Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients
NCT ID: NCT05464212
Last Updated: 2022-07-19
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2019-04-01
2020-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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USG Guided Greater Occipital Nerve Block (GONB)
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.
USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* ICHD-3 defined chronic migraine
Exclusion Criteria
* 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).
18 Years
65 Years
ALL
No
Sponsors
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Eskisehir Osmangazi University
OTHER
Responsible Party
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Tuba Tanyel
Medical Doctor, Research Assistant
Locations
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Eskisehir Osmangazi University
Eskişehir, Odunpazari, Turkey (Türkiye)
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ESOGU-TTANYEL-01
Identifier Type: -
Identifier Source: org_study_id
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