NCT06345326

Brief Summary

The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF)

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

March 27, 2024

Last Update Submit

April 2, 2024

Conditions

Migraine

Keywords

migrainegreater occipital nerve blockpulse radiofrequency

Outcome Measures

Primary Outcomes (1)

  • NRS

    Numeric rating scala

    Before the application then every month following the intervention for 3 months

Secondary Outcomes (2)

  • Complications

    Before the application then every month following the intervention for 3 months

  • the frequency of headhache

    Before the application then every month following the intervention for 3 months

Study Arms (2)

Repeated greater occipital nerve block

EXPERIMENTAL

In this arm, all the participiants will receive ultrasound guided greater occipital nerve block for a week, for 4 weeks with ultrasound guidiance at the level C2

Other: Greater occipital nerve block

Greater occipital nerve pulse radiofrequency

EXPERIMENTAL

In this arm, all the participiants will receive ultrasound guided greater occipital nerve pulse radiofrequency with ultrasound guidiance at the level C2

Other: Greater occipital nerve block

Interventions

Greater occipital nerve blockOTHER

The nerve block will be done by ultrasound guidiance at the C2 level with a 22 gauge 5 cm needle inplane direction. The pulse radiofrequency will be done as defined with a radiofrequency cannula- 5 cm with an active tip of 2mm.

Also known as: Pulse radiofrequency
Greater occipital nerve pulse radiofrequencyRepeated greater occipital nerve block

Eligibility Criteria

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

You may qualify if:

  • ICHD- migraine with minimum 4 attacks
  • no benefit with proflactic therapies

You may not qualify if:

  • primary headhache other than migraine according to ICHD
  • the change of medical teatment of migrane in last 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, 06680, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 3, 2024

Study Start

January 15, 2023

Primary Completion

March 30, 2024

Study Completion

April 30, 2024

Last Updated

April 3, 2024

Record last verified: 2024-03

Locations

TU(1)