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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Migraine, Headache

Intervention / Treatment
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* Procedure: USG Guided Greater Occipital Nerve Block
* Procedure: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: USG Guided Greater Occipital Nerve Block (GONB)<br> | Procedure: USG Guided Greater Occipital Nerve Block<br>* 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.<br>|
| Active Comparator: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)<br> | Procedure: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency<br>* 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.<br>|

What is the study measuring?
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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 |