Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458179
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief Title:
Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve in Primary Occipital Neuralgia
Sponsor:
Mersin Training and Research Hospital
Organization:
Mersin Training and Research Hospital
Study Overview
Official Title:
Retrospective Cohort Study For One Year Follow-up Ultrasound Guided Radiofrequency Ablation of Proximal Greater Occipital Nerve is Effective
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGON-RFA
Brief Summary:
The International Headache Society IHS defines occipital neuralgia as a unilateral or bilateral paroxysmal shooting or stabbing pain in the posterior region of the scalp in the distribution of the greater occipital nerve GON lesser occipital nerve LON or third occipital nerve TON The condition is occasionally accompanied by diminished sensation or dysesthesia in the affected area and is frequently associated with tenderness over the involved nerves The majority of cases with occipital neuralgia are idiopathic with no clearly defined anatomical cause First conservative treatment approaches including medication and physical therapy are frequently used When conservative measures fail to alleviate occipital neuralgia interventional treatments such as local occipital nerve anesthetic and corticosteroid infiltration botulinum toxin A injection occipital nerve subcutaneous neurostimulation or occipital nerve radifrequency treatment may be used
Detailed Description:
Radiofrequency ablation RFA is a thermal ablative procedure commonly used to treat chronic neurogenic pain by targeting peripheral nerves or dorsal root ganglion by destructing the tissue at a temperature ranging beteen 60-80 C The pain is interrupted by destructing the nerve with Wallerian dejeneration The pain interruption period is longer and stronger than pulsed radiofrequency GON is a pure sensory nerve RFA may be an alternative therapy option for occipital neuralgia By ultrasound US guidance at C2 level GON lies between semispinalis capitis muscle and inferior oblique muscle The GON is well identified here and can be easily targeted rather than trying to identify the terminal subcutaneous branches at the nuchal line Diagnostic blockade was administered to patients who did not respond to conventional therapy If the response to diagnostic blockade was greater than 50 RFA was instituted one week later Patients headache intensity was measured using the Numeric Rating Scale-11 Pain Score NRS at each appointment pre-intervention 1-3-6 and 12 months post-intervention At each appointment an evaluation of headache disability was conducted using the Headache Impact Test Hit-6 and the number of headache days per month The efficacy of the treatment was defined as NRS4 at the twelveth month During the initial evaluation patients demographic details and headache symptoms were thoroughly questioned In accordance with the Turkish National Headache and Pain Research Associations recommendation patients were asked to keep up headache diaries for the duration of the treatment and all subsequent appointments The headache intensity headache disability and the number of headache days in a month as well as the use of rescue medication including NSAIDs and paracethamol were determined from the diaries and discussed with the patient at each session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None