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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Medical Treatment | Experimental | Patients who will receive medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Greater Occipital Nerve Block | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Migraine specific quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Z Elramady, Master | Contact | 00201122848960 | sara.zakria@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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|
| Medical Treatment | Other | Patients who will receive medical treatment |
|
| bupivacaine or onabotulinum toxin A injection. | Drug | bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection. |
|
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 |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| C000629279 | onabotulinum toxin A |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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