Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients

Comparison of Greater Occipital Nerve Block and Pulse Radiofrequency in Patients With Chronic Migraine

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.

Study Overview

• Status: Recruiting
• Conditions: Block; Chronic Migraine, Headache; Occipital Neuralgia
• Intervention / Treatment: Procedure: Greater occipital nerve pulse radiofrequency; Procedure: Greater occipital nerve block

Detailed Description

Patients between the ages of 18-60 years, who were resistant to medical treatment and diagnosed with chronic migraine according to ICHD-3 beta criteria (migraine pain for more than 15 days in the last 3 months) who applied to the Neurology and Algology outpatient clinic were included in the study.

All procedures were performed with the patient in the prone position, using anatomical landmarks in the target areas. For Gon Blockade, the target point for the greater occipital nerve was identified along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and one-third of the distance medial to the artery at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, bone contact was obtained using a 25-gauge needle. For Pulse Radiofrequency, the target point for the greater occipital nerve was determined as one third of the distance medial to the artery along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, a 5 cm long 20 gauge radiofrequency needle with a 5 mm active tip was inserted close to the targeted nerve. Sensory and motor electrical stimulation was performed to elicit a compatible paresthesia response in the occipital distribution. Pulsed radiofrequency was applied at 42 degrees C for 240 seconds. Patients were observed after the procedure. Patients were observed before and after the procedure.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Ertilav, Assoc.Prof.; Phone Number: +905301408950; Email: eertilav@gmail.com

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Recruiting
    • Esra Ertilav
    • Contact: Esra ERTİLAV, Assoc. Prof.; Phone Number: +905301408950; Email: eertilav@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency group; 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; The greater occipital nerve will be blocked with 5 cc 2% prilocaine.
Active Comparator: Block group; Nerve blockade will be applied to the greater occipital nerve with 5 cc 2% prilocaine.	Procedure: Greater occipital nerve block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability, Quality of life	Compare the efficacy of occipital nerve block with pulse radiofrequency therapy in terms of disability and quality of life with MIDAS (Migraine Disability Assessment) questionnaire win chronic migraine patients. The MIDAS classification is numbered from 0 to 4. 4 means severe disability 0: no disability at all	1 and 3 months

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Esra Ertilav, Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): March 10, 2024
• Study Completion (Estimated): April 10, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: chronic migraine; pain management; greater occipital nerve block; pulse radio frequency
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Neuralgia; Migraine Disorders; Headache
• Other Study ID Numbers: 2023/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No