NCT05888298

Brief Summary

Greater occipital nerve pulsed radiofrequency therapy is used in the treatment of migraine. This method is applied at the level of the proximal c2 vertebra and by approaching the nerve from the distal 1/3 medial of the occipital protuberant. The investigators aimed to compare the effectiveness of these two methods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

2 active sites

Status
unknown

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, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

February 10, 2023

Last Update Submit

December 21, 2023

Conditions

Migraine DisordersHeadache Migraine Chronic

Keywords

greater occipital nerve blockradiofrequency

Outcome Measures

Primary Outcomes (2)

  • The MIDAS (Migraine Disability Assessment) questionnaire

    The MIDAS (Migraine Disability Assessment) questionnaire was put together to help you measure the impact the headaches. The information on this questionnaire is also helpful the primary care provider to determine the level of pain and disability caused by your headaches.

    Change from Baseline MIDAS at 3 months

  • VAS Visual analog scale

    Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

    Change from Baseline MIDAS at 3 months

Study Arms (2)

Proximal block

ACTIVE COMPARATOR

GON block is performed at C2 vertebra level

Procedure: Greater occipital nerve radiofrequency

Distal block

OTHER

GON block is performed at occipital protuberence

Procedure: Greater occipital nerve radiofrequency

Interventions

Greater occipital nerve radiofrequencyPROCEDURE

Greater nerve block and radiofrequency will be performed at the C2 vertebra level or occipital protuberance

Distal blockProximal block

Eligibility Criteria

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

You may qualify if:

  • Primary migraine hedache, first interventional treatment for headache

You may not qualify if:

  • Preganancy, malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Dişkapi Reserch and Education Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Damla Yuruk

    Diskapi TRH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

February 10, 2023

First Posted

June 5, 2023

Study Start

September 1, 2022

Primary Completion

December 22, 2023

Study Completion

December 28, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations

TU(2)