Trigeminal NeuralgiaNCT06366139
Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia
A study testing Radiofrequency thermocoagulation of the trigeminal ganglion and Maxillary/Mandibular nerve pulsed radiofrequency in people with Trigeminal Neuralgia and Headache Disorders, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Trigeminal Neuralgia, Headache Disorders
- What is being tested?
- Radiofrequency thermocoagulation of the trigeminal ganglion and Maxillary/Mandibular nerve pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2023to 7 Mar 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic TN according to the international headache society
- Pain for at least 6 months and numeric rating scale (NRS) score greater than 6 despite medical treatment (despite the maximum tolerated dose of carbamazepine, gabapentinoid or tramadol)
Who cannot join
- Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
- Dental or temporomandibular joint pathologies
- Previous interventional procedures or surgery for TN
- Coagulopathy or use of antiaggregants and anticoagulants
- Cardiac pacemaker
- Renal-hepatic insufficiency
Show all 9Show fewer
- Diagnosis of psychiatric illness
- Malignancy and
- Injection site or systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Trigeminal Ganglion Radiofrequency Thermocoagulation and Ultrasound-guided Maxillary-mandibular Pulsed Radiofrequency in the Treatment of Trigeminal Neuralgia
Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.
Read the detailed description
Trigeminal neuralgia (TN) is a very severe, unilateral, short, lightning-like pain that starts and ends suddenly and is limited to the areas related to the branches of the trigeminal nerve. The pain can be triggered by stimuli such as washing face, shaving, smoking, talking and/or brushing teeth (trigger factors) and usually occurs spontaneously.
Treatment of TN is complex despite the use of multiple medications and may be resistant. Interventional procedures are an option in cases that do not respond to medical treatments or if there are side effects. Interventional procedures include trigeminal ganglion RFT and maxillary-mandibular (max/mand) nerve PRF. PRF delivers short bursts of high-voltage electrical current to the target nerve, creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a continuous current that heats the target tissue, causing coagulation necrosis on nerves.
Although trigeminal ganglion RFT is a frequently performed method in the treatment of idiopathic TN, there is limited literature data on ultrasonography (US)-guided max/mand nerve PRF.
The primary aim of this study was to compare the efficacy of trigeminal ganglion RFT and max/mand nerve PRF for TN. Secondary aims were to determine the effects of interventions on drug consumption and interventional safety based on adverse events. A total of at least 44 patients, 22 patients in each group, will be enrolled for comparison. NRS, and MQS III scores before treatments, 1 month, and 6 months after treatments will be compared both within and between groups.
- Conditions
- Trigeminal Neuralgia, Headache Disorders
- Being tested
- Radiofrequency thermocoagulation of the trigeminal ganglion, Maxillary/Mandibular nerve pulsed radiofrequency
- Keywords
- Pulsed Radiofrequency Treatment, Radiofrequency Ablation, Maxillary Nerve, Mandibular Nerve
- Medical subject headings
- Trigeminal Neuralgia, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency thermocoagulation of the trigeminal ganglionProcedure or surgery
The patient is placed in the supine position and the foramen ovale is identified medial to the coronoid process of the mandible by giving the head a submental oblique position under fluoroscopic guidance. A 20-gauge, 5 mm active type, and 100 mm radiofrequency cannula is inserted 2 cm lateral to the commissura labialis and advanced towards the foramen. After entering the foramen ovale with a lateral fluoroscopic image, the radiofrequency cannula is connected to the radiofrequency generator and sensory and motor stimulations are performed to confirm the target maxillary and mandibular nerves. The radiofrequency lesion is applied at 60°C, 65°C and 70°C for 60-seconds periods. The patient is observed for side effects for 1 hour after the procedure.
Maxillary/Mandibular nerve pulsed radiofrequencyProcedure or surgery
The patient is placed in the lateral decubitus position with the affected side up. A 5-12 MHz linear ultrasound probe is placed in the infrazygomatic area above the maxilla at a 45° inclination in both the frontal and horizontal planes. The probe position allows visualization of the pterygopalatine fossa, which is limited to the maxilla anteriorly and the greater wing of the sphenoid posteriorly. Real-time ultrasound guidance allows direct localization of the internal maxillary artery and identification of the needle tip. The radiofrequency cannula was connected to the radiofrequency generator and PRF was applied at 42°C for 240 seconds after confirming the localization of the maxillary and mandibular nerve by obtaining appropriate responses to sensory and motor stimulation.
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency thermocoagulation group | Active comparator | Trigeminal ganglion radiofrequency thermocoagulation for trigeminal neuralgia Receives: Procedure: Radiofrequency thermocoagulation of the trigeminal ganglion |
| pulsed radiofrequency group | Active comparator | Maxillary mandibular nerve pulsed radiofrequency for trigeminal neuralgia Receives: Procedure: Maxillary/Mandibular nerve pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Measured: Change from baseline to 1st and 6th month after treatment
Secondary outcomes (1)
The Medication Quantification Scale III (MQS III)
The MQS III is a validated tool in medical research that quantifies medication regimens by assigning a numerical value to each medication based on its class, dosage, and associated risks. This scale aids clinicians and researchers in tracking changes in pain levels throughout a treatment course or study, providing an objective measure of medication consumption and its potential negative impact.
Measured: Change from baseline 6th month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start11 Jan 2023
- Primary completion4 Feb 2024
- Study completion7 Mar 2024
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.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher Rabia Genc Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366139
- Sponsor's protocol ID
- Trigeminal RFT vs max/mand PRF
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Trigeminal Ganglion Radiofrequency Thermocoagulation and Ultrasound-guided Maxillary-mandibular Pulsed Radiofrequency in the Treatment of Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT06366139
- Acronym / sponsor ID
- Trigeminal RFT vs max/mand PRF
- Conditions
- Trigeminal Neuralgia, Headache Disorders
- Keywords
- Pulsed Radiofrequency Treatment, Radiofrequency Ablation, Maxillary Nerve, Mandibular Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 15 Apr 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.
Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.
Detailed description
Trigeminal neuralgia (TN) is a very severe, unilateral, short, lightning-like pain that starts and ends suddenly and is limited to the areas related to the branches of the trigeminal nerve. The pain can be triggered by stimuli such as washing face, shaving, smoking, talking and/or brushing teeth (trigger factors) and usually occurs spontaneously.
Treatment of TN is complex despite the use of multiple medications and may be resistant. Interventional procedures are an option in cases that do not respond to medical treatments or if there are side effects. Interventional procedures include trigeminal ganglion RFT and maxillary-mandibular (max/mand) nerve PRF. PRF delivers short bursts of high-voltage electrical current to the target nerve, creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a continuous current that heats the target tissue, causing coagulation necrosis on nerves.
Although trigeminal ganglion RFT is a frequently performed method in the treatment of idiopathic TN, there is limited literature data on ultrasonography (US)-guided max/mand nerve PRF.
The primary aim of this study was to compare the efficacy of trigeminal ganglion RFT and max/mand nerve PRF for TN. Secondary aims were to determine the effects of interventions on drug consumption and interventional safety based on adverse events. A total of at least 44 patients, 22 patients in each group, will be enrolled for comparison. NRS, and MQS III scores before treatments, 1 month, and 6 months after treatments will be compared both within and between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency thermocoagulation group | Active comparator | Procedure: Radiofrequency thermocoagulation of the trigeminal ganglionTrigeminal ganglion radiofrequency thermocoagulation for trigeminal neuralgia |
| pulsed radiofrequency group | Active comparator | Procedure: Maxillary/Mandibular nerve pulsed radiofrequencyMaxillary mandibular nerve pulsed radiofrequency for trigeminal neuralgia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with idiopathic TN according to the international headache society
- Pain for at least 6 months and numeric rating scale (NRS) score greater than 6 despite medical treatment (despite the maximum tolerated dose of carbamazepine, gabapentinoid or tramadol)
Key exclusion criteria (9 listed)
- Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
- Dental or temporomandibular joint pathologies
- Previous interventional procedures or surgery for TN
- Coagulopathy or use of antiaggregants and anticoagulants
- Cardiac pacemaker
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 |
|---|---|---|
| Radiofrequency thermocoagulation of the trigeminal ganglionThe patient is placed in the supine position and the foramen ovale is identified medial to the coronoid process of the mandible by giving the head a submental oblique position under fluoroscopic guidance. A 20-gauge, 5 mm active type, and 100 mm radiofrequency cannula is inserted 2 cm lateral to the commissura labialis and advanced towards the foramen. After entering the foramen ovale with a lateral fluoroscopic image, the radiofrequency cannula is connected to the radiofrequency generator and sensory and motor stimulations are performed to confirm the target maxillary and mandibular nerves. The radiofrequency lesion is applied at 60°C, 65°C and 70°C for 60-seconds periods. The patient is observed for side effects for 1 hour after the procedure. | Procedure or surgery | radiofrequency thermocoagulation group |
| Maxillary/Mandibular nerve pulsed radiofrequencyThe patient is placed in the lateral decubitus position with the affected side up. A 5-12 MHz linear ultrasound probe is placed in the infrazygomatic area above the maxilla at a 45° inclination in both the frontal and horizontal planes. The probe position allows visualization of the pterygopalatine fossa, which is limited to the maxilla anteriorly and the greater wing of the sphenoid posteriorly. Real-time ultrasound guidance allows direct localization of the internal maxillary artery and identification of the needle tip. The radiofrequency cannula was connected to the radiofrequency generator and PRF was applied at 42°C for 240 seconds after confirming the localization of the maxillary and mandibular nerve by obtaining appropriate responses to sensory and motor stimulation. | Procedure or surgery | pulsed radiofrequency group |
Primary outcome
Numerical rating scale (NRS)
Time frame: Change from baseline to 1st and 6th month after treatment
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
1 secondary outcome
The Medication Quantification Scale III (MQS III)
Time frame: Change from baseline 6th month after treatment
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 15 Apr 2024.
Related trials for Trigeminal Neuralgia
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
RecruitingEarly Phase 1
Trigeminal Evoked Responses to Improve Rhizotomy
Trigeminal Neuralgia, Rhizotomy
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 1/2
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
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.
Gevher Rabia Genc Perdecioğlu study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency thermocoagulation of the trigeminal ganglion and Maxillary/Mandibular nerve pulsed radiofrequency in people with Trigeminal Neuralgia and Headache Disorders, run by Diskapi Teaching and Research Hospital 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 2 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 15 Apr 2024. 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?
Numerical rating scale (NRS) (time frame: Change from baseline to 1st and 6th month after treatment). 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 15 Apr 2024.