Status
Recruiting
Phase
Not applicable
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study 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.
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
Interventions
PROCEDURE
Patients will be positioned in a prone position with their neck slightly flexed. The trapezius , semispinalis, obliqus capitis muscles will be revealed on short-axis view. A 25- or 21 gauge is used, with puncture point 1-1.5 cm away from the ultrasound probe. Under the guidance of the ultrasound, GOB will performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine.
PROCEDURE
Patients are positioned in a lateral position with their necks slightly hyperextended. Assisted by ultrasound imaging equipment the C7 level is confirmed. The thyroid gland, carotid artery, compressible internal jugular vein, vertebral artery, brachial plexus and the oval-shaped structure of the longus collis muscle are revealed on this short-axis view. A 25- or 21 gauge is used and the puncture point is 1-1.5 cm away from the ultrasound probe The tip of the needle reach the surface of the longus collis muscle and the 5 o'clock position of the carotid artery. Under the guidance of the ultrasound, SGB is performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine.
Timeline
First posted
Oct 29, 2024
Study start
Feb 1, 2024
Primary completion
Nov 1, 2024
Study completion
Mar 2025
Results posted
Not reported
Registry updated
Oct 30, 2024
Outcomes
Changes in Headache impact test (HIT-6)
Time frame · 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)
Time frame · 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)
Time frame · 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"
Changes in circulating CGRP level
Time frame · 1 month
Eligibility
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 locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Ain Shams University Hospital
Cairo, Egypt
Publications
No PMID-linked publications were present in this registry snapshot.
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