Migraine Disorders, Facial Pain Disorder, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic CephalalgiasSPG-PRFNCT07370142
Sphenopalatine Ganglion Pulsed Radiofrequency Treatment Outcomes
A study testing Pulsed Radiofrequency of the Sphenopalatine Ganglion in people with Migraine Disorders, Facial Pain Disorder, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic Cephalalgias, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders, Facial Pain Disorder, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic Cephalalgias
- What is being tested?
- Pulsed Radiofrequency of the Sphenopalatine Ganglion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Severe psychiatric or cognitive disorders preventing reliable pain assessment or follow-up
- Hemodynamic instability
- Refusal to participate in the study or undergo the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
Official title: 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.
Read the 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).
- Being tested
- Pulsed Radiofrequency of the Sphenopalatine Ganglion
- Keywords
- Pulsed Radiofrequency, Sphenopalatine Ganglion, Facial Pain, Chronic Headache
- Medical subject headings
- Migraine Disorders, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic Cephalalgias, Facial Pain, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Radiofrequency of the Sphenopalatine GanglionProcedure or surgery
Also called Pterygopalatine Ganglion Radiofrequency
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).
| Study group | Role | What they receive |
|---|---|---|
| SPG Pulsed Radiofrequency Group | Experimental | Patients with refractory chronic headache or facial pain who undergo pulsed radiofrequency (PRF) of the sphenopalatine ganglion under fluoroscopic guidance Receives: Procedure: Pulsed Radiofrequency of the Sphenopalatine Ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: "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.
Measured: Baseline, 1 week, 3 months, and 6 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start20 Mar 2025
- Primary completion1 Oct 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Disorders, Facial Pain Disorder, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic CephalalgiasStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-arm interventional study. All participants who meet the inclusion criteria will receive the same intervention (pulsed radiofrequency of the sphenopalatine ganglion). Patients will serve as their own controls, with baseline (pre-procedure) pain scores compared to post-procedure follow-up scores at multiple time points (1 week, 1 month, 3 months, and 6 months)."
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nevcihan ŞAHUTOĞLU BAL, MD, Principal investigator, Ankara Bilkent City Hospital, Department of Algology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370142
- Sponsor's protocol ID
- SPG-PRF-2025
- Other IDs
- E2-25-10589
- Acronym
- SPG-PRF
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure participant privacy and confidentiality, individual participant data will not be shared with outside researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Sphenopalatine Ganglion Pulsed Radiofrequency in Refractory Craniofacial Pain Syndromes: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07370142
- Acronym / sponsor ID
- SPG-PRF / SPG-PRF-2025
- Keywords
- Pulsed Radiofrequency, Sphenopalatine Ganglion, Facial Pain, Chronic Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-arm interventional study. All participants who meet the inclusion criteria will receive the same intervention (pulsed radiofrequency of the sphenopalatine ganglion). Patients will serve as their own controls, with baseline (pre-procedure) pain scores compared to post-procedure follow-up scores at multiple time points (1 week, 1 month, 3 months, and 6 months)."
| Arm | Type | Receives |
|---|---|---|
| SPG Pulsed Radiofrequency Group | Experimental | Procedure: Pulsed Radiofrequency of the Sphenopalatine GanglionPatients with refractory chronic headache or facial pain who undergo pulsed radiofrequency (PRF) of the sphenopalatine ganglion under fluoroscopic guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Radiofrequency of the Sphenopalatine GanglionAlso: Pterygopalatine Ganglion RadiofrequencyFluoroscopy-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). | Procedure or surgery | SPG Pulsed Radiofrequency Group |
Primary outcome
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."
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. To ensure participant privacy and confidentiality, individual participant data will not be shared with outside researchers.
Related trials for Migraine Disorders, Facial Pain Disorder, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic Cephalalgias
RecruitingPhase 2
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
Craniofacial Pain, Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevcihan ŞAHUTOĞLU BAL, MD principal investigator
Ankara Bilkent City Hospital, Department of Algology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency of the Sphenopalatine Ganglion in people with Migraine Disorders, Facial Pain Disorder, Cluster Headache, Trigeminal Neuralgia, Trigeminal Autonomic Cephalalgias, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.