Clinical trial NCT06122545: Chronic Migraine Prophylaxis: Ultrasound-Guided Greater Occipital Nerve Block Versus Medical Treatment
Official title: Chronic Migraine Prophylaxis: Comparative Study Between Ultrasound-Guided Greater Occipital Nerve Block and Medical Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Greater Occipital Nerve Block
Medical Treatment
Chronic Migraine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: severity of headache
timeFrame: Follow up after 3 months
Secondary outcomes:
measure: Reduction in headache days per month
timeFrame: Follow up after 3 months
measure: Migraine specific quality of life
timeFrame: Follow up after 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: