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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06646081
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ankara Etlik City Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Gevher Rabia Genc Perdecioglu
Principal Investigator Affiliation Ankara Etlik City Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Chronic Headache, Chronic Headache Disorder, Migraine
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Greater Occipital Nerve Block Group

Greater Occipital Nerve Block for Chronic Headache

Active Comparator: Stellate Ganglion Block Group

Stellate Ganglion Block for Chronic Headache

Interventions

Procedure: - Greater Occipital Nerve Block

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.

Procedure: - Stellate Ganglion Block

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ankara Etlik City Hospital, Ankara, Etlik, Turkey

Status

Address

Ankara Etlik City Hospital

Ankara, Etlik, 06000

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