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

NCT05464212 | Completed

• 1 other identifier: ESOGU-TTANYEL-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

USG Guided Greater Occipital Nerve Block (GONB)

ACTIVE COMPARATOR

Procedure: USG Guided Greater Occipital Nerve Block

USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)

ACTIVE COMPARATOR

Procedure: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency

Interventions

USG Guided Greater Occipital Nerve Block PROCEDURE

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.

USG Guided Greater Occipital Nerve Block (GONB)

USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency PROCEDURE

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.

USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Odunpazari, Turkey (Türkiye)

Location

Related Publications (1)

• Tanyel Saracoglu T, Bilir A, Gulec MS. Effectiveness of combining greater occipital nerve block and pulsed radiofrequency treatment in patients with chronic migraine: a double-blind, randomized controlled trial. Head Face Med. 2024 Sep 11;20(1):48. doi: 10.1186/s13005-024-00449-7.

  PMID: 39256847 DERIVED

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Research Assistant

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 19, 2022
• Study Start: April 1, 2019
• Primary Completion: October 20, 2019
• Study Completion: April 30, 2020
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)