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

NCT06646081 | Not Yet Recruiting

• 1 other identifier: GON block vs Stellate block
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Headache; Chronic Headache Disorder; Migraine

Keywords

stellate ganglion block; greater occipital nerve block

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index is a questionnaire designed to assess sleep quality and disturbances over a one-month period. It consists of 19 self-rated questions and 5 questions rated by a bed partner or roommate (if available), which are not included in the score. The Pittsburgh Sleep Quality Index generates seven component scores, which are combined to produce a global score ranging from 0 to 21, with higher scores indicating worse sleep quality. A score greater than 5 indicates poor sleep quality.assess sleep quality and disturbances over a one-month period.

  Change from baseline to 1st and 2nd month after treatment

• Insomnia Severity Index

  The Insomnia Severity Index is a self-reported questionnaire designed to assess the severity of insomnia symptoms and their impact on daily functioning. The Insomnia Severity Index consists of 7 items that assess the severity of sleep onset, sleep maintenance difficulties, early morning awakenings, satisfaction with sleep, interference with daily functioning, noticeability of impairment attributed to sleep problems, and the level of distress caused by sleep difficulties. The total Insomnia Severity Index score ranges from 0 to 28, with higher scores indicating more severe insomnia.

  Change from baseline to 1st and 2nd month after treatment

Secondary Outcomes (1)

• Numeric Rating Scale

  Change from baseline to 1st and 2nd month after treatment

Study Arms (2)

Greater Occipital Nerve Block Group

ACTIVE COMPARATOR

Greater Occipital Nerve Block for Chronic Headache

Procedure: Greater Occipital Nerve Block

Stellate Ganglion Block Group

ACTIVE COMPARATOR

Stellate Ganglion Block for Chronic Headache

Procedure: Stellate Ganglion Block

Interventions

Greater Occipital Nerve Block PROCEDURE

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.

Greater Occipital Nerve Block Group

Stellate Ganglion Block PROCEDURE

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.

Stellate Ganglion Block Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Etlik, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache Disorders; Migraine Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary

Study Officials

• Gevher Rabia Genc Perdecioglu

  Ankara Etlik City Hospital

  STUDY CHAIR

Central Study Contacts

Ufuk Turan

CONTACT

+905395594772; drufukturan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: November 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

TU (1)