An interventional study of Pulsed Radiofrequency of the Sphenopalatine Ganglion in Migraine Disorders, Facial Pain Disorder, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic Cephalalgias, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
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).
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 55 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with refractory chronic headache or facial pain who undergo pulsed radiofrequency (PRF) of the sphenopalatine ganglion under fluoroscopic guidance
Procedure: Pulsed Radiofrequency of the Sphenopalatine Ganglion
Fluoroscopy-guided infrazygomatic approach. A 22-gauge, 10-cm RF needle is placed in the pterygopalatine fossa. Pulsed radiofrequency (PRF) is applied at 45V, with 20-ms pulses and 480-ms silent phases. The procedure aims to achieve neuromodulation without thermal tissue damage (local temperature \< 42°C).
Also known as: Pterygopalatine Ganglion Radiofrequency
Assessment of Pain Intensity Reduction Using the Visual Analog Scale (VAS) Following Sphenopalatine Ganglion Pulsed Radiofrequency
"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."
Time frame: "Baseline, 1 week, 3 months, and 6 months post-procedure
Change in Pain Intensity via Visual Analog Scale (VAS)
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.
Time frame: Baseline, 1 week, 3 months, and 6 months post-procedure.
Plan to share: No — To ensure participant privacy and confidentiality, individual participant data will not be shared with outside researchers.
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Oct 2025, 6 months.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 6 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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