The Effects of Greater Occipital Nerve and Stellate Ganglion Blocks on Sleep Quality in Chronic Headache Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic headache unresponsive to conservative treatment
- •Male and female population aged 18-50
- •No prior interventional procedures during the treatment process
排除标准
- •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
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: Change from baseline to 1st and 2nd month after treatment
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.
Insomnia Severity Index
时间窗: Change from baseline to 1st and 2nd month after treatment
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.
次要结局
- Numeric Rating Scale(Change from baseline to 1st and 2nd month after treatment)
研究者
Ufuk Turan, MD
Principal Investigator
Ankara Etlik City Hospital