The Efficacy and Safety of Pulsed Radiofrequency Combined With Continuous Radiofrequency for the Trigeminal Neuralgia

Study Overview
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Brief Summary
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Trigeminal neuralgia is a very painful condition, and radiofrequency therapy is reserved for patients who are resistant or intolerant to pharmacological therapy. Continuous radiofrequency and pulsed radiofrequency both have advantages and disadvantages. Recently, studies have found that pulsed radiofrequency combined with low-temperature (<65 °C) continuous radiofrequency increases the efficacy of the treatment, without leading to a significant increase in complications caused by nerve lesions. However, these reports have some limitations. The investigators plan to conduct a randomized, controlled study to compare the efficacy of applying high-voltage pulsed radiofrequency, with and without low-temperature continuous radiofrequency, to the gasserian ganglion for the treatment of trigeminal neuralgia. The primary outcome will be the effectiveness of the treatment after 12 months which is the percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score between I-III.

Official Title
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The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Procedure: High-voltage pulsed radiofrequency
* Procedure: Low-temperature continuous radiofrequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd Edition criteria. Aged 18-75 years (inclusive), no sex limitation. Suffering from severe trigeminal neuralgia that cannot be alleviated effectively using conservative medical therapy such as carbamazepine, oxcarbazepine. Numeric rating scale score≥7 before the procedure. Agreed to sign the informed consent form. Exclusion Criteria: Secondary trigeminal neuralgia such as trigeminal neuralgia attributed to a space-occupying lesion or multiple sclerosis. Infection at the puncture site. A history of psychiatric disease. Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest X-ray. Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (II-III of the New York Heart Association classification). A history of abuse of narcotics. A history of receiving continuous radiofrequency to the gasserian ganglion or peripheral branches; glycerol rhizolysis; balloon compression; gamma knife; or any other neuroablative treatments. A history of receiving microvascular decompression.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed radiofrequency + Continuous radiofrequency<br> | Procedure: High-voltage pulsed radiofrequency<br>* 2 Hz of pulsed radiofrequency will be administered at a voltage of 70 V, temperature of 42 °C, pulse width of 20 ms, and treatment time of 600 s.<br>Procedure: Low-temperature continuous radiofrequency<br>* Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.<br>|
| Active Comparator: Pulsed radiofrequency<br> | Procedure: High-voltage pulsed radiofrequency<br>* 2 Hz of pulsed radiofrequency will be administered at a voltage of 70 V, temperature of 42 °C, pulse width of 20 ms, and treatment time of 600 s.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III | 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) will be used to evaluate the efficacy of the treatment. Twelve months after the procedure, participants with Barrow Neurological Institute scores of I-III will be defined as having received effective treatment. The primary outcome will be the effectiveness of the treatment after 12 months. | Twelve months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Barrow Neurological Institute Pain Intensity Score | 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) will be used to evaluate the efficacy of the treatment. | On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure | 
| Numeric rating scale | Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable). | On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure | 
| Dose of carbamazepine or oxcarbazepine | Dose of carbamazepine or oxcarbazepine per day (mg/day) | On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure | 
| Patient satisfaction scores on the 5-point Likert scale | 1: poor, 2: fair, 3: good, 4: very good, 5: excellent | After 1, 6 and 12 months following the procedure | 
| The World Health Organization Quality of Life (WHOQOL)-BREF | Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale. | After 1, 6 and 12 months following the procedure | 
| Numbness | The Barrow Neurological Institute facial numbness scores (I: No facial numbness; II: Mild facial numbness, not bothersome; III: Facial Numbness, somewhat bothersome; IV: Facial numbness, very bothersome) will be used to evaluate the facial numbness. | On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure | 
| Number of participants with anesthesia dolorosa | The participant's facial sensation decreased, accompanied by pain | Within 12 months of the procedure | 
| Number of participants with masticator weakness | Occlusal dysfunction or a lower degree of masseter muscle fullness on one side when biting hard. | Within 12 months of the procedure | 
| Number of participants with corneal anesthesia | When touching the sclera with a cotton swab hair does not cause the eyelids to close quickly. | Within 12 months of the procedure | 
| Number of participants with keratitis | Eye dryness and pain, photophobia, lacrimation, excess mucus and other conditions diagnosed as keratitis by an ophthalmologist | Within 12 months of the procedure | 
| Number of participants with adverse reactions | Nausea, vomiting, and facial hematoma during and after the procedure; headache, dizziness, and cerebrospinal fluid leakage occurring within two weeks of the procedure. | Within two weeks of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trigeminal neuralgia, Pulsed radiofrequency, Continuous radiofrequency, High-voltage pulsed radiofrequency combined with low-temperature continuous radiofrequency