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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03435185
Other study ID # 2014/514/85/5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date June 1, 2016

Study information

Verified date March 2022
Source Dr. Lutfi Kirdar Kartal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to GON and SON in the blockade patients. Placebo patients received 2 ml 0.9% saline in the same way. Patients were blinded to kind of injection.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date June 1, 2016
Est. primary completion date June 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Lack of benefits 1 year from preventive treatment or intolerance to their treatments. - 18 = years old - Migraine without aura for more than 1 year, minimum of two or more migraine attacks per month. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
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