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

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

Sponsors

Lead Sponsor: Beijing Tiantan Hospital

Collaborator: Beijing Friendship Hospital
Beijing Ditan Hospital

Source 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.

Overall Status Active, not recruiting
Start Date 2017-04-28
Completion Date 2021-09-04
Primary Completion Date 2020-09-03
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Effective rate of Primary Trigeminal Neuralgia treatment 1 year after operation
Secondary Outcome
Measure Time Frame
Patient satisfaction 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 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion
The postoperative response rate 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion
Enrollment 134
Condition
Intervention

Intervention Type: Device

Intervention Name: High-voltage pulsed radiofrequency

Description: 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.

Arm Group Label: PRF Group

Intervention Type: Drug

Intervention Name: Nerve block

Description: 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.

Arm Group Label: Nerve Block Group

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Fang Luo, M.D. Principal Investigator Beijing Tiantan Hospital
Location
Facility:
Beijing Ditan Hospital | Beijing, Beijing, 100015, China
Beijing Friendship Hospital | Beijing, Beijing, 100050, China
Beijing Tiantan Hospital | Beijing, Beijing, 100050, China
Location Countries

China

Verification Date

2020-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Beijing Tiantan Hospital

Investigator Full Name: Fang Luo

Investigator Title: vice director of Department of Anesthesiology and Pain Management

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PRF Group

Type: Experimental

Description: This group will undergo 42°C high-voltage pulsed radiofrequency treatment.

Label: Nerve Block Group

Type: Active Comparator

Description: This group will undergo nerve block treatment with steroid and local anesthesia.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News