The Impact of Greater Occipital Nerve and Stellate Ganglion Block Treatments on Sleep in Chronic Headache Management

Trial Title: The Impact of Greater Occipital Nerve and Stellate Ganglion Block Treatments on Sleep in Chronic Headache Management

NCT ID: NCT06646081

Condition: Chronic Headache
Chronic Headache Disorder
Migraine

Conditions: Official terms:
Ganglion Cysts
Headache Disorders
Headache

Conditions: Keywords:
stellate ganglion block
greater occipital nerve block

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Greater Occipital Nerve Block
Description: The patient is placed prone with the head neutral or slightly flexed. After sterile preparation, a high-frequency linear probe is positioned transversely at the upper nuchal line in the occipital region. The Greater Occipital Nerve, exiting from the posterior root of C2, is located near the occipital artery. Using an in-plane technique, a 25-gauge needle is inserted into the fascial plane around the artery. After confirming no intravascular placement by negative aspiration, 5 mL of a mixture of 50 mg lidocaine and isotonic saline is injected. The fascial plane opening confirms the site. The area is dressed, and the patient is monitored for one hour for side effects.
Arm group label: Greater Occipital Nerve Block Group

Intervention type: Procedure
Intervention name: Stellate Ganglion Block
Description: The patient lies supine with a pillow under the shoulders, and the head slightly extended, neck gently turned opposite to the blockade. After sterile preparation, a high-frequency linear probe is placed transversely at the C6 vertebra (Chassaignac's tubercle). Ultrasound identifies the C6 vertebra, Longus colli muscle, carotid artery, and internal jugular vein. The Stellate Ganglion is located within the prevertebral fascia over the Longus colli. Using an in-plane technique, a 25-gauge needle is inserted and advanced into the prevertebral fascial plane. After confirming no intravascular placement by negative aspiration, 5 mL of 50 mg lidocaine and isotonic saline is injected. The fascial plane opening confirms the site. The area is dressed, and the patient is monitored for one hour for side effects.
Arm group label: Stellate Ganglion Block Group

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ankara Etlik City Hospital

Address:
City: Ankara
Zip: 06000
Country: Turkey

Start date: November 15, 2024

Completion date: July 15, 2025

Lead sponsor:
Agency: Ankara Etlik City Hospital
Agency class: Other

Source: Ankara Etlik City Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06646081