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

Not Applicable

Completed

• Conditions: Chronic Migraine, Headache
• Interventions: Procedure: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency; Procedure: USG Guided Greater Occipital Nerve Block

• Registration Number: NCT05464212
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-10-20
• Study Completion: 2020-04-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)	USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency	-
USG Guided Greater Occipital Nerve Block (GONB)	USG Guided Greater Occipital Nerve Block	-

Primary Outcome Measures

Name	Time	Method
Visuel Analog Scale	6 months	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

Trial Locations

Locations (1)

Eskisehir Osmangazi University; 🇹🇷 Eskişehir, Odunpazari, Turkey