Trigeminal NeuralgiaNCT05516888
Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.
A study testing radiofrequency of gasserian ganglion and radiofrequency of the peripheral trigeminal branches in people with Trigeminal Neuralgia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- radiofrequency of gasserian ganglion and radiofrequency of the peripheral trigeminal branches
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2022to 25 Aug 2023
- 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
- Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
- Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
- Agree to participate in the study
Who cannot join
- Infection at the puncture site.
- Coagulation disorder.
- Abnormal blood test (hepatic or renal function)
- History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
About this study
Official title: A Prospective, Randomized Comparison of the Radiofrequency of Gasserian Ganglion Versus Peripheral Branches of the Trigeminal Nerve for the Treatment of Trigeminal Neuralgia.
The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.
Read the detailed description
Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.
- Conditions
- Trigeminal Neuralgia
- Being tested
- radiofrequency of gasserian ganglion, radiofrequency of the peripheral trigeminal branches
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency of gasserian ganglionProcedure or surgery
radiofrequency ablation of the gasserian ganglion
radiofrequency of the peripheral trigeminal branchesProcedure or surgery
radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency of peripheral branches of the trigeminal nerve | Experimental | pulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve Receives: Procedure: radiofrequency of the peripheral trigeminal branches |
| Radiofrequency of gasserian ganglion | Active comparator | radiofrequency ablation of the gasserian ganglion Receives: Procedure: radiofrequency of gasserian ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Barrow Neurological Institute Pain Intensity Score
The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief).
Measured: six months
Secondary outcomes (2)
Numeric rating scale
Pain will evaluated by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Measured: baseline to six months
Patient satisfaction
Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start25 Aug 2022
- Primary completion1 Aug 2023
- Study completion25 Aug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Guven Kose, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516888
- Sponsor's protocol ID
- 138/14
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of the Radiofrequency of Gasserian Ganglion Versus Peripheral Branches of the Trigeminal Nerve for the Treatment of Trigeminal Neuralgia.
- ClinicalTrials.gov ID
- NCT05516888
- Acronym / sponsor ID
- 138/14
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 26 Aug 2022 (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 aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.
Detailed description
Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency of peripheral branches of the trigeminal nerve | Experimental | Procedure: radiofrequency of the peripheral trigeminal branchespulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve |
| Radiofrequency of gasserian ganglion | Active comparator | Procedure: radiofrequency of gasserian ganglionradiofrequency ablation of the gasserian ganglion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
- Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
- Agree to participate in the study
Key exclusion criteria (4 listed)
- Infection at the puncture site.
- Coagulation disorder.
- Abnormal blood test (hepatic or renal function)
- History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)
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 of gasserian ganglionradiofrequency ablation of the gasserian ganglion | Procedure or surgery | Radiofrequency of gasserian ganglion |
| radiofrequency of the peripheral trigeminal branchesradiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital) | Procedure or surgery | Radiofrequency of peripheral branches of the trigeminal nerve |
Primary outcome
The modified Barrow Neurological Institute Pain Intensity Score
Time frame: six months
The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief).
2 secondary outcomes
Numeric rating scale
Time frame: baseline to six months
Patient satisfaction
Time frame: six months
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 6 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of gasserian ganglion and radiofrequency of the peripheral trigeminal branches in people with 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 3 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 6 Sep 2023. 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?
The modified Barrow Neurological Institute Pain Intensity Score (time frame: six 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 6 Sep 2023.