NCT05499689

Brief Summary

The aim of the investigator is to compare the efficacy of greater occipital nerve block and transcutaneous pulsed radiofrequency treatment in migraine.

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 Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 22, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

August 11, 2022

Last Update Submit

February 2, 2023

Conditions

Keywords

Transcutaneous pulsed radiofrequencypulsed radiofrequency treatmentheadacheGON block

Outcome Measures

Primary Outcomes (1)

  • The Migraine Disability Assessment Test

    The MIDAS questionnaire is an important part of a package of educational, investigative, and therapeutic measures, and could play a major role in improving the care of patients with migraine and other types of headache.

    Baseline

Secondary Outcomes (1)

  • Visual analog scale (VAS)

    Baseline, Week 4

Study Arms (2)

GON block group

ACTIVE COMPARATOR

30 patients who underwent greater occipital nerve block

Drug: Bupivacaine Hydrochloride

Transcutaneous pulsed RF group

ACTIVE COMPARATOR

30 patients who underwent greater occipital nerve pulsed radiofrequency

Other: Transcutaneous pulsed radiofrequency qurrent

Interventions

2.5 cc bupivacain injection will be administered by approaching the greater occipital nerve under ultrasound guidance.

GON block group

Pulsed radiofrequency current will be applied through transcutaneous pads adhered over the greater occipital nerve trace on the nape.

Transcutaneous pulsed RF group

Eligibility Criteria

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

You may qualify if:

  • Chronic Migraine

You may not qualify if:

  • Other headaches will not accompany (tension-type headache, cluster...)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Ankara, Altındğ, Turkey (Türkiye)

Location

Related Publications (1)

  • Perdecioglu GRG, Ates MP, Yuruk D, Can E, Yildiz G, Akkaya OT. A new neuromodulation method in chronic migraine; non-invasive pulsed radiofrequency, a single-blinded, randomised, controlled trial. Ir J Med Sci. 2024 Jun;193(3):1487-1493. doi: 10.1007/s11845-023-03598-x. Epub 2023 Dec 26.

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • mehlika panpallı ateş

    Diskapi TRH

    STUDY CHAIR
  • ömer taylan akkaya

    Diskapi TRH

    STUDY DIRECTOR
  • Hüseyin Alp Alptekin

    Diskapi TRH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, medical doctor

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 12, 2022

Study Start

June 22, 2021

Primary Completion

June 22, 2023

Study Completion

August 22, 2023

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations