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

NCT06662461 | Recruiting DMC

• 1 other identifier: FMASU MD14/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

occipital nerve block; stellate ganglion block; migraine

Outcome Measures

Primary Outcomes (3)

• Changes in Headache impact test (HIT-6)

  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.

  3 months

• changes in Migraine disability assessment test (MIDAS)

  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

  3 months

• changes in Numeric Rating Scale (NRS)

  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"

  3 months

Secondary Outcomes (1)

• Changes in circulating CGRP level

  1 month

Study Arms (2)

Ultrasound guided bilateral Greater Occipital nerve Block

ACTIVE COMPARATOR

Procedure: ultrasound guided Greater occipital nerve block

Ultrasound guided bilateral Stellate Ganglion Block

ACTIVE COMPARATOR

Procedure: Ultrasound guided Stellate ganglion block

Interventions

ultrasound guided Greater occipital nerve block 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.

Ultrasound guided bilateral Greater Occipital nerve Block

Ultrasound guided Stellate ganglion block 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.

Ultrasound guided bilateral Stellate Ganglion Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead
• Ahmed Mohamed ElSadek: collaborator
• Sherien Mohamed Farag: collaborator
• Noha Lotfy Soliman: collaborator
• Mohamed Amir Tork: collaborator
• Ahmed Mohamed Abdelfattah Sharawy: collaborator

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Mai Fathy Ass.Prof.Mai Fathy

CONTACT

+2001023868846; maifathy@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: February 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: March 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

EG (1)