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

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122545
• Other study ID #: 35459/4/22
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: Sarah Z Elramady, Master
• Phone: 00201122848960
• Email: sara.zakria[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Medical Treatment
• Migraine Disorders

Intervention

Procedure:
• 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

Other:
• Medical Treatment
Patients who will receive medical treatment

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of headache	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).	Follow up after 3 months
Secondary	Reduction in headache days per month	Reduction in headache days per month will be assessed by total Headache Impact Test 6 (HIT 6) score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.	Follow up after 3 months
Secondary	Migraine specific quality of life	The total Migraine Disability Assessment (MIDAS) score range from 0 to 270 with the following disability classification criteria: (1) 0 to 5: slight or no disability, (2) 6 to 10: low levels of disability, (3) 11 to 20: moderate disability, and (4) 21 or above: severe disability.	Follow up after 3 months