Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach)

Pulsed Radiofrequency Clinical Trial

Official title:

Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach): Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121037
• Other study ID #: GON RF
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. Both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis

Description:

Traditional treatment approaches for these headaches often include pharmacological interventions, but in cases of refractory or inadequate response, interventional techniques targeting the greater occipital nerve (GON) have gained attention. Radiofrequency ablation (RFA) has gained recognition as a potential therapeutic option for patients with refractory combined migraine and cervicogenic headaches. The proximal and distal ultrasound-guided approaches are widely utilized for GON RFA. These approaches aim to disrupt pain signals transmitted by the GON and provide relief of pain for these headache disorders

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with combined migraine and cervicogenic headache according to The International Classification of Headache Disorders (ICHD)
• Age between 18 and 65 years.
• Willingness to participate and provide informed consent

Exclusion Criteria:

• Previous neurosurgical procedures for headache management.
• Patients with contraindications for the RF technique
• Pregnancy or lactation
• History of psychiatric disorders or substance abuse

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache
• Pulsed Radiofrequency

Intervention

Procedure:
• proximal ultrasound-guided GON radiofrequency ablation
proximal GON radiofrequency
• distal ultrasound-guided GON radiofrequency ablation
distal GON radiofrequency

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Batistaki C, Madi AI, Karakosta A, Kostopanagiotou G, Arvaniti C. Pulsed Radiofrequency of the Occipital Nerves: Results of a Standardized Protocol on Chronic Headache Management. Anesth Pain Med. 2021 Oct 6;11(5):e112235. doi: 10.5812/aapm.112235. eCollection 2021 Oct. — View Citation

Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating score	0-10 scale, with 0 indicating no pain and 10 indicating the worst possible pain.	baseline and at follow-up visits (2 weeks.1, 2.3, and 6 months)