Individualized Application of Occipital Nerve Pulsed Radiofrequency in Medication Overuse Headache: A Randomized Controlled Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Monthly Headache Days
研究概览
简要总结
This study evaluates a novel treatment approach for medication overuse headache (MOH) using greater occipital nerve pulsed radiofrequency (GONPRF).
Three treatment strategies are compared:
Standard Treatment: Limitation of overused acute headache medications, lifestyle counseling, and continuation of existing preventive medications.
Primary GONPRF: GONPRF administered in addition to standard treatment.
Modified GONPRF: GONPRF administered as a second-line intervention in individuals who do not respond adequately to standard treatment alone.
The study assesses whether GONPRF, when applied early or after an initial period of standard care, reduces monthly headache days more rapidly and effectively than standard treatment alone. Outcomes are evaluated over a 6-month follow-up period using headache diaries and scheduled clinical assessments.
This is a randomized controlled trial designed to systematically evaluate the clinical benefit of GONPRF in patients with medication overuse headache.
详细描述
This is a single-center, prospective, adaptive randomized controlled trial evaluating the efficacy of greater occipital nerve pulsed radiofrequency (GONPRF) in patients with medication overuse headache (MOH). Although occipital nerve blocks have been investigated in MOH, randomized controlled trials evaluating GONPRF in this population are lacking. The study aims to compare different treatment strategies incorporating GONPRF in the management of MOH.
Study Design
The trial employs a two-stage adaptive randomized design.
Stage 1 - Initial Randomization
Patients diagnosed with MOH according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), are randomized in a 2:1 ratio into two groups:
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
盲法说明
This is an open-label study. No participants, care providers, investigators, or outcome assessors are masked.
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 18-65 years
- •Diagnosed with Medication Overuse Headache (MOH) according to ICHD-3 criteria
- •No laboratory evidence of bleeding or clotting disorders
- •No active infection
- •Not pregnant and no suspicion of pregnancy
- •No history of craniocervical surgery that may alter anatomical structures at the intervention site
- •Able to understand the study procedures, provide written informed consent, and comply with treatment
排除标准
- •Changes in preventive treatment for migraine and/or tension-type headache within the last 3 months
- •Severe systemic disease (e.g., uncontrolled diabetes, serious cardiovascular disease, malignancy)
- •Psychiatric disorders (including current antidepressant use or psychiatric follow-up)
- •History of alcohol or substance abuse
- •Pregnancy, breastfeeding, or plans for pregnancy in the next 12 months
- •Concurrent use of other prophylactic headache treatments
研究组 & 干预措施
Arm 1- Standard Treatment (Group A1)
Intervention Name: Standard Care Intervention Type: Other (Behavioral / Educational / Non-drug) Description: Limitation of overused acute headache medications, lifestyle advice (nutrition, hydration, activity, sleep), and continuation of preventive medications. Participants who respond at 1 month continue standard care.
干预措施: Standard care (Other)
Arm 2: Primary GONPRF (Group B)
Intervention Name: Greater Occipital Nerve Pulsed Radiofrequency (GONPRF)
Intervention Type: Procedure
Description: GONPRF applied at C2 under ultrasound guidance in addition to standard care, starting at enrollment. Follow-up at 1, 3, and 6 months.
干预措施: Greater Occipital Nerve Pulsed Radiofrequency (Procedure)
Arm 3: Modified GONPRF (Group A2)
Intervention Name: Greater Occipital Nerve Pulsed Radiofrequency (GONPRF) - Second Line
Intervention Type: Procedure
Description: Participants initially on standard care who do not achieve ≥50% improvement at 1 month receive GONPRF as a second-line intervention, alongside continued standard care, with follow-up at 3 and 6 months.
干预措施: Greater Occipital Nerve Pulsed Radiofrequency (Procedure)
结局指标
主要结局
Change in Monthly Headache Days
时间窗: Baseline to 3 months
Number of headache days per month, defined as days with headache lasting ≥4 hours and/or requiring acute headache treatment, recorded using patient headache diaries. The primary analysis compares the change from baseline to 3 months.
次要结局
- Monthly Headache Days - 1 and 6 Months(Baseline, 1 month, and 6 months)
- Monthly Acute Medication Use Days(Baseline, 1 month, 3 months, and 6 months)
- Headache Pain Intensity (Numeric Rating Scale, NRS)(Baseline, 1 month, 3 months, and 6 months)
- Headache Duration (hours)(Baseline, 1 month, 3 months, and 6 months)
- Headache Impact Test-6 (HIT-6) Score(Baseline, 1 month, 3 months, and 6 months)
- Migraine Disability Assessment (MIDAS) Grade(Baseline, 3 months, and 6 months)
- Global Perceived Effect (GPE) Score(Baseline, 1 month, 3 months, and 6 months)
研究者
Şükriye Dadalı
Pain Medicine (Algology) specialist
Ankara City Hospital Bilkent