Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients

NCT ID: NCT06247592

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-26

Study Completion Date

2024-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Migraine, Headache Block Occipital Neuralgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiofrequency group

Pulse radiofrequency will be applied at 42 degrees for 240 seconds with a channel placed near the greater occipital nerve.

Group Type EXPERIMENTAL

Greater occipital nerve pulse radiofrequency

Intervention Type PROCEDURE

The greater occipital nerve will be blocked with 5 cc 2% prilocaine.

Block group

Nerve blockade will be applied to the greater occipital nerve with 5 cc 2% prilocaine.

Group Type ACTIVE_COMPARATOR

Greater occipital nerve block

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Greater occipital nerve pulse radiofrequency

The greater occipital nerve will be blocked with 5 cc 2% prilocaine.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Esra Ertilav

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esra Ertilav

Role: PRINCIPAL_INVESTIGATOR

Aydin Adnan Menderes University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Esra Ertilav

Aydin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Esra Ertilav, Assoc.Prof.

Role: CONTACT

+905301408950

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Esra ERTİLAV, Assoc. Prof.

Role: primary

+905301408950

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023/03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.