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Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up
GON
Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJanuary 23, 2018
January 1, 2018
2 years
October 8, 2015
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
50% decrease in migraine severity
6 months
Study Arms (2)
drug: bupivacaine
PLACEBO COMPARATORPlacebo comparator: bupivacaine first 3 months 0.5% 1 cc bupivacaine diluated with 1.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
placebo
PLACEBO COMPARATORfirst 3 months 2.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
Interventions
Eligibility Criteria
You may qualify if:
- Chronic migraine headache according to International Headache Society Classification Criteria
- Patients who are not using any prophylacting agent
You may not qualify if:
- patients given similar treatments before
- pregnant women
- hereditary diseases causing bleeding
- patients who have intracranial tumor or operation in posterior fossa
- allergic reactions to local anesthetics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bozok Universitylead
Related Publications (1)
Inan LE, Inan N, Karadas O, Gul HL, Erdemoglu AK, Turkel Y, Akyol A. Greater occipital nerve blockade for the treatment of chronic migraine: a randomized, multicenter, double-blind, and placebo-controlled study. Acta Neurol Scand. 2015 Oct;132(4):270-7. doi: 10.1111/ane.12393. Epub 2015 Mar 13.
PMID: 25765043BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Levent E Inan, Prof.
Bozok University Neurology Department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 19, 2015
Study Start
July 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
January 23, 2018
Record last verified: 2018-01