NCT06583122招募中不适用
Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction pain scores reported using an 11-point numeric rating scale (NRS)
研究概览
简要总结
Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18-80 with a diagnosis of occipital neuralgia or migraine overlying the occipital region.
- •A diagnosis of occipital neuralgia will be based on the International Classification of Headache Disorders (ICHD), whose criteria include: paroxysmal stabbing pain in the distribution of the GON, tenderness over the affected nerve, and relief of pain for at least 3 hours after bupivacaine local anesthetic block of the affected nerve.
- •Patients may also be included if they have a diagnosis of migraine based on the ICHD criteria with predominance of pain over the occipital region that responded to occipital nerve block.
- •Patients must have failed oral medications including NSAIDs, opioids, and anticonvulsants for the management of their pain.
- •Failed treatment will be <50% pain reduction with oral medication.
- •Patients must report headache frequency of at least 10 days per month.
排除标准
- •Patients will be excluded from the trial if they have an unstable medical or psychological condition,
- •are pregnant,
- •have an implanted cardiac pacemaker or defibrillator that could not be disabled,
- •have had a craniotomy or scar tissue overlying the site from a previous surgery,
- •have a history of cervical spine fusion,
- •have evidence of elevated ICP or intracranial tumor,
- •or have previous RFA treatment of the greater or lesser occipital nerve.
研究组 & 干预措施
Ultrasound Guided Approach
Experimental
Ultrasound-guided approach to occipital nerve radiofrequency ablation
干预措施: Ultrasound Guided Approach (Procedure)
结局指标
主要结局
Reduction pain scores reported using an 11-point numeric rating scale (NRS)
时间窗: 18 Months
Pain scores will be assessed 0-10 at the beginning of the study and at the end. We will compare mean pain scores pre-intervention and post-intervention, and we expect mean pain scores will decrease by 4 points on the NRS
次要结局
- Frequency of headache days(18 months)
- Frequency of moderate-severe headaches(18 months)
- Use of acute pain medications(18 Months)
研究者
Timothy Sowder, MD
Principal Investigator
University of Kansas Medical Center
研究点 (1)
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