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

NCT03131466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

  • Idiopathic Trigeminal Neuralgia

Interventions

DEVICE

High-voltage pulsed radiofrequency

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.

DRUG

Nerve block

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.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    collaborator OTHER

  • Beijing Ditan Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Fang Luo, M.D. · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2020-09-03
Completion
2021-09-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131466 on ClinicalTrials.gov