Clinical trial NCT04174443: The Efficacy and Safety of Pulsed Radiofrequency Combined With Continuous Radiofrequency for the Trigeminal Neuralgia
Official title: The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal neuralgia
Pulsed radiofrequency
Continuous radiofrequency
High-voltage pulsed radiofrequency combined with low-temperature continuous radiofrequency
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd Edition criteria.
* Aged 18-75 years (inclusive), no sex limitation.
* Suffering from severe trigeminal neuralgia that cannot be alleviated effectively using conservative medical therapy such as carbamazepine, oxcarbazepine.
* Numeric rating scale score≥7 before the procedure.
* Agreed to sign the informed consent form.

Exclusion Criteria:

* Secondary trigeminal neuralgia such as trigeminal neuralgia attributed to a space-occupying lesion or multiple sclerosis.
* Infection at the puncture site.
* A history of psychiatric disease.
* Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest X-ray.
* Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (II-III of the New York Heart Association classification).
* A history of abuse of narcotics.
* A history of receiving continuous radiofrequency to the gasserian ganglion or peripheral branches; glycerol rhizolysis; balloon compression; gamma knife; or any other neuroablative treatments.
* A history of receiving microvascular decompression.

Primary outcomes:
measure: The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III
timeFrame: Twelve months after the procedure
Secondary outcomes:
measure: The modified Barrow Neurological Institute Pain Intensity Score
timeFrame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
measure: Numeric rating scale
timeFrame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
measure: Dose of carbamazepine or oxcarbazepine
timeFrame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
measure: Patient satisfaction scores on the 5-point Likert scale
timeFrame: After 1, 6 and 12 months following the procedure
measure: The World Health Organization Quality of Life (WHOQOL)-BREF
timeFrame: After 1, 6 and 12 months following the procedure
measure: Numbness
timeFrame: On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
measure: Number of participants with anesthesia dolorosa
timeFrame: Within 12 months of the procedure
measure: Number of participants with masticator weakness
timeFrame: Within 12 months of the procedure
measure: Number of participants with corneal anesthesia
timeFrame: Within 12 months of the procedure
measure: Number of participants with keratitis
timeFrame: Within 12 months of the procedure
measure: Number of participants with adverse reactions
timeFrame: Within two weeks of the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ren H, Zhao C, Wang X, Shen Y, Meng L, Luo F. The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-Temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia: Study Protocol for a Prospective, Open-Label, Parall. Pain Physician. 2021 Jan;24(1):89-97.