Trigeminal NeuralgiaNCT06620172
CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia
A study testing CT-guided Radiofrequency Thermocoagulation (RFT) and Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT) in people with Trigeminal Neuralgia and Trigeminal Neuralgia, Idiopathic, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effectiveness and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in treating idiopathic trigeminal neuralgia (TN) in adults aged 18 and older. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trigeminal Neuralgia, Trigeminal Neuralgia, Idiopathic
- What is being tested?
- CT-guided Radiofrequency Thermocoagulation (RFT) and Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2024to 10 Oct 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >18 years
- Idiopathic trigeminal neuralgia (TN) based on the International Headache Society criteria
- Pain for at least six months and a NRS score greater than 6 despite medical treatment
- Able to provide informed consent.
- Agree to follow the study procedures and attend follow-up visits.
Who cannot join
- Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
- Trigeminal autonomic cephalalgias accompanied by autonomic symptoms
- Dental or temporomandibular joint pathologies
- Previous interventional procedures or surgery for TN
- Coagulopathy or use of antiaggregants and anticoagulants
- Cardiac pacemaker
Show all 11Show fewer
- Renal-hepatic insufficiency
- Diagnosis of psychiatric illness
- Malignancy
- Injection site or systemic infection
- Current participation in another clinical trial that could interfere with the outcomes of this study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University, Faculty of Medicine
Zagazig, Sharqia Province, 44519
About this study
Official title: CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial
The goal of this clinical trial is to compare the effectiveness and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in treating idiopathic trigeminal neuralgia (TN) in adults aged 18 and older.
The main questions it aims to answer are:
Read more
- Does CT-guided TG-RFT provide better pain relief compared to fluoroscopy-guided TG-RFT?
- What are the differences in medication consumption between the two methods?
- What are the procedure-related adverse events for both methods?
Investigators will compare CT-guided TG-RFT to fluoroscopy-guided TG-RFT to see if one method is superior in treating idiopathic TN.
Participants will:
- Undergo either CT-guided or fluoroscopy-guided TG-RFT procedure
- Be monitored post-procedure and followed up at 1, 3, and 6 months for pain relief, medication consumption, and adverse events.
Read the detailed description
This randomized controlled trial aims to compare the efficacy and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in patients with idiopathic trigeminal neuralgia (TN). Idiopathic TN is characterized by severe, recurrent facial pain, and radiofrequency thermocoagulation is a common interventional treatment option.
Participants eligible for this study will be adults over 18 years old, diagnosed with idiopathic TN based on the International Headache Society criteria, experiencing pain for at least six months with a numeric rating scale (NRS) score greater than 6 despite medical treatment.
Exclusion criteria include vascular compression of the trigeminal nerve by MRI, secondary causes such as multiple sclerosis, trigeminal autonomic cephalalgias, dental or temporomandibular joint pathologies, previous interventional procedures or surgery for TN, coagulopathy, use of antiaggregants and anticoagulants, cardiac pacemaker, renal-hepatic insufficiency, psychiatric illness, malignancy, or infection at the injection site or systemic infection.
Participants will be randomly assigned to either the CT-guided or fluoroscopy-guided RFT group using a computer-generated randomization list. Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The CT-guided RFT will use real-time CT imaging for needle placement and monitoring, while the fluoroscopy-guided RFT will use fluoroscopic imaging.
The primary outcome measure is pain relief, assessed at 1-, 3-, and 6-months post-procedure using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS). Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events.
This study aims to provide valuable insights into the comparative effectiveness and safety of CT-guided versus fluoroscopy-guided TG-RFT in managing idiopathic TN, potentially guiding future clinical practice.
- Being tested
- CT-guided Radiofrequency Thermocoagulation (RFT), Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT)
- Keywords
- CT-guided Radiofrequency Thermocoagulation, Fluoroscopy-guided Radiofrequency Thermocoagulation, Idiopathic Trigeminal Neuralgia, Pain Management, Interventional Pain Treatment
- Medical subject headings
- Trigeminal Neuralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided Radiofrequency Thermocoagulation (RFT)Procedure or surgery
Participants in this group will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT). The procedure involves real-time CT imaging to guide the placement of the needle and monitor the process.
Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT)Procedure or surgery
Participants in this group will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT). The procedure utilizes fluoroscopic imaging for needle placement and monitoring.
| Study group | Role | What they receive |
|---|---|---|
| CT-guided RFT | Experimental | Participants will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with real-time CT imaging for needle placement and monitoring. Receives: Procedure: CT-guided Radiofrequency Thermocoagulation (RFT) |
| Fluoroscopy-guided RFT | Active comparator | Participants will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with fluoroscopic imaging for needle placement and monitoring. Receives: Procedure: Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief - Numeric Rating Scale (NRS)
The primary outcome measure will be the level of pain relief, as assessed by the Numeric Rating Scale (NRS), a 0-10 scale where 0 represents "no pain" and 10 represents "worst possible pain.". Pain levels will be recorded at baseline (pre-procedure), immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.
Measured: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
Pain Relief - Visual Analog Scale (VAS)
Additionally, pain relief will be assessed by the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." Pain levels will be recorded at the same time points: baseline, immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.
Measured: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
Secondary outcomes (2)
Medication Consumption
Changes in medication consumption will be assessed using the Medication Quantification Scale III (MQS III) at 6 months post-procedure. This measure will evaluate the impact of the interventions on the need for medications to manage trigeminal neuralgia.
Measured: 6 months post-procedure
Procedure-related Adverse Events
Adverse events related to the interventions will be systematically recorded to evaluate the safety profile of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT). Adverse events will be monitored and recorded immediately post-procedure and during follow-up visits at 1, 3, and 6 months.
Measured: Immediately post-procedure, 1 month, 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 posted1 Oct 2024
- Study start10 Nov 2024
- Primary completion10 May 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Awad Bessar, Zagazig University
- Investigators
- Ahmed A Bessar, MD, PhD, Principal investigator, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620172
- Sponsor's protocol ID
- TN_RFT
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06620172
- Acronym / sponsor ID
- TN_RFT
- Keywords
- CT-guided Radiofrequency Thermocoagulation, Fluoroscopy-guided Radiofrequency Thermocoagulation, Idiopathic Trigeminal Neuralgia, Pain Management, Interventional Pain Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 1 Oct 2024 (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.
The goal of this clinical trial is to compare the effectiveness and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in treating idiopathic trigeminal neuralgia (TN) in adults aged 18 and older.
The main questions it aims to answer are:
- Does CT-guided TG-RFT provide better pain relief compared to fluoroscopy-guided TG-RFT?
- What are the differences in medication consumption between the two methods?
- What are the procedure-related adverse events for both methods?
Investigators will compare CT-guided TG-RFT to fluoroscopy-guided TG-RFT to see if one method is superior in treating idiopathic TN.
Participants will:
- Undergo either CT-guided or fluoroscopy-guided TG-RFT procedure
- Be monitored post-procedure and followed up at 1, 3, and 6 months for pain relief, medication consumption, and adverse events.
Detailed description
This randomized controlled trial aims to compare the efficacy and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in patients with idiopathic trigeminal neuralgia (TN). Idiopathic TN is characterized by severe, recurrent facial pain, and radiofrequency thermocoagulation is a common interventional treatment option.
Participants eligible for this study will be adults over 18 years old, diagnosed with idiopathic TN based on the International Headache Society criteria, experiencing pain for at least six months with a numeric rating scale (NRS) score greater than 6 despite medical treatment.
Exclusion criteria include vascular compression of the trigeminal nerve by MRI, secondary causes such as multiple sclerosis, trigeminal autonomic cephalalgias, dental or temporomandibular joint pathologies, previous interventional procedures or surgery for TN, coagulopathy, use of antiaggregants and anticoagulants, cardiac pacemaker, renal-hepatic insufficiency, psychiatric illness, malignancy, or infection at the injection site or systemic infection.
Participants will be randomly assigned to either the CT-guided or fluoroscopy-guided RFT group using a computer-generated randomization list. Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The CT-guided RFT will use real-time CT imaging for needle placement and monitoring, while the fluoroscopy-guided RFT will use fluoroscopic imaging.
The primary outcome measure is pain relief, assessed at 1-, 3-, and 6-months post-procedure using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS). Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events.
This study aims to provide valuable insights into the comparative effectiveness and safety of CT-guided versus fluoroscopy-guided TG-RFT in managing idiopathic TN, potentially guiding future clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-guided RFT | Experimental | Procedure: CT-guided Radiofrequency Thermocoagulation (RFT)Participants will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with real-time CT imaging for needle placement and monitoring. |
| Fluoroscopy-guided RFT | Active comparator | Procedure: Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT)Participants will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with fluoroscopic imaging for needle placement and monitoring. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age >18 years
- Idiopathic trigeminal neuralgia (TN) based on the International Headache Society criteria
- Pain for at least six months and a NRS score greater than 6 despite medical treatment
- Able to provide informed consent.
- Agree to follow the study procedures and attend follow-up visits.
Key exclusion criteria (11 listed)
- Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
- Trigeminal autonomic cephalalgias accompanied by autonomic symptoms
- Dental or temporomandibular joint pathologies
- Previous interventional procedures or surgery for TN
- Coagulopathy or use of antiaggregants and anticoagulants
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 |
|---|---|---|
| CT-guided Radiofrequency Thermocoagulation (RFT)Participants in this group will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT). The procedure involves real-time CT imaging to guide the placement of the needle and monitor the process. | Procedure or surgery | CT-guided RFT |
| Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT)Participants in this group will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT). The procedure utilizes fluoroscopic imaging for needle placement and monitoring. | Procedure or surgery | Fluoroscopy-guided RFT |
Primary outcome
Pain Relief - Numeric Rating Scale (NRS)
Time frame: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
The primary outcome measure will be the level of pain relief, as assessed by the Numeric Rating Scale (NRS), a 0-10 scale where 0 represents "no pain" and 10 represents "worst possible pain.". Pain levels will be recorded at baseline (pre-procedure), immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.
Pain Relief - Visual Analog Scale (VAS)
Time frame: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
Additionally, pain relief will be assessed by the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." Pain levels will be recorded at the same time points: baseline, immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.
2 secondary outcomes
Medication Consumption
Time frame: 6 months post-procedure
Procedure-related Adverse Events
Time frame: Immediately post-procedure, 1 month, 3 months, and 6 months post-procedure
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 22 Sep 2026.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
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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.
Ahmed A Bessar, MD, PhD principal investigator
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided Radiofrequency Thermocoagulation (RFT) and Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT) in people with Trigeminal Neuralgia and Trigeminal Neuralgia, Idiopathic, run by Zagazig University at 1 site in Egypt.
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 5 inclusion and 11 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 22 Sep 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 Egypt. 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?
Pain Relief - Numeric Rating Scale (NRS) (time frame: Baseline, immediately post-procedure, 1 month, 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 22 Sep 2026.