE

Medical Treatment

Patients who will receive medical treatment

Intervention Type: OTHER

bupivacaine or onabotulinum toxin A injection.

bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years old.

2. Both sexes.

3. Patients with chronic migraine.

Exclusion Criteria

1. Age less than 18 years.

2. Patients with medication overuse headache.

3. Patients who had used acute pain medications within 24 hours prior to the study visit.

4. History of injury to the area of the GON.

5. Any prior adverse reactions to local anesthetics.

6. Patients with impaired sensation in the occipital area.

7. Any neurological or dermatological disease that may have affected skin sensation, bleeding tendency, any skull defect.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Zakaria Mohamed Elramady

Assistant Lecturer of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sarah Z Elramady, Master

Role: CONTACT

sara.zakria@med.tanta.edu.eg

00201122848960

Facility Contacts

Sarah Z Elramady, Master

Role: primary

sara.zakria@med.tanta.edu.eg

00201122848960

Other Identifiers

35459/4/22

Identifier Type: -

Identifier Source: org_study_id