Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients
Primary Purpose
Chronic Migraine, Headache
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
USG Guided Greater Occipital Nerve Block
USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine, Headache
Eligibility Criteria
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).
Sites / Locations
- Eskisehir Osmangazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
USG Guided Greater Occipital Nerve Block (GONB)
USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05464212
First Posted
July 5, 2022
Last Updated
July 15, 2022
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT05464212
Brief Title
Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 20, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
USG Guided Greater Occipital Nerve Block (GONB)
Arm Type
Active Comparator
Arm Title
USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency (GONB+PRF)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
USG Guided Greater Occipital Nerve Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
USG Guided Greater Occipital Nerve Block and Pulsed Radiofrequency
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visuel Analog Scale
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskişehir
State/Province
Odunpazari
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients
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