Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients

Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients: A Randomized Controlled Double-Blind Study

Chronic migraine (CM) is related to headache-related disability and reduced quality of life. Therefore, patients with CM require preventive treatment. The aim of this double-blind, comparative-effectiveness study was to compare ultrasound-guided great occipital nerve (GON) block and pulsed radiofrequency (PRF) application in CM patients.

The study consisted of 2 groups: GON block (group GONB) and GON block + pulsed RF (group GONB+PRF). Each group had 16 patients. Ultrasound-guided GONB was performed to locate the nerve more accurately. With 0.5 Hz sensorial stimulation, a 5-cm-long radiofrequency needle was advanced under ultrasound guidance in both groups. GON block was performed in all patients by administering 5mg bupivacaine through a PRF needle. After the GON block, the PRF neuromodulation was applied at 42 degrees for 4 minutes in the GONB-PRF group. In the GONB group, no pulse was given. The patients were examined for follow-ups at the 1st, 2nd, 3rd, and 6th months after the procedure. The severity and the number of migraine attacks, and the number of analgesic drugs were noted.

Study Overview

• Status: Completed
• Conditions: Chronic Migraine, Headache
• Intervention / Treatment: Procedure: USG Guided Greater Occipital Nerve Block; Procedure: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Odunpazari
    • Eskişehir, Odunpazari, Turkey
      • Eskisehir Osmangazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-65;
• ICHD-3 defined chronic migraine

Exclusion Criteria:

• Patients who had been started on an effective preventive medication within the past three months;
• Medication-overuse headache;
• Treatment with peripheral nerve blocks, trigger point injections or botulinum toxin injections within the past three months;
• Known allergic reaction to local anaesthetics;
• Pregnancy or nursing;
• History of another headaches;
• History of chronic medical conditions (e.g. cardiovascular, hepatic, renal, endocrine);
• History of other chronic pain syndromes (e.g. low back pain and fibromyalgia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: USG Guided Greater Occipital Nerve Block (GONB)	Procedure: USG Guided Greater Occipital Nerve Block; With 0.5 Hz sensorial stimulation, a 5-cm-long radiofrequency needle with a 0.5 cm active tip was advanced under ultrasound guidance in both pulsed PRF and nerve block groups. USG probe was located to medial one-third of the superior nuchal line between the occipital tubercle and mastoid process under sterile conditions. Finally, the placement of the needle was verified by Doppler imaging of the occipital artery. A 0.3-0.5 Hz sensory stimulus was given with the RF device, and the paresthesia sensation in the patient's occipital nerve dermatome was questioned, and location verification was performed. Then, GON block was performed in all patients by administering 5mg bupivacaine through a PRF needle. After the GON block, the PRF neuromodulation was applied at 42 degrees for 4 minutes in the GONB-PRF group. In the GONB group, the PRF generator was set for 4 minutes, and the time was waited, but no pulse was given.
Active Comparator: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)	Procedure: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency; With 0.5 Hz sensorial stimulation, a 5-cm-long radiofrequency needle with a 0.5 cm active tip was advanced under ultrasound guidance in both pulsed PRF and nerve block groups. USG probe was located to medial one-third of the superior nuchal line between the occipital tubercle and mastoid process under sterile conditions. Finally, the placement of the needle was verified by Doppler imaging of the occipital artery. A 0.3-0.5 Hz sensory stimulus was given with the RF device, and the paresthesia sensation in the patient's occipital nerve dermatome was questioned, and location verification was performed. Then, GON block was performed in all patients by administering 5mg bupivacaine through a PRF needle. After the GON block, the PRF neuromodulation was applied at 42 degrees for 4 minutes in the GONB-PRF group. In the GONB group, the PRF generator was set for 4 minutes, and the time was waited, but no pulse was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visuel Analog Scale	The lowest score on the visual analog scale is 0 and the highest score is 10. 10 indicates very severe pain, 0 indicates no pain	6 months

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 20, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: ESOGU-TTANYEL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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