Clinical trial NCT06646081: The Impact of Greater Occipital Nerve and Stellate Ganglion Block Treatments on Sleep in Chronic Headache Management
Official title: The Effects of Greater Occipital Nerve and Stellate Ganglion Blocks on Sleep Quality in Chronic Headache Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Headache
Chronic Headache Disorder
Migraine
Keywords: stellate ganglion block
greater occipital nerve block
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Chronic headache unresponsive to conservative treatment
* Male and female population aged 18-50
* No prior interventional procedures during the treatment process

Exclusion Criteria:

* Coagulation disorders
* Infections at the procedure site
* Allergy to local anesthesia
* Socio-cultural inadequacy
* Mental retardation
* Pregnancy
* Previous interventional procedures
* Patient refusal of interventional procedure
* Use of any sleep-improving medication within the last month

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline to 1st and 2nd month after treatment
measure: Insomnia Severity Index
timeFrame: Change from baseline to 1st and 2nd month after treatment
Secondary outcomes:
measure: Numeric Rating Scale
timeFrame: Change from baseline to 1st and 2nd month after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Etlik
Study officials:
affiliation: Ankara Etlik City Hospital
name: Gevher Rabia Genc Perdecioglu
role: STUDY_CHAIR
References: