Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients

Not Applicable

Recruiting

• Conditions: Chronic Migraine, Headache; Occipital Neuralgia; Block
• Interventions: Procedure: Greater occipital nerve pulse radiofrequency; Procedure: Greater occipital nerve block

• Registration Number: NCT06247592
• Lead Sponsor: Aydin Adnan Menderes University

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.

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.

Study Timeline

• Study Start: 2023-09-26
• Study First Submitted: 2024-01-05
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-03-10
• Study Completion: 2024-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Radiofrequency group	Greater occipital nerve pulse radiofrequency	Pulse radiofrequency will be applied at 42 degrees for 240 seconds with a channel placed near the greater occipital nerve.
Block group	Greater occipital nerve block	Nerve blockade will be applied to the greater occipital nerve with 5 cc 2% prilocaine.

Primary Outcome Measures

Name	Time	Method
Pain Relief	1 and 3 months	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

Secondary Outcome Measures

Name	Time	Method
Disability, Quality of life	1 and 3 months	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

Trial Locations

Locations (1)

Esra Ertilav; 🇹🇷 Aydın, Turkey