Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients

NCT06247592 | Recruiting

• 1 other identifier: 2023/03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the effect of nerve blockade and radiofrequency treatment applied to the nerve on pain in chronic migraine patients will be investigated. Occipital nerve blockade group (control group): Depending on the location of the pain, blockade will be applied unilaterally or bilaterally with 5 cc of 2% prilocaine for each sıde. Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location with 42 degree, for 240 seconds.

Conditions

Chronic Migraine, Headache; Block; Occipital Neuralgia

Keywords

chronic migraine; greater occipital nerve block; pulse radio frequency; pain management

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  Compare the efficacy of blockade procedure applied to the greater occipital nerve with pulse radiofrequency therapy in terms of pain relief with Visual Analog Scale in chronic migraine patients.The visual analog scale (VAS) is numbered from 0 to 10. 10 is the most severe pain 0: no pain at all

  1 and 3 months

Secondary Outcomes (1)

• Disability, Quality of life

  1 and 3 months

Study Arms (2)

Radiofrequency group

EXPERIMENTAL

Pulse radiofrequency will be applied at 42 degrees for 240 seconds with a channel placed near the greater occipital nerve.

Procedure: Greater occipital nerve pulse radiofrequency

Block group

ACTIVE COMPARATOR

Nerve blockade will be applied to the greater occipital nerve with 5 cc 2% prilocaine.

Procedure: Greater occipital nerve block

Interventions

Greater occipital nerve block PROCEDURE

Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location at 42 degree, for 240 seconds.

Block group

Greater occipital nerve pulse radiofrequency PROCEDURE

The greater occipital nerve will be blocked with 5 cc 2% prilocaine.

Radiofrequency group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 18-60 years of age diagnosed with chronic migraine according to IHS criteria

You may not qualify if:

• Pregnancy
• Major psychiatric disorder
• Bleeding diathesis
• Local infection
• Allergy

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Esra Ertilav

Aydin, 09100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Headache; Bites and Stings; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Esra Ertilav

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Ertilav, Assoc.Prof.

CONTACT

+905301408950; eertilav@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 8, 2024
• Study Start: September 26, 2023
• Primary Completion: March 10, 2024
• Study Completion: April 10, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)