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

Sponsor

Eskisehir Osmangazi University (Other)

Overall Status

Completed

CT.gov ID

NCT05464212

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Migraine, Headache	Procedure: USG Guided Greater Occipital Nerve Block Procedure: USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Oct 20, 2019

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eskisehir Osmangazi University	Eskişehir	Odunpazari	Turkey

Sponsors and Collaborators

Eskisehir Osmangazi University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Tuba Tanyel, Medical Doctor, Research Assistant, Eskisehir Osmangazi University

ClinicalTrials.gov Identifier:

NCT05464212

Other Study ID Numbers:

ESOGU-TTANYEL-01

First Posted:

Jul 19, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Migraine Disorders

Headache

Study Results

No Results Posted as of Jul 19, 2022