Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients

Block Clinical Trial

Official title:

Comparison of Greater Occipital Nerve Block and Pulse Radiofrequency in Patients With Chronic Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247592
• Other study ID #: 2023/03
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: April 10, 2024

Study information

• Verified date: February 2024
• Source: Aydin Adnan Menderes University
• Contact: Esra Ertilav, Assoc.Prof.
• Phone: +905301408950
• Email: eertilav[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 10, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients between 18-60 years of age diagnosed with chronic migraine according to IHS criteria

Exclusion Criteria:

• Pregnancy

• Major psychiatric disorder

• Bleeding diathesis

• Local infection

• Allergy

Related Conditions & MeSH terms

• Block
• Chronic Migraine, Headache
• Headache
• Migraine Disorders
• Neuralgia
• Occipital Neuralgia

Intervention

Procedure:
• Greater occipital nerve block
Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location at 42 degree, for 240 seconds.
• Greater occipital nerve pulse radiofrequency
The greater occipital nerve will be blocked with 5 cc 2% prilocaine.

Locations

Country	Name	City	State
Turkey	Esra Ertilav	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief	Compare the efficacy of blockade procedure applied to the greater occipital nerve with pulse radiofrequency therapy in terms of pain relief with Visual Analog Scale in chronic migraine patients.The visual analog scale (VAS) is numbered from 0 to 10. 10 is the most severe pain 0: no pain at all	1 and 3 months
Secondary	Disability, Quality of life	Compare the efficacy of occipital nerve block with pulse radiofrequency therapy in terms of disability and quality of life with MIDAS (Migraine Disability Assessment) questionnaire win chronic migraine patients. The MIDAS classification is numbered from 0 to 4. 4 means severe disability 0: no disability at all	1 and 3 months