Trigeminal NeuralgiaNCT06240494
Predictive Factors in Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Trigeminal neuralgia is one of the most common craniofacial neuralgias and one of the most severe types of facial pain, typically limited to the distribution of the trigeminal nerve. The first-line treatment for trigeminal neuralgia is medical therapy and primarily antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Maxillary nerve and mandibular nerve pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 2 Dec 2023
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients who underwent maxillary and/or mandibular nerve pulsed radiofrequency for trigeminal neuralgia
Who may be able to join
- Diagnosis of trigeminal neuralgia according to the IHS 3-beta criteria
- No response to conservative treatment for > 3 months
- Magnetic resonance imaging within 1 year prior to injection
- Access to clinical data
Who cannot join
- Inadequate medical records with missing numerical rating scale (NRS) scores and MRI images
- Patients lost to follow-up within three months after the procedure
- History of surgery or gamma-knife radiosurgery for trigeminal neuralgia
- History of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors Associated With Successful Response to Ultrasound-guided Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
Trigeminal neuralgia is one of the most common craniofacial neuralgias and one of the most severe types of facial pain, typically limited to the distribution of the trigeminal nerve. The first-line treatment for trigeminal neuralgia is medical therapy and primarily antiepileptic drugs. Various interventional and surgical methods can be used in patients who do not respond to medical treatment or who cannot tolerate side effects. Pulsed radiofrequency treatment of maxillary and mandibular nerves may provide longer-lasting pain relief in trigeminal neuralgia.This study aimed to investigate the clinical and demographic characteristics affecting treatment success in patients who underwent ultrasound-guided pulsed radiofrequency of the maxillary and/or mandibular nerves for trigeminal neuralgia.
Read the detailed description
Pulsed radiofrequency treatment applied to the maxillary and mandibular nerves, which are the peripheral branches of the trigeminal nerve, is frequently used in patients with trigeminal neuralgia who do not adequately respond to medical treatment.
Pain intensity was evaluated at baseline and 3 months after US-guided maxillary and/or mandibular nerve PRF treatment using NRS (numerical rating scale). The primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 3 months was defined as a positive categorical outcome.
In addition, demographic data such as age (years), gender, duration of pain (months), etiology (idiopathic or secondary), MRI findings (normal findings or abnormal findings due to conditions such as vascular compression and demyelinating plaque), pain side (unilateral or bilateral), and history of Gasser ganglion RF ablation were obtained from patient data. NRS scores before and 3 months after PRF were collected from the patient data and recorded. Pre-procedural cranial MRI and MR cisternography reports were accessed from patient records, and any abnormalities were recorded. We retrospectively analyzed the patient's electronic medical history records and the archive system containing the imaging results to obtain the variables.
The main aim of this study was to determine the clinical and demographic variables associated with treatment outcomes in patients with TN who underwent PRF of the maxillary and mandibular nerves. The secondary aim of this study was to determine the incidence of procedure-related adverse events.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Maxillary nerve and mandibular nerve pulsed radiofrequency
- Keywords
- mandibular nerve, maxillary nerve, pulsed radiofrequency, ultrasound, analgesia
- 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.
Maxillary nerve and mandibular nerve pulsed radiofrequencyProcedure or surgery
For maxillary nerve pulsed radiofrequency, the lineer transducer is placed distal and parallel to the zygomatic arch, bridging the coronoid and condylar processes and a 22 gauge 6 mm RF cannula was inserted into the target area. With sensory stimulation, patients experienced a distinct sensation in upper jaw, teeth, and palate. Then, PRF treatment was performed at 42 °C for 240 seconds.
For mandibular nerve pulsed radiofrequency, the transducer was placed distally and parallel to the zygomatic arch, bridging the coronoid and condylar processes. The pterygopalatine fossa was visualized and the needle was inserted to target area. With sensory stimulation, patients experienced a distinct sensation in the lower jaw and teeth. With motor stimulation, a throwing movement of the jaw was observed with contraction of the masseter and temporal muscles. PRF treatment was performed at 42 °C for 240 s.
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.
Measured: Change from Baseline NRS at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Sep 2022
- Primary completion1 Dec 2023
- Study completion2 Dec 2023
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 58 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
- Ömer Taylan Akkaya, MD, Principal investigator, Diskapi Teaching and Research HospitalEzgi Can, MD, Study director, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240494
- Sponsor's protocol ID
- Maxillary and mandibular RF
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors Associated With Successful Response to Ultrasound-guided Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT06240494
- Acronym / sponsor ID
- Maxillary and mandibular RF
- Conditions
- Trigeminal Neuralgia
- Keywords
- mandibular nerve, maxillary nerve, pulsed radiofrequency, ultrasound, analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 5 Feb 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 neuralgia is one of the most common craniofacial neuralgias and one of the most severe types of facial pain, typically limited to the distribution of the trigeminal nerve. The first-line treatment for trigeminal neuralgia is medical therapy and primarily antiepileptic drugs. Various interventional and surgical methods can be used in patients who do not respond to medical treatment or who cannot tolerate side effects. Pulsed radiofrequency treatment of maxillary and mandibular nerves may provide longer-lasting pain relief in trigeminal neuralgia.This study aimed to investigate the clinical and demographic characteristics affecting treatment success in patients who underwent ultrasound-guided pulsed radiofrequency of the maxillary and/or mandibular nerves for trigeminal neuralgia.
Detailed description
Pulsed radiofrequency treatment applied to the maxillary and mandibular nerves, which are the peripheral branches of the trigeminal nerve, is frequently used in patients with trigeminal neuralgia who do not adequately respond to medical treatment.
Pain intensity was evaluated at baseline and 3 months after US-guided maxillary and/or mandibular nerve PRF treatment using NRS (numerical rating scale). The primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 3 months was defined as a positive categorical outcome.
In addition, demographic data such as age (years), gender, duration of pain (months), etiology (idiopathic or secondary), MRI findings (normal findings or abnormal findings due to conditions such as vascular compression and demyelinating plaque), pain side (unilateral or bilateral), and history of Gasser ganglion RF ablation were obtained from patient data. NRS scores before and 3 months after PRF were collected from the patient data and recorded. Pre-procedural cranial MRI and MR cisternography reports were accessed from patient records, and any abnormalities were recorded. We retrospectively analyzed the patient's electronic medical history records and the archive system containing the imaging results to obtain the variables.
The main aim of this study was to determine the clinical and demographic variables associated with treatment outcomes in patients with TN who underwent PRF of the maxillary and mandibular nerves. The secondary aim of this study was to determine the incidence of procedure-related adverse events.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients who underwent maxillary and/or mandibular nerve pulsed radiofrequency for trigeminal neuralgia
Key inclusion criteria (4 listed)
- Diagnosis of trigeminal neuralgia according to the IHS 3-beta criteria
- No response to conservative treatment for > 3 months
- Magnetic resonance imaging within 1 year prior to injection
- Access to clinical data
Key exclusion criteria (4 listed)
- Inadequate medical records with missing numerical rating scale (NRS) scores and MRI images
- Patients lost to follow-up within three months after the procedure
- History of surgery or gamma-knife radiosurgery for trigeminal neuralgia
- History of malignancy
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 |
|---|---|---|
| Maxillary nerve and mandibular nerve pulsed radiofrequencyFor maxillary nerve pulsed radiofrequency, the lineer transducer is placed distal and parallel to the zygomatic arch, bridging the coronoid and condylar processes and a 22 gauge 6 mm RF cannula was inserted into the target area. With sensory stimulation, patients experienced a distinct sensation in upper jaw, teeth, and palate. Then, PRF treatment was performed at 42 °C for 240 seconds. For mandibular nerve pulsed radiofrequency, the transducer was placed distally and parallel to the zygomatic arch, bridging the coronoid and condylar processes. The pterygopalatine fossa was visualized and the needle was inserted to target area. With sensory stimulation, patients experienced a distinct sensation in the lower jaw and teeth. With motor stimulation, a throwing movement of the jaw was observed with contraction of the masseter and temporal muscles. PRF treatment was performed at 42 °C for 240 s. | Procedure or surgery | – |
Primary outcome
VAS
Time frame: Change from Baseline NRS at 3 months
Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.
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 29 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ömer Taylan Akkaya, MD principal investigator
Diskapi Teaching and Research Hospital
Ezgi Can, MD study director
Diskapi Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, 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 4 inclusion and 4 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 29 Mar 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?
VAS (time frame: Change from Baseline NRS at 3 months). 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 29 Mar 2024.