Clinical Outcomes of Sphenopalatine Ganglion Pulsed Radiofrequency in Refractory Craniofacial Pain Syndromes: A Prospective Clinical Study
Clinical Outcomes of Sphenopalatine Ganglion Pulsed Radiofrequency in Refractory Craniofacial Pain Syndromes: A Prospective Clinical Study
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.
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.
Application: Once the position is verified and intravascular entry is ruled out, Pulsed Radiofrequency (PRF) is applied at 45 V with 20-ms bursts and 480-ms silent phases, maintaining a local temperature below 42°C to prevent thermal tissue damage.
Outcome Measures and Follow-up The study evaluates the efficacy and safety of the procedure over a 6-month period. Data collection is performed at baseline (pre-procedure) and post-procedure at 1 week, 1 month, 3 months, and 6 months.
The primary and secondary parameters include:
Pain Intensity: Measured using the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS).
Clinical Efficacy: Assessed via the Global Perceived Effect (GPE) scale (7-point scale ranging from "very much improved" to "very much worse").
Patient Satisfaction: Measured using a 7-point Likert Scale.
Medication Consumption: Changes in analgesic and prophylactic drug use (3-point Likert scale: stopped,increased, stable, or decreased).
Safety Profile: Monitoring for any procedure-related side effects or complications during and after the PRF application.
Statistical Analysis Data will be analyzed using SPSS 25.0. Quantitative data will be tested for normality using Kolmogorov-Smirnov/Shapiro-Wilk tests. Repeated Measures ANOVA or Friedman tests will be utilized to compare longitudinal data across the five time points (baseline to 6 months).
Inclusion Criteria:
Exclusion Criteria: