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

NCT ID: NCT06121037

Last Updated: 2023-11-08

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-09-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Greater Occipital Nerve Pulsed Radiofrequency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Proximal group

proximal ultrasound-guided GON radiofrequency ablation

Group Type EXPERIMENTAL

proximal ultrasound-guided GON radiofrequency ablation

Intervention Type PROCEDURE

proximal GON radiofrequency

Distal group

distal ultrasound-guided GON radiofrequency ablation

Group Type EXPERIMENTAL

distal ultrasound-guided GON radiofrequency ablation

Intervention Type PROCEDURE

distal GON radiofrequency

Interventions

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proximal ultrasound-guided GON radiofrequency ablation

proximal GON radiofrequency

Intervention Type PROCEDURE

distal ultrasound-guided GON radiofrequency ablation

distal GON radiofrequency

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 35075408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26447705 (View on PubMed)

Other Identifiers

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GON RF

Identifier Type: -

Identifier Source: org_study_id

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