Clinical Outcomes of Sphenopalatine Ganglion Pulsed Radiofrequency in Refractory Craniofacial Pain Syndromes: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Assessment of Pain Intensity Reduction Using the Visual Analog Scale (VAS) Following Sphenopalatine Ganglion Pulsed Radiofrequency
研究概览
简要总结
Purpose of the Study: This study aims to evaluate the clinical effectiveness and long-term outcomes of "Sphenopalatine Ganglion (SPG) Pulsed Radiofrequency (PRF)" treatment in patients with chronic headaches and facial pain. The SPG is a major neural junction for craniofacial pain signaling. PRF is a safe, minimally invasive technique that modulates pain transmission without causing thermal damage to the nerve tissue.
Methodology: The study will include 55 volunteer patients at the Ankara Bilkent City Hospital Algology Clinic who are unresponsive to medical treatments. Patients will undergo the standard "fluoroscopy-guided infrazygomatic approach." Pain intensity (VAS), quality of life, patient satisfaction, and changes in analgesic consumption will be recorded at baseline and during follow-up visits at 1 week, 1 month, 3 months, and 6 months post-procedure using various clinical parameters.
Expected Benefits and Risks: The research intends to provide evidence regarding the 6-month long-term impact of this intervention on pain scores and patient well-being. Since the study follows routine clinical practices, it poses no additional risks to participants and aims to optimize future treatment strategies.
详细描述
Study Design and Population This single-center, prospective study involves 55 patients diagnosed with chronic headaches and facial pain disorders, including Cluster Headache, Chronic Migraine, Trigeminal Neuralgia, and other Trigeminal Autonomic Cephalalgias (TACs). Participants are selected from patients who have been symptomatic for more than 3 months and are refractory to conventional medical treatments.
Interventional Procedure All procedures are performed in the operating room under fluoroscopic guidance, following the routine clinical practice of the Algology Department:
Positioning: Patients are placed in the supine position. A lateral fluoroscopic view of the face is obtained, ensuring the mandibular rami are superimposed.
Needle Placement: A 22-gauge, 10-cm curved radiofrequency (RF) needle with a 5-mm active tip is advanced via the infrazygomatic approach toward the pterigopalatine fossa.
Confirmation: Proper needle tip positioning is confirmed by intermittent anteroposterior (AP) imaging and sensory stimulation (50 Hz, <0.5 V), aimed at eliciting paresthesia in the maxillary nerve distribution.
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
盲法说明
No masking is involved in this open-label study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older (no upper age limit)
- •Patients diagnosed with refractory chronic headache (including cluster headache, migraine, paroxysmal hemicrania, hemicrania continua, SUNCT, or SUNA) or chronic orofacial pain / trigeminal neuralgia
- •Pain duration of at least 3 months
- •Pain intensity score (VAS or NRS) > 3 out of 10
- •Patients unresponsive to conservative medical treatments
- •Patients scheduled for sphenopalatine ganglion (SPG) pulsed radiofrequency (PRF) treatment as part of routine clinical care
- •Ability and willingness to provide written informed consent
排除标准
- •Systemic infection or local skin infection at the needle insertion site
- •Known coagulopathy or bleeding disorders
- •Presence of a cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
- •Presence of an intracranial mass or significant anatomical distortion in the pterygopalatine fossa region
- •Previous surgical intervention involving the sphenopalatine ganglion
- •Pregnancy or breastfeeding
- •Severe psychiatric or cognitive disorders preventing reliable pain assessment or follow-up
- •Hemodynamic instability
- •Refusal to participate in the study or undergo the procedure
研究组 & 干预措施
SPG Pulsed Radiofrequency Group
Patients with refractory chronic headache or facial pain who undergo pulsed radiofrequency (PRF) of the sphenopalatine ganglion under fluoroscopic guidance
干预措施: Pulsed Radiofrequency of the Sphenopalatine Ganglion (Procedure)
结局指标
主要结局
Assessment of Pain Intensity Reduction Using the Visual Analog Scale (VAS) Following Sphenopalatine Ganglion Pulsed Radiofrequency
时间窗: "Baseline, 1 week, 3 months, and 6 months post-procedure
"The Visual Analog Scale (VAS) is a validated measurement tool used to assess pain intensity. It consists of a 10-cm (100-mm) horizontal line anchored by two verbal descriptors: 'no pain' (score 0) and 'the worst imaginable pain' (score 10). Patients are asked to mark the point on the line that represents their current pain level. Lower scores indicate a reduction in pain intensity and an improvement in the patient's clinical status."
Change in Pain Intensity via Visual Analog Scale (VAS)
时间窗: Baseline, 1 week, 3 months, and 6 months post-procedure.
A scale ranging from 0 (no pain) to 10 (worst imaginable pain). The goal is to measure the reduction in pain scores compared to baseline.
次要结局
未报告次要终点