Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-30 @ 3:39 AM
Study NCT ID:
NCT06247592
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients
Sponsor:
Aydin Adnan Menderes University
Organization:
Study Overview
Official Title:
Comparison of Greater Occipital Nerve Block and Pulse Radiofrequency in Patients With Chronic Migraine
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, the effect of nerve blockade and radiofrequency treatment applied to the nerve on pain in chronic migraine patients will be investigated.
Occipital nerve blockade group (control group): Depending on the location of the pain, blockade will be applied unilaterally or bilaterally with 5 cc of 2% prilocaine for each sıde.
Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location with 42 degree, for 240 seconds.
Occipital nerve blockade group (control group): Depending on the location of the pain, blockade will be applied unilaterally or bilaterally with 5 cc of 2% prilocaine for each sıde.
Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location with 42 degree, for 240 seconds.
Detailed Description:
Patients between the ages of 18-60 years, who were resistant to medical treatment and diagnosed with chronic migraine according to ICHD-3 beta criteria (migraine pain for more than 15 days in the last 3 months) who applied to the Neurology and Algology outpatient clinic were included in the study.
All procedures were performed with the patient in the prone position, using anatomical landmarks in the target areas. For Gon Blockade, the target point for the greater occipital nerve was identified along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and one-third of the distance medial to the artery at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, bone contact was obtained using a 25-gauge needle. For Pulse Radiofrequency, the target point for the greater occipital nerve was determined as one third of the distance medial to the artery along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, a 5 cm long 20 gauge radiofrequency needle with a 5 mm active tip was inserted close to the targeted nerve. Sensory and motor electrical stimulation was performed to elicit a compatible paresthesia response in the occipital distribution. Pulsed radiofrequency was applied at 42 degrees C for 240 seconds. Patients were observed after the procedure. Patients were observed before and after the procedure.
All procedures were performed with the patient in the prone position, using anatomical landmarks in the target areas. For Gon Blockade, the target point for the greater occipital nerve was identified along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and one-third of the distance medial to the artery at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, bone contact was obtained using a 25-gauge needle. For Pulse Radiofrequency, the target point for the greater occipital nerve was determined as one third of the distance medial to the artery along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, a 5 cm long 20 gauge radiofrequency needle with a 5 mm active tip was inserted close to the targeted nerve. Sensory and motor electrical stimulation was performed to elicit a compatible paresthesia response in the occipital distribution. Pulsed radiofrequency was applied at 42 degrees C for 240 seconds. Patients were observed after the procedure. Patients were observed before and after the procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: