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

NCT04174443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2024-08-06

No results posted yet for this study

Summary

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.

Conditions

  • Trigeminal Neuralgia

Interventions

PROCEDURE

High-voltage pulsed radiofrequency

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.

PROCEDURE

Low-temperature continuous radiofrequency

Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Fang Luo, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2022-10-26
Completion
2022-10-26

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 NCT04174443 on ClinicalTrials.gov