Comparison of the Efficacy of Unilateral and Bilateral Proximal Greater Occipital Nerve Pulsed Radiofrequency in the Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Change in monthly headache days
研究概览
简要总结
This study is designed to compare the clinical effectiveness of unilateral and bilateral Greater Occipital Nerve Pulsed Radiofrequency (GON-PRF) treatment at the C2 level in patients with migraine. The procedure will be guided by ultrasound and will focus on evaluating how each technique affects migraine symptoms.
The main goal of this study is to assess the impact of both unilateral and bilateral GON-PRF treatments on migraine relief. Additionally, the secondary objectives of this study include evaluating the effects of these treatments on migraine-related disability and comparing any potential side effects or complications that may occur during the treatments.
This research will help us understand which technique may be more effective and provide more information on the safety of these treatments.
详细描述
Migraine is a common neurological disorder that significantly affects quality of life and socio-economic functioning. In patients with headaches resistant to conservative pharmacological treatment, peripheral nerve interventions, particularly greater occipital nerve (GON) block, are frequently used. GON block can reduce the frequency and intensity of migraine attacks and may decrease the need for systemic medications. However, the duration of benefit following GON block with local anesthetics and steroids is often limited to several weeks or months.
To prolong the therapeutic effect of peripheral nerve interventions, pulsed radiofrequency (PRF) has been introduced. PRF modulates pain transmission by generating an electrical field around the targeted nerve without causing structural nerve damage. Greater occipital nerve pulsed radiofrequency (GON PRF) has been reported to be both effective and safe in the treatment of migraine and is widely used in pain management practice.
GON block and GON PRF procedures can be performed using anatomical landmark techniques or under ultrasound guidance. Two ultrasound-guided approaches have been described: a proximal technique targeting the nerve at the C2 vertebral level and a distal technique targeting the superior nuchal line. The proximal (C2) approach has been shown to provide effective results in migraine treatment.
Although the exact mechanism of long-term headache relief following peripheral nerve interventions remains unclear, it is believed to involve central pain modulation. The upper cervical nerve roots are anatomically and functionally connected with trigeminal pathways, converging within the trigeminocervical complex. Neurophysiological findings suggest that unilateral nerve interventions may produce bilateral inhibitory effects through modulation of second-order neuronal transmission.
Retrospective clinical observations indicate that unilateral GON interventions may provide similar reductions in headache frequency, severity, and duration compared to bilateral applications, with potentially fewer side effects. However, there is currently no prospective study directly comparing unilateral and bilateral GON PRF in patients with migraine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Followed at the Algology outpatient clinic of Ankara Bilkent City Hospital
- •Diagnosis of episodic migraine (≥5 attacks per month) or chronic migraine according to ICHD-3 criteria
- •Inadequate response to migraine preventive medications
- •Not currently using preventive migraine medication OR no change in medication and/or dosage within the last 3 months
- •No bleeding or coagulation disorders
- •No active infection
- •Not pregnant and not suspected of pregnancy
- •No history of craniocervical surgery affecting the intervention area
- •Able to understand the study and provide written informed consent
- •Able to comply with study procedures and follow-up
排除标准
- •Diagnosis of primary headache other than migraine according to ICHD-3 criteria
- •Fewer than 5 migraine attacks per month
- •Headache secondary to comorbid conditions (e.g., uncontrolled hypertension, intracranial lesions)
- •Interventional migraine treatment within 3 months prior to GON-PRF
- •Botulinum toxin injection within 3 months prior to GON-PRF
- •Non-pharmacological migraine treatment (e.g., acupuncture, physical therapy, ozone therapy, cognitive behavioral therapy) within 3 months prior to GON-PRF
- •Withdrawal of consent at any stage of the study
- •Failure to attend follow-up visits
- •Development of any condition that meets exclusion criteria during the study
研究组 & 干预措施
Unilateral GON PRF Treatment
This arm involves applying unilateral greater occipital nerve pulsed radiofrequency (GON PRF) at the C2 level using ultrasound guidance. The procedure is performed on one side of the head (unilateral).
干预措施: Greater Occipital Nerve Pulsed Radiofrequency (Unilateral) (Other)
Bilateral GON PRF Treatment
This arm involves applying bilateral greater occipital nerve pulsed radiofrequency (GON PRF) at the C2 level using ultrasound guidance. The procedure is performed on both sides of the head (bilateral).
干预措施: Bilateral GON PRF Treatment: (Other)
结局指标
主要结局
Change in monthly headache days
时间窗: Baseline and 6 months after treatment
Description: Monthly headache days defined as calendar days with headache lasting ≥4 hours with at least moderate intensity, or any headache requiring acute migraine medication use. Note: Primary outcome definition updated from VAS score to monthly headache days per the study protocol. VAS scores are retained as secondary outcomes.
次要结局
- Global Perceived Effect (GPE)(1 month, 3 months, and 6 months after treatment)
- Acute Medication Use Days(Baseline and monthly follow-up for 6 months)
- Change in Headache Intensity (VAS)(Baseline, 1 month, 3 months, and 6 months after treatment)
- Change in MIDAS Score(Baseline, 3 months, and 6 months after treatment)
- Change in Headache Impact Test-6 (HIT-6)Score(Baseline, 3 months, and 6 months after treatment)
- Adverse Events(Up to 6 months after treatment)
研究者
Ülkü Sabuncu
Assoc. Prof. Dr.
Ankara City Hospital Bilkent