NCT03435185

Brief Summary

The investigators aimed to evaluate the efficacy of greater occipital nerve and supraorbital nerve blockade with local anesthetics for the preventive treatment of migraine without aura.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 22, 2019

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

February 8, 2018

Results QC Date

February 20, 2018

Last Update Submit

March 21, 2022

Conditions

Migraine Disorders

Keywords

PainNerve BlocksHeadacheLocal AnaestheticsMigraine

Outcome Measures

Primary Outcomes (2)

  • Change of Frequency of Headache

    Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.

    Patients were followed up from baseline to 2 months after first injection.

  • Change of Severity of Headache

    Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome

    Patients were followed up for 2 months from baseline after first injection.

Study Arms (2)

Blockade Group

ACTIVE COMPARATOR

Lidocaine injections. Procedure. Grater occipital nerve and supraorbital nerve were blocked with %2 lidocaine. These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.

Procedure: Lidocaine injections

Placebo Group

PLACEBO COMPARATOR

Saline injections. Procedure. Grater occipital nerve and supraorbital nerve were injected with saline.These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.

Procedure: Saline injections

Interventions

Lidocaine injectionsPROCEDURE

Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.

Blockade Group
Saline injectionsPROCEDURE

Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lack of benefits 1 year from preventive treatment or intolerance to their treatments.
  • ≥ years old
  • Migraine without aura for more than 1 year, minimum of two or more migraine attacks per month.

You may not qualify if:

  • Patients with any chronic illness, medication overuse headache, a history of cranial and cervical surgery
  • Allergies to local anesthetics
  • Hemorrhagic diathesis
  • Alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tang Y, Kang J, Zhang Y, Zhang X. Influence of greater occipital nerve block on pain severity in migraine patients: A systematic review and meta-analysis. Am J Emerg Med. 2017 Nov;35(11):1750-1754. doi: 10.1016/j.ajem.2017.08.027. Epub 2017 Aug 14.

    PMID: 28844531BACKGROUND

MeSH Terms

Conditions

Migraine DisordersPainHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Cem Bölük
Organization
University of Health Sciences Dr. Lütfi Kırdar Kartal Training and Research Hospital
cem.boluk@sbu.edu.tr
+902164413900

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 15, 2018

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

March 23, 2022

Results First Posted

July 22, 2019

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share