Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach)
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedNovember 8, 2023
November 1, 2023
1.6 years
November 2, 2023
November 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Proximal group
EXPERIMENTALproximal ultrasound-guided GON radiofrequency ablation
Distal group
EXPERIMENTALdistal ultrasound-guided GON radiofrequency ablation
Interventions
proximal GON radiofrequency
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous neurosurgical procedures for headache management.
- Patients with contraindications for the RF technique
- Pregnancy or lactation
- History of psychiatric disorders or substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut governorate
Asyut, 715715, Egypt
Related 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.
PMID: 35075408BACKGROUNDCohen 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.
PMID: 26447705BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 7, 2023
Study Start
January 1, 2022
Primary Completion
August 1, 2023
Study Completion
September 1, 2023
Last Updated
November 8, 2023
Record last verified: 2023-11