Sphenopalatine Ganglion Pulsed Radiofrequency Treatment Outcomes (SPG-PRF)

March 16, 2026 updated by: Ankara City Hospital Bilkent

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPG Pulsed Radiofrequency Group
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).
Other Names:
  • Pterygopalatine Ganglion Radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Pain Intensity Reduction Using the Visual Analog Scale (VAS) Following Sphenopalatine Ganglion Pulsed Radiofrequency
Time Frame: "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."
"Baseline, 1 week, 3 months, and 6 months post-procedure
Change in Pain Intensity via Visual Analog Scale (VAS)
Time Frame: 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.
Baseline, 1 week, 3 months, and 6 months post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Nevcihan ŞAHUTOĞLU BAL, MD, Ankara Bilkent City Hospital, Department of Algology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPG-PRF-2025
  • E2-25-10589 (Other Identifier: Ankara Bilkent City Hospital Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To ensure participant privacy and confidentiality, individual participant data will not be shared with outside researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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