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Clinical Trials/NCT06122545
NCT06122545
Recruiting
Not Applicable

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

Tanta University1 site in 1 country80 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Greater Occipital Nerve Block
Conditions
Greater Occipital Nerve Block
Sponsor
Tanta University
Enrollment
80
Locations
1
Primary Endpoint
severity of headache
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
May 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Zakaria Mohamed Elramady

Assistant Lecturer of Neurology

Tanta University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & 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 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

Intervention: Greater Occipital Nerve Block

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

Intervention: bupivacaine or onabotulinum toxin A injection.

Medical Treatment

Patients who will receive medical treatment

Intervention: Medical Treatment

Outcomes

Primary Outcomes

severity of headache

Time Frame: 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).

Secondary Outcomes

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

Study Sites (1)

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