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

Not Applicable

Completed

• Conditions: Idiopathic Trigeminal Neuralgia
• Interventions: Device: High-voltage pulsed radiofrequency; Drug: Nerve block

• Registration Number: NCT03131466
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-04-22
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Study Start: 2017-04-28
• Primary Completion: 2020-09-03
• Study Completion: 2021-09-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-24
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF Group	High-voltage pulsed radiofrequency	This group will undergo 42°C high-voltage pulsed radiofrequency treatment.
Nerve Block Group	Nerve block	This group will undergo nerve block treatment with steroid and local anesthesia.

Primary Outcome Measures

Name	Time	Method
Effective rate of Primary Trigeminal Neuralgia treatment	1 year after operation	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%.

Secondary Outcome Measures

Name	Time	Method
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	1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion	Data regarding intraoperative and postoperative adverse events.
The postoperative response rate	1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion	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%.
Patient satisfaction	1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation	Patient satisfaction score (PSS) score will be used to evaluate patient satisfaction: 0 point indicates unsatisfactory, while 10 points indicates very satisfactory.
Dosage of adjuvant antiepileptic drugs	1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation

Trial Locations

Locations (3)

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China