Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Resistant Migraine and Correlation to Calcitonin Gene Related Peptide

Not Applicable

Recruiting

• Conditions: Migraine

• Registration Number: NCT06662461
• Lead Sponsor: Ain Shams University

Brief Summary

To investigate the efficacy of Ultrasound guided Stellate Ganglion block in chronic resistant migraine patients in comparison to Greater Occipital Nerve Block correlating its effect to serum CGRP level.

Detailed Description

40 Patients diagnosed with Chronic resistant migraine to 2 anti-migraine drugs for 3 months will be evaluated for inclusion and exclusion. Eligible patients with resistance or intolerability to 2 drugs or more will be classified into two groups by using simple randomization methods through Using a computer-generated random number sequence.

Each group will contain 20 patients one group will undergo ultrasound guided bilateral Greater Occipital nerve Block and the other group will undergo ultrasound guided bilateral Stellate Ganglion Block

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-29
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-30
• Primary Completion: 2024-11-01
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Individuals diagnosed with chronic resistant migraine after using or intolerability to 2 or more of anti-migraine drugs for at least 3 months

Exclusion Criteria

• Patients with a space-occupying lesion.
• Coagulation disorders.
• Systemic or local infection and drug allergies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Headache impact test (HIT-6)	3 months	Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
changes in Migraine disability assessment test (MIDAS)	3 months	The MIDAS questionnaire is based on five disability questions that focus on lost time in three domains: school work or work for pay; household work or chores; and family, social, and leisure activities. The scoring is: 0-5: little or no disability 6-10: mild disability 11-20: moderate disability 21+: severe disability
changes in Numeric Rating Scale (NRS)	3 months	a score used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Secondary Outcome Measures

Name	Time	Method
Changes in circulating CGRP level	1 month

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt