Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646081
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
The Impact of Greater Occipital Nerve and Stellate Ganglion Block Treatments on Sleep in Chronic Headache Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Greater Occipital Nerve and Stellate Ganglion Blocks on Sleep Quality in Chronic Headache Patients A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the effect of Greater Occipital Nerve and Stellate Ganglion block treatments on sleep in patients with chronic headaches Patients will be assessed using the Pittsburgh Sleep Quality Index Insomnia Severity Index and Visual Analog Scale at the time of treatment and at 4 and 8 weeks post-procedure The study will compare the sleep improvement effects of both treatments to help guide clinicians in selecting the most effective interventional method Demographic and clinical data will also be collected and analyzed for statistical comparison
Detailed Description:
The aim of this study is to evaluate the effect of Greater Occipital Nerve and Stellate Ganglion blockade treatments used in the treatment of chronic headache on sleep These treatments were administered in two sessions one week apart for chronic headache The goal is to compare the treatments using scales at the time of application and at the fourth and eighth weeks after the last procedure
The improvement effect of Greater Occipital Nerve block on sleep quality scales has recently been reported in several studies in the literature However the efficacy of Stellate Ganglion block a proven method for headache treatment in these areas has not yet been studied and its effect on sleep improvement will be investigated
It is believed that determining the superiority of the interventional methods used on sleep based on scales will assist clinicians in decision-making when performing the procedure
Patients with chronic headache lasting more than 3 months who undergo Greater Occipital Nerve or Stellate Ganglion blockade at the clinic will be evaluated The Pittsburgh Sleep Quality Index and Insomnia Severity Index will be applied immediately after the procedure and at the 4th and 8th weeks following the last procedure The Visual Analog Scale VAS will be obtained from clinic notes for the pre-procedure value and will be repeated at the 4th and 8th weeks post-procedure The administration of scales will be conducted at Etlik City Hospital Algology Clinic Patients will be evaluated either during outpatient follow-up or by phone This study will not include sensitive or vulnerable patient groups Demographic characteristics age gender height weight BMI alcohol and smoking habits comorbidities obesity restless legs psychiatric disorders sleep disorders medications and the scores from the mentioned scales will be recorded and statistically compared
The improvement effect of Greater Occipital Nerve block on sleep quality scales has recently been reported in several studies in the literature However the efficacy of Stellate Ganglion block a proven method for headache treatment in these areas has not yet been studied and its effect on sleep improvement will be investigated
It is believed that determining the superiority of the interventional methods used on sleep based on scales will assist clinicians in decision-making when performing the procedure
Patients with chronic headache lasting more than 3 months who undergo Greater Occipital Nerve or Stellate Ganglion blockade at the clinic will be evaluated The Pittsburgh Sleep Quality Index and Insomnia Severity Index will be applied immediately after the procedure and at the 4th and 8th weeks following the last procedure The Visual Analog Scale VAS will be obtained from clinic notes for the pre-procedure value and will be repeated at the 4th and 8th weeks post-procedure The administration of scales will be conducted at Etlik City Hospital Algology Clinic Patients will be evaluated either during outpatient follow-up or by phone This study will not include sensitive or vulnerable patient groups Demographic characteristics age gender height weight BMI alcohol and smoking habits comorbidities obesity restless legs psychiatric disorders sleep disorders medications and the scores from the mentioned scales will be recorded and statistically compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None