An interventional study of Greater Occipital Nerve Block and Stellate Ganglion Block in Chronic Headache, Chronic Headache Disorder and Migraine, sponsored by Ankara Etlik City Hospital. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 86 is close to the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.
Compared within Migraine Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Headache Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Greater Occipital Nerve Block for Chronic Headache
Procedure: Greater Occipital Nerve Block
Stellate Ganglion Block for Chronic Headache
Procedure: Stellate Ganglion 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.
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.
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.
Time frame: 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.
Time frame: Change from baseline to 1st and 2nd month after treatment
Numeric Rating Scale
Numeric Rating Scale is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Time frame: Change from baseline to 1st and 2nd month after treatment
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