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

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06121037
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Greater Occipital Nerve; Pulsed Radiofrequency	Procedure: proximal ultrasound-guided GON radiofrequency ablation; Procedure: distal ultrasound-guided GON radiofrequency ablation	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach): Randomized Clinical Trial
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Aug 1, 2023
• Actual Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proximal group proximal ultrasound-guided GON radiofrequency ablation	Procedure: proximal ultrasound-guided GON radiofrequency ablation; proximal GON radiofrequency
Experimental: Distal group distal ultrasound-guided GON radiofrequency ablation	Procedure: distal ultrasound-guided GON radiofrequency ablation; distal GON radiofrequency

Outcome Measures

Primary Outcome Measures

1. Numerical rating score [baseline and at follow-up visits (2 weeks.1, 2.3, and 6 months)]

   0-10 scale, with 0 indicating no pain and 10 indicating the worst possible pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut governorate	Assiut		Egypt	715715

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Ghada Mohammed AboelFadl, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT06121037
• Other Study ID Numbers: GON RF
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 8, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Post-Traumatic Headache; Headache

Study Results

No Results Posted as of Nov 8, 2023