High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

Study Overview
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Brief Summary
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The study is designed to compare the effectiveness and safety of high-voltage Pulsed radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients with ineffective conservative treatment and explore better non-surgical treatment methods for Trigeminal Neuralgia patients.

Detailed Description
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Trigeminal neuralgia (TN) is a paroxysmal, lightning-like, severe pain in the facial area innervated by trigeminal nerve. Patients who have failed to achieve benefits from drug treatment could try to undergo nerve block, a traditional conservative treatment. Pulsed radiofrequency (PRF) is a noninvasive pain intervention technique for the treatment of TN. However, its treatment effectiveness has rarely been reported and remains controversial among scholars. A recent single-center preliminary clinical study showed that high-voltage PRF had significant effectiveness in the treatment of TN. However, whether high-voltage PRF treatment can become an optional treatment for TN patients who have failed to achieve benefits from drug treatment still needs to be confirmed with standardized clinical studies by utilizing conservative nerve block treatment as a control. The study is designed to compare the effectiveness and safety of high-voltage PRF and nerve block for the treatment of primary TN patients with ineffective conservative treatment and explore better non-surgical treatment methods for TN patients.

Official Title
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Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

Conditions
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Idiopathic Trigeminal Neuralgia

Intervention / Treatment
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* Device: High-voltage pulsed radiofrequency
* Drug: Nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders. 18-75 years old. Response to drug treatment poorly or unable to tolerate the side effects of drugs. A BNI pain intensity scale score of IV-V. Supposed to undergo neurosurgical intervention according to Trigeminal Neuralgia treatment guidelines. Agree to participate in this trial and have signed the informed consent. Exclusion Criteria: Abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders. Abnormal electrocardiogram or chest X-ray results. Severe cardiopulmonary dysfunction. Infection at the puncture site. History of mental illness, or history of narcotic drug abuse. Allergy to local anesthetic drugs or steroids. Cannot cooperate with the treatment. History of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF Group<br>This group will undergo 42°C high-voltage pulsed radiofrequency treatment. | Device: High-voltage pulsed radiofrequency<br>* The manual PRF mode of the pain treatment generator will be turned on, the upper temperature limit will be set at 42°C, the PRF output voltage will be gradually increased to the highest voltage the patient can tolerate, and the patient will be treated for 360 s. After the treatment, 1.4 ml of a mixture of 0.4 mL of normal saline and 1 mL of 1% plain lidocaine will be injected through the needle of the cannula, and before the needle being removed, 0.5 mL of normal saline will be injected.<br>|
| Active Comparator: Nerve Block Group<br>This group will undergo nerve block treatment with steroid and local anesthesia. | Drug: Nerve block<br>* The radiofrequency generator will be set at the sensory stimulating mode, and the lowest frequency of 0.2 V will be used for 360s-sham PRF treatment, after which 1.4 mL of a mixture of 2 mg of dexamethasone sodium phosphate and 1 mL of 1% plain lidocaine will be slowly injected through the radiofrequency treatment cannula needle. Before the needle being removed, 0.5 mL of normal saline will be injected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective rate of Primary Trigeminal Neuralgia treatment | The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as excellent (BNI pain score I-II), good (BNI pain score III), and poor (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases * 100%. | 1 year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory. | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation | 
| Dosage of adjuvant antiepileptic drugs |  | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation | 
| Data regarding patients with a BNI of IV or V who switch to other treatments |  | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation | 
| Adverse events | Data regarding intraoperative and postoperative adverse events. | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion | 
| The postoperative response rate | The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as excellent (BNI pain score I-II), good (BNI pain score III), and poor (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases * 100%. | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trigeminal Neuralgia, Pulsed Radiofrequency, Gasserian Ganglion