Amitriptyline vs GON and SON Blocks in Migraine

Not Applicable

Completed

• Conditions: Headache; Migraine
• Interventions: Drug: Lidocaine 1% Injectable Solution; Drug: Amitriptyline

• Registration Number: NCT04750967
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Brief Summary

Comparison of efficacy and safety of amitriptyline and nerve blocks

Detailed Description

This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Study Start: 2021-04-03
• Primary Completion: 2022-01-01
• Study Completion: 2023-07-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Diagnosed with migraine according to ICHD-3

Exclusion Criteria

• Being over 50 years or under 18 years
• Malignancy and other systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Lidocaine 1% Injectable Solution	Greater occipital nerve and supraorbital nerve block with 1% lidocaine once a week for first four weeks then once a month for 5 months
Control	Amitriptyline	Amitriptyline 25 mg daily for 6 months

Primary Outcome Measures

Name	Time	Method
Number of Participants with 50% Reduction of Headache Frequency	6 months	Monthly headache frequency will be followed

Secondary Outcome Measures

Name	Time	Method
Side effects	6 months	Major and minor side effects will be followed

Trial Locations

Locations (1)

Cem Bölük; 🇹🇷 Istanbul, Fatih, Turkey